Trial Outcomes & Findings for Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (NCT NCT04574583)

Last Updated: 2025-02-03

Results Overview

A DLT is defined as any one of the following adverse events (AEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE v5.0), that is possibly attributable to study drugs by the Investigator, that occur within 28 days after the start of study therapy: Any Grade 4 (life threatening) AEs, except for example, laboratory values that are determined to not be clinically significant or single laboratory valued that resolve to Grade ≤ 1 or baseline grade within 7 days with adequate medical management. Average corrected QT interval by Fridericia (QTcF)≥ 501 msec or \> 60 msec change from baseline (Grade 3). Any Grade 3 (severe) AEs except for example, Grade 3 flu-like symptoms or fever, as well as associated symptoms of fatigue, headaches, nausea, emesis which can be controlled with conservative medical management. Any grade 3 or higher adverse event or unexpected toxicities due to the combination of therapies that would not be expected with individual agents alone.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

DLT observation period (first 4 weeks)

Results posted on

2025-02-03

Participant Flow

The trial never reached the point of enrolling to phase 2. It stopped early before maximum tolerated dose (MTD) was reached.

Participant milestones

Participant milestones
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Overall Study STARTED	3	6	3
Overall Study COMPLETED	3	6	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: DLT observation period (first 4 weeks)

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Dose Limiting Toxicities (DLT)	0 toxicities	1 toxicities	0 toxicities

PRIMARY outcome

Timeframe: Approximately 16 months and 11 days

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to AE.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301 Grade 3 Related	2 Participants	2 Participants	2 Participants
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301 Grade 3 Unrelated	1 Participants	4 Participants	2 Participants
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301 Grade 4 Unrelated	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301 Grade 4 Related	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301 Grade 5 Related	0 Participants	0 Participants	0 Participants
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301 Grade 5 Unrelated	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Period of Safety lead-in (monotherapy), approximately 28 days

The MTD is the dose at which no more than 1 of 6 subjects taking SX-682 followed by M7824 and CV301 vaccines experience a dose-limiting toxicity (DLT). A DLT is defined as any one of the following adverse events (AEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE v5.0), that is possibly attributable to study drugs by the Investigator, that occur within 28 days after the start of study therapy.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=12 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Maximum Tolerated Dose (MTD) of SX-682 Followed by BinTrafusp Alfa (M7824) and CV301 Vaccines in Participants With Advanced or Metastatic Solid Tumors.	NA mg The MTD was not established because the study was stopped due to toxicity.	—	—

PRIMARY outcome

Timeframe: Approximately 28 days

Recommended phase II dose is defined as the dose defined in the phase I portion of a study that will be administered to participants on the phase II portion.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=12 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Recommended Phase II Dose (RP2D) of SX-682 With BinTrafusp Alfa (M7824) and CV301 Vaccines in Participants With Advanced or Metastatic Solid Tumors.	NA mg The RP2D was not established because the study was stopped due to toxicity.	—	—

PRIMARY outcome

Timeframe: 11 months

Population: 2 participants were not evaluable for this outcome measure.

The percentage of participants who experience a response will be reported along with 95% two-sided confidence intervals. The objective response is the best overall response recorded from the start of treatment until disease progression/recurrence per the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=5 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=2 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Percentage of Participants Who Experience a Response Partial Response	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experience a Response Stable Disease	100 percentage of participants	60 percentage of participants	0 percentage of participants
Percentage of Participants Who Experience a Response Complete Response	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Who Experience a Response Progressive Disease	100 percentage of participants	40 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Date first participant enrolled and ending on the off treatment date of the last participant on treatment (i.e., assessed beyond the primary completion date), approximately 15 months and 14 days.

Population: 2 participants were not evaluable for this outcome measure. The Rows were not planned to be mutually exhaustive and consisted of only those participants with response.

The percentage of participants disease control rate (DCR): Complete response (CR)+ partial response (PR) + stable disease (SD) was measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=5 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=2 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Percentage of Participants Disease Control Rate (DCR): Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) Complete Response	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Disease Control Rate (DCR): Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) Stable Disease	100 percentage of participants	60 percentage of participants	0 percentage of participants
Percentage of Participants Disease Control Rate (DCR): Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) Partial Response	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, approximately 10 months

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression per the RECIST is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors (RECIST)1.1.	2.0 months Interval 1.5 to 6.9	3.4 months Interval 1.0 to 10.4	1.8 months Interval 1.3 to 2.3

SECONDARY outcome

Timeframe: Predose, 30 minutes, 60 minutes, 120 minutes, <6 hours of 2nd dose, and end of infusion (EOI)

Population: Blood samples were collected on only a subset of participants because the study was closed to enrollment early due to a safety stopping rule pre-specified in the protocol. Since no participants received SX-682 treatment in combination, with bintrasfusp alfa and CV-301, the PK analysis cannot be performed completely as outlined in the study objectives. Below are analyses of all available participant samples.

Plasma and serum samples will be drawn and may be analyzed by a validated immunoassay to quantitate SX-682 as a single agent and in combination or by a validated electrochemiluminescence immunoassay to detect the presence of M7824 concentration.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - 120 minutes, Day 14	31.3 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - PRE, Day 14	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - 180 minutes, Day 14	124 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - <6 hours (HR) of 2nd dose, Day 14	105 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - PRE, Day 7	214 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - End of infusion (EOI), C1D1	116 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - PRE, Cycle 1 Day 15 (C1D15)	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - 180 minutes, Day 14	448 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - End of infusion (EOI), C1D1	587 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - 30 minutes, Day 7	51.2 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - PRE, Cycle 1 Day 1 (C1D1)	170 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - End of infusion (EOI), C1D1	84 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - PRE, Cycle 1 Day 15 (C1D15)	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - PRE, Cycle 2 Day 1 (C2D1)	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - PRE, Cycle 3 Day 1 (C3D1)	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - PRE, Day 7	—	1660 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - 180 minutes, Day 14	—	341 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - <6 hours (HR) of 2nd dose, Day 14	—	260 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - End of infusion (EOI), C1D1	—	429 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - PRE, Cycle 1 Day 15 (C1D15)	—	1.25 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - PRE, Cycle 3 Day 1 (C3D1)	—	NA ng/ml Below quantifiable limit (BQL)/Treatment (tx) restart	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - PRE, Day 14	—	—	NA ng/ml Below quantifiable limit (BQL)
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - 60 minutes, Day 14	—	—	104 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - 120 minutes, Day 14	—	—	165 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - PRE, Cycle 1 Day 1 (C1D1)	—	—	7120 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - End of infusion (EOI), C1D1	—	—	6320 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - 30 minutes, Day 14	7.88 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - 60 minutes, Day 14	17.7 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - 120 minutes, Day 14	104 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - 30 minutes, Day 7	193 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - PRE, Cycle 1 Day 1 (C1D1)	325 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 1 - PRE, Cycle 2 Day 1 (C2D1)	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - PRE, Day 14	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - 30 minutes, Day 14	216 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - 60 minutes, Day 14	460 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - 120 minutes, Day 14	483 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - <6 hours (HR) of 2nd dose, Day 14	184 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - PRE, Day 7	421 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - 30 minutes, Day 7	394 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - PRE, Cycle 1 Day 1 (C1D1)	778 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 2 - PRE, Cycle 1 Day 15 (C1D15)	1.24 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - PRE, Day 14	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - 30 minutes, Day 14	NA ng/ml Below quantifiable limit (BQL)	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - 60 minutes, Day 14	6.13 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - 180 minutes, Day 14	65.6 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3- <6 hours (HR) of 2nd dose, Day 14	99.7 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 3 - PRE, Day 7	53.7 ng/ml	—	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - PRE, Day 14	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - 30 minutes, Day 14	—	10.9 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - 60 minutes, Day 14	—	38.2 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - 120 minutes, Day 14	—	148 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - 180 minutes, Day 14	—	160 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - <6 hours (HR) of 2nd dose, Day 14	—	225 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - PRE, Day 7	—	710 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - 30 minutes, Day 7	—	827 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - PRE, Cycle 1 Day 1 (C1D1)	—	902 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - End of infusion (EOI), C1D1	—	501 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - PRE, Cycle 1 Day 15 (C1D15)	—	1.56 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 4 - End of treatment (EOT), Cycle 2 Day 1 (C2D1)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - PRE, Day 14	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - 30 minutes, Day 14	—	11.9 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - 60 minutes, Day 14	—	27.4 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - 120 minutes, Day 14	—	439 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - 180 minutes, Day 14	—	706 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - <6 hours (HR) of 2nd dose, Day 14	—	419 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - 30 minutes, Day 7	—	1940 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - PRE, Cycle 1 Day 1 (C1D1)	—	3170 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 5 - End of infusion (EOI), C1D1	—	1660 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - PRE, Day 14	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - 30 minutes, Day 14	—	32 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - 60 minutes, Day 14	—	219 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - 120 minutes, Day 14	—	395 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - PRE, Day 7	—	679 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - 30 minutes, Day 7	—	777 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - PRE, Cycle 1 Day 1 (C1D1)	—	683 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - PRE, Cycle 2 Day 1 (C2D1)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 6 - PRE, Cycle 3 Day 1 (C3D1)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - PRE, Day 14	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - 30 minutes, Day 14	—	97.1 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - 60 minutes, Day 14	—	110 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - 120 minutes, Day 14	—	54.2 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - 180 minutes, Day 14	—	705 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - <6 hours (HR) of 2nd dose, Day 14	—	489 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - PRE, Day 7	—	1900 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - 30 minutes, Day 7	—	1870 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - PRE, Cycle 1 Day 1 (C1D1)	—	1840 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 7 - End of infusion (EOI), C1D1	—	1070 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - PRE, Day 14	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - 30 minutes, Day 14	—	8.68 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - 60 minutes, Day 14	—	394 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - 120 minutes, Day 14	—	467 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - 180 minutes, Day 14	—	443 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - <6 hours (HR) of 2nd dose, Day 14	—	199 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - PRE, Day 7	—	480 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - 30 minutes, Day 7	—	455 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - PRE, Cycle 1 Day 1 (C1D1)	—	465 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - End of infusion (EOI), C1D1	—	478 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - PRE, Cycle 1 Day 15 (C1D15)	—	1.54 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - PRE, Cycle 2 Day 1 (C2D1)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 8 - PRE, Cycle 3 Day 1 (C3D1)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - PRE, Day 14	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - 30 minutes, Day 14	—	2.63 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - 60 minutes, Day 14	—	37.9 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - 120 minutes, Day 14	—	113 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - 180 minutes, Day 14	—	305 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - <6 hours (HR) of 2nd dose, Day 14	—	350 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - PRE, Cycle 1 Day 1 (C1D1)	—	424 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - End of infusion (EOI), C1D1	—	416 ng/ml	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - PRE, Cycle 1 Day 15 (C1D15)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - PRE, Cycle 2 Day 1 (C2D1)	—	NA ng/ml Below quantifiable limit (BQL)	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 9 - Cycle 3 Day 1 (C3D1)	—	NA ng/ml Below quantifiable limit (BQL)/Treatment (tx) held	—
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - 30 minutes, Day 14	—	—	NA ng/ml Below quantifiable limit (BQL)
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - 60 minutes, Day 14	—	—	1.28 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - 120 minutes, Day 14	—	—	39.2 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - 180 minutes, Day 14	—	—	155 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - <6 hours (HR) of 2nd dose, Day 14	—	—	329 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - PRE, Day 7	—	—	991 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - 30 minutes, Day 7	—	—	1220 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - PRE, Cycle 1 Day 1 (C1D1)	—	—	923 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - End of infusion (EOI), C1D1	—	—	745 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 10 - PRE, Cycle 1 Day 15 (C1D15)	—	—	NA ng/ml Below quantifiable limit (BQL)
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - PRE, Day 14	—	—	NA ng/ml Below quantifiable limit (BQL)
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - 30 minutes, Day 14	—	—	217 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - 60 minutes, Day 14	—	—	546 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - 120 minutes, Day 14	—	—	1090 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - 180 minutes, Day 14	—	—	1610 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - <6 hours (HR) of 2nd dose, Day 14	—	—	670 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - PRE, Day 7	—	—	5140 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - 30 minutes, Day 7	—	—	7390 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - Cycle 1 Day 1 (C1D1), Treatment held	—	—	7470 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 11 - End of treatment (EOT)	—	—	1.53 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - PRE, Day 14	—	—	NA ng/ml Below quantifiable limit (BQL)
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - 30 minutes, Day 14	—	—	54.7 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - 180 minutes, Day 14	—	—	795 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - <6 hours (HR) of 2nd dose, Day 14	—	—	1380 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - PRE, Day 7	—	—	5100 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - 30 minutes, Day 7	—	—	4920 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - PRE, C1D15, M7824 held	—	—	14.6 ng/ml
Pharmacokinetic Profile of SX-682 as a Single Agent and in Combination Participant 12 - End of treatment (EOT), C2D1	—	—	2.13 ng/ml

SECONDARY outcome

Timeframe: Predose, 30 minutes, 60 minutes, 120 minutes, <6 hours of 2nd dose, and end of infusion (EOI)

Population: No blood samples were collected because the study was closed prior to enrollment of any participants who would have received combination. Early closure was due to a safety stopping rule pre-specified in the protocol. Since no participants received SX-682 treatment in combination, with bintrasfusp alfa and CV-301, PK analysis cannot be performed as outlined in the study objectives. We cannot assess this endpoint without samples from participants treated with SX-682 + bintrasfusp alfa and CV-301.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	3 Participants	6 Participants	3 Participants

Adverse Events

Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 participants at risk Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 participants at risk Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 participants at risk Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Infections and infestations Urinary tract infection	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
General disorders Disease progression	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Gastrointestinal disorders Esophageal hemorrhage	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Renal and urinary disorders Hematuria	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Hepatobiliary disorders Hepatobiliary disorders - Other, hepatobiliary dilatation	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, COVID-19 infection	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/6 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.
Nervous system disorders Stroke	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.	0.00% 0/3 • Date treatment consent signed to date off study, approximately 5 months and 9 days, 13 months and 17 days, and 6 months and 1 day for DL1, DL2, and DL3 respectively. Adverse events were assessed beyond the primary completion date.

Other adverse events

Additional Information

Dr. James Gulley

National Cancer Institute

Phone: 301-480-8870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 25 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301 n=6 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL2 50 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrollment to the next dose level begins	Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301 n=3 Participants Participants with any solid tumor will receive a 2- week monotherapy lead-in of SX-682 DL1 100 mg by mouth (PO) twice a day (BID) followed sequentially by treatment with a dual combination of + BinTrafusp Alfa (M7824) 1200 mg fixed dose intravenous (IV) + BN-CV301. Participants will be evaluated for dose-limiting toxicities at the completion of the dose level before enrolling onto the next dose level.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Age, Continuous	61.53 years STANDARD_DEVIATION 5.23 • n=5 Participants	59.38 years STANDARD_DEVIATION 6.08 • n=7 Participants	54 years STANDARD_DEVIATION 13.29 • n=5 Participants	58.58 years STANDARD_DEVIATION 7.89 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 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
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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 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
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
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 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
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
Region of Enrollment United States	3 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	12 participants n=4 Participants