Trial Outcomes & Findings for Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer (NCT NCT02240238)

Last Updated: 2025-01-22

Results Overview

In the dose-escalation phase of the study (Part 1), to determine the dose-limiting toxicities (DLTs), MTD, and RPII dose of NC-6004 in combination with gemcitabine

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

119 participants

Primary outcome timeframe

1 year

Results posted on

2025-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 NC-6004 60 mg/m^2 Participants received intravenous (IV) infusion of NC-6004 60 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 75 mg/m^2 Participants received IV infusion of NC-6004 75 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 90 mg/m^2 Participants received IV infusion of NC-6004 90 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 105 mg/m^2 Participants received IV infusion of NC-6004 105 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 120 mg/m^2 Participants received IV infusion of NC-6004 120 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 135 mg/m^2 Participants received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 150 mg/m^2 Participants received IV infusion of NC-6004 150 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 165 mg/m^2 Participants received IV infusion of NC-6004 165 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 180 mg/m^2 Participants received IV infusion of NC-6004 180 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 2 Cohort 1 (NSCLC) Participants with non-small-cell lung cancer (NSCLC) received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.	Phase 2 Cohort 2 (Biliary Tract Cancer) Participants with biliary tract cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 8 cycles.	Phase 2 Cohort 3 (Bladder Cancer) Participants with bladder cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.
Phase 1 STARTED	1	1	1	1	1	9	6	1	1	0	0	0
Phase 1 COMPLETED	1	1	1	1	1	3	3	0	1	0	0	0
Phase 1 NOT COMPLETED	0	0	0	0	0	6	3	1	0	0	0	0
Phase 2 STARTED	0	0	0	0	0	0	0	0	0	34	50	13
Phase 2 COMPLETED	0	0	0	0	0	0	0	0	0	15	14	8
Phase 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0	19	36	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 NC-6004 135 mg/m^2 Participants received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 150 mg/m^2 Participants received IV infusion of NC-6004 150 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 165 mg/m^2 Participants received IV infusion of NC-6004 165 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 2 Cohort 1 (NSCLC) Participants with non-small-cell lung cancer (NSCLC) received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.	Phase 2 Cohort 2 (Biliary Tract Cancer) Participants with biliary tract cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 8 cycles.	Phase 2 Cohort 3 (Bladder Cancer) Participants with bladder cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.
Phase 1 Adverse Event	0	3	1	0	0	0
Phase 1 Death	1	0	0	0	0	0
Phase 1 Sponsor termination	1	0	0	0	0	0
Phase 1 Withdrawal by Subject	2	0	0	0	0	0
Phase 1 Physician Decision	2	0	0	0	0	0
Phase 2 Adverse Event	0	0	0	7	14	2
Phase 2 Death	0	0	0	3	2	1
Phase 2 Disease progression	0	0	0	5	11	1
Phase 2 Withdrawal by Subject	0	0	0	1	1	0
Phase 2 Physician Decision	0	0	0	1	3	0
Phase 2 PARTICIPANT WAS DISCONTINUED DUE TO THEIR DETERIORATING CONDITION/CLINICAL PROGRESSION	0	0	0	1	0	0
Phase 2 TREATMENT NOT COMPLETED, PARTICIPANT MISSED C6D8 DUE TO PERSONAL REASON	0	0	0	1	0	0
Phase 2 PARTICIPANT DECIDED TO TAKE STANDARD OF CARE TREATMENT	0	0	0	0	1	0
Phase 2 TREATMENT DELAY >14 DAYS	0	0	0	0	1	0
Phase 2 PARTICIPANT WAS DECLINING CLINICALLY	0	0	0	0	1	0
Phase 2 PARTICIPANT DECIDED TO COME OFF THE STUDY AS STUDY WAS ON HOLD. AND DECIDED TO MOVE TO SOC	0	0	0	0	1	0
Phase 2 CONTINUE WITH ONLY GEMCITABINE, AS PER PARTICIPANT DECISION	0	0	0	0	1	0
Phase 2 TREATMENT DELAY GREATER THAN 14 DAYS	0	0	0	0	0	1

Baseline Characteristics

Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 NC-6004 60 mg/m^2 n=1 Participants Participants received intravenous (IV) infusion of NC-6004 60 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 75 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 75 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 90 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 90 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 105 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 105 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 120 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 120 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 135 mg/m^2 n=9 Participants Participants received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 150 mg/m^2 n=6 Participants Participants received IV infusion of NC-6004 150 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 165 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 165 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 180 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 180 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 2 Cohort 1 (NSCLC) n=33 Participants Participants with non-small-cell lung cancer (NSCLC) received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.	Phase 2 Cohort 2 (Biliary Tract Cancer) n=49 Participants Participants with biliary tract cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 8 cycles.	Phase 2 Cohort 3 (Bladder Cancer) n=12 Participants Participants with bladder cancer received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles for up to 6 cycles.	Total n=116 Participants Total of all reporting groups
Age, Categorical Phase 1 · <=18 years	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Categorical Phase 1 · Between 18 and 65 years	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	7 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	6 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	18 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Categorical Phase 1 · >=65 years	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	4 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Categorical Phase 2 · <=18 years	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Categorical Phase 2 · Between 18 and 65 years	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	22 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	32 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	6 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	60 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Categorical Phase 2 · >=65 years	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	11 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	17 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	6 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	34 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Continuous Phase 1	54.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	67.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	56.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	69.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	37.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	60.0 years STANDARD_DEVIATION 7.75 • n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	33.7 years STANDARD_DEVIATION 9.42 • n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	62.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	61.0 years STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	52.2 years STANDARD_DEVIATION 14.57 • n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Age, Continuous Phase 2	—	—	—	—	—	—	—	—	—	61.7 years STANDARD_DEVIATION 9.10 • n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	62.6 years STANDARD_DEVIATION 8.51 • n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	65.2 years STANDARD_DEVIATION 11.87 • n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	62.6 years STANDARD_DEVIATION 9.04 • n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Sex: Female, Male Phase 1 · Female	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	5 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	3 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	11 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Sex: Female, Male Phase 1 · Male	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	4 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	3 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	11 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Sex: Female, Male Phase 2 · Female	—	—	—	—	—	—	—	—	—	7 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	18 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	26 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Sex: Female, Male Phase 2 · Male	—	—	—	—	—	—	—	—	—	26 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	31 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	11 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	68 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Ethnicity (NIH/OMB) Phase 1 · Hispanic or Latino	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	4 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Ethnicity (NIH/OMB) Phase 1 · Not Hispanic or Latino	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	8 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	3 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	15 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Ethnicity (NIH/OMB) Phase 1 · Unknown or Not Reported	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	3 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Ethnicity (NIH/OMB) Phase 2 · Hispanic or Latino	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Ethnicity (NIH/OMB) Phase 2 · Not Hispanic or Latino	—	—	—	—	—	—	—	—	—	33 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	47 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	12 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	92 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Ethnicity (NIH/OMB) Phase 2 · Unknown or Not Reported	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · American Indian or Alaska Native	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	0 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · Asian	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	1 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	0 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · Black or African American	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	5 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · White	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	7 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	13 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · More than one race	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	0 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 1 · Unknown or Not Reported	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	3 Participants n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · American Indian or Alaska Native	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · Asian	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · Native Hawaiian or Other Pacific Islander	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · Black or African American	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	1 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · White	—	—	—	—	—	—	—	—	—	33 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	44 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	11 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	88 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · More than one race	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Race (NIH/OMB) Phase 2 · Unknown or Not Reported	—	—	—	—	—	—	—	—	—	0 Participants n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	0 Participants n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	2 Participants n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Height Phase 1	187.0 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	181.0 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	165.10 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	189.20 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	162.60 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	171.08 cm STANDARD_DEVIATION 12.473 • n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	175.67 cm STANDARD_DEVIATION 13.803 • n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	164.00 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	180.30 cm STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	173.73 cm STANDARD_DEVIATION 12.125 • n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Height Phase 2	—	—	—	—	—	—	—	—	—	170.98 cm STANDARD_DEVIATION 8.724 • n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	169.23 cm STANDARD_DEVIATION 8.847 • n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	172.02 cm STANDARD_DEVIATION 4.183 • n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	170.14 cm STANDARD_DEVIATION 8.323 • n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Weight Phase 1	84.10 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	84.10 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	72.70 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	104.70 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	120.10 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	72.93 kg STANDARD_DEVIATION 15.336 • n=9 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	72.45 kg STANDARD_DEVIATION 13.307 • n=6 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	62.90 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	110.70 kg STANDARD_DEVIATION NA • n=1 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	—	—	—	78.65 kg STANDARD_DEVIATION 18.333 • n=22 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.
Weight Phase 2	—	—	—	—	—	—	—	—	—	70.47 kg STANDARD_DEVIATION 17.877 • n=33 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	73.57 kg STANDARD_DEVIATION 16.527 • n=49 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	83.83 kg STANDARD_DEVIATION 13.355 • n=12 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.	74.16 kg STANDARD_DEVIATION 17.214 • n=94 Participants • Three patients in Part 2 were diagnosed incorrectly resulting in assignment to the incorrect cohort. These patients are not included in the cohort summaries.

PRIMARY outcome

Timeframe: 1 year

Population: Number of participants with at lease one DLT

In the dose-escalation phase of the study (Part 1), to determine the dose-limiting toxicities (DLTs), MTD, and RPII dose of NC-6004 in combination with gemcitabine

Outcome measures

Outcome measures
Measure	Phase 1 NC-6004 60 mg/m^2 n=1 Participants Participants received intravenous (IV) infusion of NC-6004 60 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 75 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 75 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 90 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 90 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 105 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 105 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 120 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 120 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 135 mg/m^2 n=9 Participants Participants received IV infusion of NC-6004 135 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 150 mg/m^2 n=6 Participants Participants received IV infusion of NC-6004 150 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 165 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 165 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.	Phase 1 NC-6004 180 mg/m^2 n=1 Participants Participants received IV infusion of NC-6004 180 mg/m\^2 on Day 1 and gemcitabine 1250 mg/m\^2 on Days 1 and 8 in 3-week treatment cycles until they experienced disease progression.
Determine the RPII Dose of NC-6004 in Combination With Gemcitabine	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	4 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 1 year

In the expansion phase of the study (Part 2), to evaluate the activity of NC-6004 in combination with gemcitabine in patients with first-line Stage IV squamous NSCLC, first-line advanced or metastatic biliary tract cancer, and first-line metastatic or locally advanced bladder cancer compared with historical control as measured by local investigator/radiologist-assessed progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.