Trial Outcomes & Findings for A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors (NCT NCT01946789)

NCT ID: NCT01946789

Last Updated: 2025-01-22

Results Overview

The safety endpoint is the MTD of ALT-803, defined as the dose level below that at which ≥2 of 6 patients experience a DLT.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

9 months

Results posted on

2025-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	N-803 IV 0.3/0.5 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Overall Study STARTED	2	3	3	3	3	3	4	3	2
Overall Study COMPLETED	2	1	1	0	1	0	0	2	0
Overall Study NOT COMPLETED	0	2	2	3	2	3	4	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	N-803 IV 1.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Overall Study Death	2	1	1	1	1	3	1	2
Overall Study Progressive Disease	0	1	0	0	2	0	0	0
Overall Study Withdrawal by Subject	0	0	2	1	0	1	0	0

Baseline Characteristics

A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803 in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-803 IV 0.3/0.5 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	Total n=26 Participants Total of all reporting groups
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	23 Participants n=42 Participants
Age, Continuous	38.0 years STANDARD_DEVIATION 15.56 • n=5 Participants	64.7 years STANDARD_DEVIATION 6.81 • n=7 Participants	58.7 years STANDARD_DEVIATION 10.26 • n=5 Participants	69.7 years STANDARD_DEVIATION 8.02 • n=4 Participants	59.3 years STANDARD_DEVIATION 5.13 • n=21 Participants	59.0 years STANDARD_DEVIATION 3.46 • n=8 Participants	63.3 years STANDARD_DEVIATION 9.88 • n=8 Participants	55.3 years STANDARD_DEVIATION 10.97 • n=24 Participants	64.0 years STANDARD_DEVIATION 19.8 • n=42 Participants	59.9 years STANDARD_DEVIATION 11.2 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	11 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	15 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	24 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Advanced Solid Tumors	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	26 Participants n=42 Participants

PRIMARY outcome

Timeframe: 9 months

The safety endpoint is the MTD of ALT-803, defined as the dose level below that at which ≥2 of 6 patients experience a DLT.

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Dose Limiting Toxicity	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 14 days post final dose, up to 135 days

Population: There were 2 participants in the N-803 IV 6.0 ug/kg, 1 participant in the N-803 Subcutaneous (SC) 6.0 ug/kg, and 1 participant in the N-803 Subcutaneous 20.0 ug/kg cohorts that had samples not collected. There were 2 subjects from the 6.0 ug/kg SC cohort whose samples were provided to the NantCell analytical laboratory and analyzed, but original assay reports could not be located and thus results cannot be reported.

Immunogenicity of ALT-803 assessed by ELISA

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Number of Participants Who Developed Anti-drug Antibodies to ALT-803	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 24 hours post dose

Population: Results not available for each participant at each parameter because results were below the level of detection

Pharmacokinetics of ALT-803 assessed by ELISA

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Half Life and Tmax) Half life	2.23 hours Interval 2.23 to 2.23	4.58 hours Interval 1.36 to 7.79	2.53 hours Interval 2.53 to 2.53	1.41 hours Interval 0.751 to 2.06	NA hours below the level of detection	NA hours below the level of detection	NA hours below the level of detection	NA hours below the level of detection	2.73 hours Interval 2.3 to 3.15	NA hours below the level of detection
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Half Life and Tmax) Tmax	0.583 hours Interval 0.583 to 0.583	0.542 hours Interval 0.517 to 0.567	0.667 hours Interval 0.533 to 0.8	0.650 hours Interval 0.55 to 0.75	6.06 hours Interval 4.0 to 8.12	24.0 hours Interval 23.9 to 24.0	16.1 hours Interval 8.0 to 24.3	16.1 hours Interval 8.12 to 24.0	0.508 hours Interval 0.5 to 0.517	0.500 hours Interval 0.5 to 0.5

SECONDARY outcome

Timeframe: 24 hours after first dose

Population: To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Cmax). Results not available for each participant at each parameter because insufficient measurable concentration data.

Pharmacokinetics of ALT-803 assessed by ELISA

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Cmax)	91.2 ng/mL Interval 91.2 to 91.2	11.5 ng/mL Interval 10.2 to 12.8	49.8 ng/mL Interval 39.9 to 59.6	86.0 ng/mL Interval 79.0 to 93.0	0.276 ng/mL Interval 0.152 to 0.401	0.352 ng/mL Interval 0.29 to 0.413	0.685 ng/mL Interval 0.443 to 0.928	0.280 ng/mL Interval 0.252 to 0.307	72.6 ng/mL Interval 26.5 to 119.0	2.26 ng/mL Interval 2.26 to 2.26

SECONDARY outcome

Timeframe: 24 hours after first dose

Population: Results not available for each participant at each parameter because results were below the level of detection.

Pharmacokinetics of ALT-803 assessed by ELISA

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg n=1 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (AUC 0-t, AUC0-24, AUC0-infinity) AUC 0-t	236 hr*ng/mL Interval 236.0 to 236.0	14.7 hr*ng/mL Interval 10.5 to 18.8	105 hr*ng/mL Interval 65.2 to 145.0	289 hr*ng/mL Interval 186.0 to 392.0	4.66 hr*ng/mL Interval 2.74 to 6.59	5.19 hr*ng/mL Interval 4.86 to 5.51	10.9 hr*ng/mL Interval 8.67 to 13.2	4.57 hr*ng/mL Interval 3.73 to 5.41	323 hr*ng/mL Interval 82.1 to 565.0	NA hr*ng/mL below the level of detection
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (AUC 0-t, AUC0-24, AUC0-infinity) AUC0-24	236 hr*ng/mL Interval 236.0 to 236.0	14.7 hr*ng/mL Interval 10.6 to 18.8	145 hr*ng/mL Interval 145.0 to 145.0	290 hr*ng/mL Interval 187.0 to 393.0	2.73 hr*ng/mL Interval 2.73 to 2.73	4.86 hr*ng/mL Interval 4.86 to 4.86	10.9 hr*ng/mL Interval 8.56 to 13.2	4.56 hr*ng/mL Interval 3.73 to 5.4	323 hr*ng/mL Interval 82.1 to 564.0	NA hr*ng/mL below the level of detection
To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (AUC 0-t, AUC0-24, AUC0-infinity) AUC0-infinity	236 hr*ng/mL Interval 236.0 to 236.0	15.0 hr*ng/mL Interval 10.5 to 19.4	145 hr*ng/mL Interval 145.0 to 145.0	290 hr*ng/mL Interval 187.0 to 393.0	NA hr*ng/mL below the level of detection	NA hr*ng/mL below the level of detection	NA hr*ng/mL below the level of detection	NA hr*ng/mL below the level of detection	324 hr*ng/mL Interval 82.4 to 565.0	NA hr*ng/mL below the level of detection

SECONDARY outcome

Timeframe: Cycle 1 Week 1, pre-dose; Cycle 1 Week 1, 30 minutes post dose; Cycle 1 Week 1, 2 hours post dose; Cycle 1 Week 1, 4 hours post dose; Cycle 1 Week 1, 8 hours post dose; Cycle 1 Week 1, 24 hours post dose

The level of immune response to autochthonous viral and tumor antigens by interferon gamma (IFN-γ) ELISPOT

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ) C1, W1 pre dose	2.7 pg/mL Standard Deviation 0.5037	1.528 pg/mL Standard Deviation 2.1609	2.015 pg/mL Standard Deviation 2.8496	0 pg/mL Standard Deviation 0	0.326 pg/mL Standard Deviation 0.3833	2.741 pg/mL Standard Deviation 2.3792	2.659 pg/mL Standard Deviation 4.6059	4.445 pg/mL Standard Deviation 7.6987	5.955 pg/mL Standard Deviation 0.5356	—
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ) C1, W1 30min post dose	0 pg/mL Standard Deviation 0	3.433 pg/mL Standard Deviation 4.8551	1.420 pg/mL Standard Deviation 2.0082	0 pg/mL Standard Deviation 0	0.163 pg/mL Standard Deviation 0.2829	0.692 pg/mL Standard Deviation 1.1994	2.659 pg/mL Standard Deviation 4.6059	1.394 pg/mL Standard Deviation 2.4152	2.397 pg/mL Standard Deviation 3.3896	—
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ) C1, W1 2 hr post dose	21.827 pg/mL Standard Deviation 25.6506	22.585 pg/mL Standard Deviation 2.9941	30.605 pg/mL Standard Deviation 36.7908	10.198 pg/mL Standard Deviation 13.8527	0 pg/mL Standard Deviation 0	1.525 pg/mL Standard Deviation 1.3373	0 pg/mL Standard Deviation 0	1.463 pg/mL Standard Deviation 2.5342	43.863 pg/mL Standard Deviation 42.2211	—
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ) C1, W1 4 hr post dose	64.947 pg/mL Standard Deviation 85.0197	47.160 pg/mL Standard Deviation 37.1485	57.660 pg/mL Standard Deviation 56.4978	23.295 pg/mL Standard Deviation 28.1061	1.146 pg/mL Standard Deviation 1.7892	1.771 pg/mL Standard Deviation 2.2307	0.607 pg/mL Standard Deviation 1.0506	1.325 pg/mL Standard Deviation 2.2943	78.729 pg/mL Standard Deviation 63.0940	—
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ) C1, W1 8 hr post dose	10.022 pg/mL Standard Deviation 14.1731	11.158 pg/mL Standard Deviation 4.7186	15.3 pg/mL Standard Deviation 9.8995	7.597 pg/mL Standard Deviation 9.5858	0 pg/mL Standard Deviation 0	2.123 pg/mL Standard Deviation 1.1098	2.479 pg/mL Standard Deviation 4.2939	1.598 pg/mL Standard Deviation 2.7676	22.293 pg/mL Standard Deviation 11.2426	—
To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ) C1, W1 24 hr post dose	0 pg/mL Standard Deviation 0	0.728 pg/mL Standard Deviation 1.0292	0.73 pg/mL Standard Deviation 1.0324	0 pg/mL Standard Deviation 0	0.84 pg/mL Standard Deviation 0.7962	3.825 pg/mL Standard Deviation 0.5214	4.389 pg/mL Standard Deviation 7.6013	1.664 pg/mL Standard Deviation 2.8823	4.078 pg/mL Standard Deviation 5.7676	—

SECONDARY outcome

Timeframe: Up to 6 months

Number of patients with CR, PR, SD, and PD

Outcome measures

Outcome measures
Measure	N-803 IV 0.3/0.5 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 Participants ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 0.5ug/kg ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Objective Response Rate Progressive disease	0 Participants	2 Participants	1 Participants	3 Participants	0 Participants	3 Participants	1 Participants	2 Participants	1 Participants	—
Objective Response Rate Stable disease	2 Participants	1 Participants	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	1 Participants	—

Adverse Events

N-803 IV 0.3/0.5 ug/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

N-803 IV 1.0 ug/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

N-803 IV 3.0 ug/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

N-803 IV 6.0 ug/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

N-803 Subcutaneous 6.0 ug/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

N-803 Subcutaneous 10.0 ug/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

N-803 Subcutaneous 15.0 ug/kg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

N-803 Subcutaneous 20.0 ug/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	N-803 IV 0.3/0.5 ug/kg n=2 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Disease progression	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Injection site reaction	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Pyrexia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Headache	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Renal and urinary disorders Haematuria	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.

Other adverse events

Other adverse events
Measure	N-803 IV 0.3/0.5 ug/kg n=2 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 1.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 3.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 IV 6.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 6.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 10.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 15.0 ug/kg n=4 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Subcutaneous 20.0 ug/kg n=3 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.	N-803 Intratumoral 10.0 ug/kg Followed by N-803 15.0 ug/kg Subcutaneous n=2 participants at risk ALT-803: N-803 will be administered at the following doses intravenously: 0.3/0.5, 1.0, 3.0, 6.0 ug/kg N-803 will be administered at the following does subcutaneously: 6.0, 10.0, 15.0, 20.0 ug/kg N-803 will be administered intratumorally at a dose of 10.0 ug/kg, followed by N-803 administered subcutaneously at a dose of 15.0 ug/kg. Each treatment cycle consists of 4 weeks on therapy and 2 weeks off. Patients will receive weekly dose of ALT-803 for 4 weeks (Days 1, 8, 15, and 22) used for the identification of the OBD and MTD. After a 2-week rest period (Weeks 5 and 6) and recovery of any dose limiting toxicities to grade 0-1 of Cycle 1, a second 6-week cycle (4 weeks on treatment and 2 weeks off) can begin. After a rest period during Weeks 5 and 6 of Cycle 2, stable or benefitting patients assessed at week 8 +/- 1 may receive up to 2 additional 6-week cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	75.0% 3/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Cardiac disorders Palpitations	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Cardiac disorders Sinus tachycardia	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Cardiac disorders Tachycardia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Eye disorders Dry Eye	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Eye disorders Eye haemorrhage	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Abdominal discomfort	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Constipation	0.00% 0/2 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Nausea	100.0% 2/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Oral pain	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Asthenia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Axillary pain	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Chills	50.0% 1/2 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
General disorders Disease progression	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Fatigue	100.0% 2/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	100.0% 3/3 • Up to 385 days.	75.0% 3/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
General disorders Hypothermia	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Injection site extravasation	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Injection site reaction	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	100.0% 4/4 • Up to 385 days.	100.0% 3/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
General disorders Malaise	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Oedema peripheral	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 2/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Pain	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Peripheral swelling	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Pyrexia	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
General disorders Swelling	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
General disorders Systemic inflammatory response syndrome	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Infections and infestations Candida infection	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Infections and infestations Nasopharyngitis	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Infections and infestations Pneumonia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Infections and infestations Sinusitis	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Infections and infestations Urinary tract infection	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Injury, poisoning and procedural complications Stoma site erythema	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Alanine aminotransferase increased	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 2/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Blood creatinine decreased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Blood iron decreased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Lymphocyte count decreased	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	50.0% 2/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
Investigations Neutrophil count decreased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Investigations Platelet count decreased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Investigations Weight decreased	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Investigations White blood cell count decreased	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Metabolism and nutrition disorders Hyperglycaemia	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Metabolism and nutrition disorders Hyperphosphataemia	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	100.0% 3/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 2/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	100.0% 2/2 • Up to 385 days.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 2/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	50.0% 1/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Balance disorder	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Central nervous system lesion	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Diziness	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Dysgeusia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Headache	50.0% 1/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	66.7% 2/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Paraesthesia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Nervous system disorders Sciatica	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Psychiatric disorders Abnormal dreams	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Psychiatric disorders Insomnia	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Psychiatric disorders Mood altered	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Renal and urinary disorders Haematuria	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Renal and urinary disorders Proteinuria	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Renal and urinary disorders Urinary retention	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	50.0% 2/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Erythema	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Hyperhidrosis	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Pruritus	100.0% 2/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Skin discomfort	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Vascular disorders Flushing	50.0% 1/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Vascular disorders Hypertension	0.00% 0/2 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/4 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.
Vascular disorders Hypotension	0.00% 0/2 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	0.00% 0/3 • Up to 385 days.	25.0% 1/4 • Up to 385 days.	33.3% 1/3 • Up to 385 days.	0.00% 0/2 • Up to 385 days.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place