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)
CompletedPhase 1, PHASE2Results postedLast updated 3 February 2025
What this trial tests
Phase 1, PHASE2 trial testing SX-682 in Metastatic Cancer in 12 participants. Completed in 19 May 2023.
18 and older, any sex, with Metastatic Cancer or Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dose Limiting Toxicities (DLT)Primary· DLT observation period (first 4 weeks)
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 fro
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
1
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
0
Number of Participants With Grades 3-5 Adverse Events (AEs) Related and/or Unrelated to SX-682 + BinTrafusp Alfa (M7824) + BN-CV301Primary· 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.
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
1
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
0
Maximum Tolerated Dose (MTD) of SX-682 Followed by BinTrafusp Alfa (M7824) and CV301 Vaccines in Participants With Advanced or Metastatic Solid Tumors.Primary· 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.
Group
Value
95% CI
All Participants
NA
Recommended Phase II Dose (RP2D) of SX-682 With BinTrafusp Alfa (M7824) and CV301 Vaccines in Participants With Advanced or Metastatic Solid Tumors.Primary· 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.
Group
Value
95% CI
All Participants
NA
Percentage of Participants Who Experience a ResponsePrimary· 11 months
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 su
Phase I Solid Tumor Dose Level 3 (DL3) Disease-Specific Expansion
100
Percentage of Participants Disease Control Rate (DCR): Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD)Secondary· 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.
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
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
60
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
0
Progression-free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors (RECIST)1.1.Secondary· 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.
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
3.4
1.0 – 10.4
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
1.8
1.3 – 2.3
Pharmacokinetic Profile of SX-682 as a Single Agent and in CombinationSecondary· Predose, 30 minutes, 60 minutes, 120 minutes, <6 hours of 2nd dose, and end of infusion (EOI)
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.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)Secondary· 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
Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301
6
Phase I Dose Level 3 (DL3) 100 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa +CV301
3
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors.
Objective:
To find a safe dose of SX-682 in combined treatment with Bintrafusp alfa and BN-CV301 vaccines and to see if this treatment will cause tumors to shrink.
Eligibility:
Adults age 18 and older with metastatic cancer may be eligible for the first part of the trial. Adults age 18 and older with metastatic triple negative breast cancer or p16 negative head and neck squamous cell cancer, and who are not candidates for curative surgery may be eligible for the second part of the trial.
Design:
Participants will be screened under a separate protocol.
Participants may have tumor biopsies. They will have physical exams. Their symptoms and medicines will be reviewed. They will have blood tests. They will have electrocardiograms to evaluate their heart.
Participants will have imaging scans of the chest, abdomen, and pelvis. They may have a procedure where a small tube with a tiny video camera is put into the nose to look at the throat if they have head and neck cancers.
Participants will get bintrafusp alfa through an intravenous catheter. For this, a small tube is put into an arm vein. They will get BN-CV301 vaccines as injections in the arm or thigh. They will take SX-682 by mouth twice a day. They will take the study drugs up to 2 years. They will keep a medicine diary.
Participants will have study visits every 2 weeks. They will have 1 or 2 follow-up visits within 30 days after they stop treatment. Then they will be monitored by phone or email for 2 years.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06228053 — Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer
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NCT06149481 — Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-80
· Phase 1, PHASE2
· recruiting
NCT04477343 — A Study to Evaluate the Safety and Tolerability of SX-682 in Combination With Nivolumab as a Maintenance Therapy in Pati
· Phase 1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04574583.