RecruitingPhase 2

Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of SR-8541A pills with botensilimab and balstilimab, given through a vein. It is for adults with colon or rectal cancer that has spread and has already been treated with chemotherapy. The cancer must have a test result called microsatellite stable (MSS); people with or without cancer in the liver may qualify.

This is an open-label, dose escalation and expansion, multi-center phase 2 study evaluating the safety and efficacy of SR-8541A administered orally in combination with intravenous botensilimab and balstilimab in subjects with MSS-CRC with and without active liver metastases.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, sign a consent form, and be able to follow the study schedule.
  • Have adenocarcinoma, a type of colon or rectal cancer, confirmed by a tissue test. It must have spread and cannot be removed by surgery.
  • Have tumor test results showing non-MSI-H or non-dMMR, which describe how cancer cells repair DNA.
  • Have had at least one chemotherapy treatment plan for cancer that spread or came back.
  • Be fully active or able to do light work, and have cancer that can be measured on scans.
  • Provide a stored or new tumor sample before treatment. A sample after treatment is optional.
  • Have good enough kidney, liver, and blood function. Have no blood cell growth medicines, transfusions, or albumin infusions within 14 days before treatment.
  • If able to have children, use highly effective birth control and avoid sperm or egg donation during treatment and for at least 3 months after. Birth control pills must start at least 14 days before treatment.

Who can't join

  • Allergy to study drugs or their ingredients. Active cancer in the liver rules out joining Part 2, Cohort A only.
  • Past treatment with immune checkpoint drugs or experimental immune treatments; recent cancer treatment or another study drug; or use of medicines the study does not allow.
  • A recent or developing bowel blockage, belly fluid that does not respond to treatment, or gut problems that could keep the study pills from being absorbed.
  • Certain lung inflammation, an immune disease needing whole-body treatment in the past 2 years, recent immune-suppressing medicines, adrenal or pituitary gland failure, or a past donor organ, stem cell, or bone marrow transplant.
  • Certain serious heart problems, uncontrolled high blood pressure, abnormal heart tests, or a bleeding problem that cannot be quickly reversed.
  • Uncontrolled brain or nerve disease, cancer in the lining around the brain or spinal cord, or spinal cord pressure not fully treated. Previously treated, stable brain tumors may be allowed.
  • An active infection needing whole-body treatment, HIV, active hepatitis B or C, or recent COVID-19. Pregnancy or plans to breastfeed during treatment or within 3 months afterward also rule out joining.
  • Recent surgery, certain other cancers, or another illness, test finding, mental health condition, or substance use problem that the study doctor believes could affect safety or study participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Written informed consent from subject 2. Age ≥ 18 years old on the date of consent 3. Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum 4. Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method 5. Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 7. Measurable disease per RECIST v1.1 (Eisenhauer et al., 2009) 8. Able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional) 9. Adequate renal function defined as creatinine clearance ≥ 60mL/min 10. Adequate liver function 11. Adequate hematologic function 12. No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment 13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 14. Male and female subjects of childbearing potential must agree to use a highly medically effective method of contraception and refrain from sperm/egg donation throughout the study starting with the first dose of study treatment (or 14 days prior to the first dose of study treatment for oral contraception) and for at least 3 months after the last dose of study treatment Exclusion Criteria: 1. Hypersensitivity or allergy to any of the study drugs or their excipients. 2. In Part 2, Cohort A, active liver metastases by computed topography (CT) or magnetic resonance imaging (MRI). 3. Treatment with one of the following classes of drugs within the delineated time window prior to first dose: 1. Small molecule/tyrosine kinase inhibitors within 2 weeks 2. Any other systemic therapy for CRC within 3 weeks 3. Received another investigational drug within 30 days or active participation in another clinical trial (follow-up is permitted) 4. Medications/products which are known strong inhibitors or inducers of the CYP enzymes within 5 x T1/2 4. Received programmed cell death protein 1, PD-(L)1, or CTLA-4 therapies including any immune checkpoint inhibitor or experimental immunologic agents. 5. Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction. 6. Refractory ascites. 7. Current evidence of interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids. 8. Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days prior to Day 1. 9. Active autoimmune disease that has required systemic treatment in past 2 years 10. Patients with adrenal / pituitary insufficiency 11. History of documented congestive heart failure; unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class \> 2 12. History of allogeneic organ transplant, stem cell transplant, or bone marrow transplant 13. Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to first dose 14. Requirement for treatment with strong cytochrome P450 3A4 inducers or inhibitors 15. Presence of gastrointestinal condition, for example, malabsorption, that might affect the absorption of Investigational Product(s). 16. Troponin I \> ULN 17. Uncontrolled hypertension 18. Corrected QT interval by Fridericia (QTcF) ≥ 470 ms per the central mean average of triplicate electrocardiograms (ECGs) 19. Left Ventricular Ejection Fraction (LVEF) \< 50% using echocardiogram or multigated acquisition (MUGA) 20. Symptomatic uncontrolled central nervous system (CNS) disease requiring treatment with steroids or anti-seizure medications within 2 months prior to Day 1. However, subjects with brain metastases that have been previously treated and are stable based on imaging performed within 2 months of Day 1 following completion of any CNS-directed therapy are allowed 21. Leptomeningeal disease 22. Spinal cord compression not definitively treated with surgery and/or radiation 23. Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment 24. Prior additional malignancy that is progressing or has received treatment the previous 3 years prior to first dose except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast 25. History of uncontrolled seizures, central nervous disorders, substance abuse disorder or psychiatric disability judged by the Investigator to be clinically significant and would interfere with cooperation with requirements of the study 26. Active infection requiring systemic treatment at time of first dose 27. Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitis B (e.g., HbsAg reactive) or active hepatitis C (e.g., HCV ribonucleic acid \[RNA\] qualitative) infection with detectable viral load 28. Pregnant or lactating females who plan to nurse a child during or within 3 months of the last dose of study treatment 29. Major surgery within 28 days prior to first dose and/or minor surgery (excluding biopsy) within 7 days prior to first dose. Note: If the subject had major surgery, the subject must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention 30. Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject or impair the assessment of study results 31. Planned use of any of the prohibited concomitant medications

Study sites (6)

NJ

TX

WA