Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)Phase 2NCT06589440
Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
A Phase 2 study testing SR-8541A in people with Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC), run by Stingray Therapeutics at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
- What is being tested?
- SR-8541A
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Nov 2024to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent from subject
- Age ≥ 18 years old on the date of consent
- Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum
- Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method
- Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
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- Measurable disease per RECIST v1.1 (Eisenhauer et al., 2009)
- Able to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
- Adequate renal function defined as creatinine clearance ≥ 60mL/min
- Adequate liver function
- Adequate hematologic function
- No growth factor support, transfusions, or albumin administration within 14 days of first dose of study treatment
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- 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
Who cannot join
- Hypersensitivity or allergy to any of the study drugs or their excipients.
- In Part 2, Cohort A, active liver metastases by computed topography (CT) or magnetic resonance imaging (MRI).
- Treatment with one of the following classes of drugs within the delineated time window prior to first dose:
- Small molecule/tyrosine kinase inhibitors within 2 weeks
- Any other systemic therapy for CRC within 3 weeks
- Received another investigational drug within 30 days or active participation in another clinical trial (follow-up is permitted)
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- Medications/products which are known strong inhibitors or inducers of the CYP enzymes within 5 x T1/2
- Received programmed cell death protein 1, PD-(L)1, or CTLA-4 therapies including any immune checkpoint inhibitor or experimental immunologic agents.
- Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
- Refractory ascites.
- Current evidence of interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.
- Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days prior to Day 1.
- Active autoimmune disease that has required systemic treatment in past 2 years
- Patients with adrenal / pituitary insufficiency
- 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
- History of allogeneic organ transplant, stem cell transplant, or bone marrow transplant
- Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to first dose
- Requirement for treatment with strong cytochrome P450 3A4 inducers or inhibitors
- Presence of gastrointestinal condition, for example, malabsorption, that might affect the absorption of Investigational Product(s).
- Troponin I > ULN
- Uncontrolled hypertension
- Corrected QT interval by Fridericia (QTcF) ≥ 470 ms per the central mean average of triplicate electrocardiograms (ECGs)
- Left Ventricular Ejection Fraction (LVEF) < 50% using echocardiogram or multigated acquisition (MUGA)
- 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
- Leptomeningeal disease
- Spinal cord compression not definitively treated with surgery and/or radiation
- Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment
- 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
- 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
- Active infection requiring systemic treatment at time of first dose
- 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
- Pregnant or lactating females who plan to nurse a child during or within 3 months of the last dose of study treatment
- 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
- 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
- Planned use of any of the prohibited concomitant medications
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Texas Oncology- Austin
Austin, Texas, 78745
Marian Heaven, 1-888-864-4226, marian.heaven@usoncology.com
- Recruiting
Texas Oncology- Sammons- DFW
Dallas, Texas, 75246
Christine Terraciano, 1-888-864-4226, Christine.Terraciano@usoncology.com
- Recruiting
The University of Texas M.D. Anderson Cancer Center GI Medical Oncology Dept
Houston, Texas, 77030
GI Medical Oncology Dept, 713-745-0774, GIClinicalTrials@mdanderson.org
- Recruiting
Atlantic Health
Morristown, New Jersey, 07960
Nancy Ginder, 973-971-6608, Nancy.ginder@atlantichealth.org
- Recruiting
Swedish
Seattle, Washington, 98104
Gold, (206)215-2121, Philip.Gold@swedish.org
- Recruiting
Texas Oncology- Northeast Texas
Tyler, Texas, 75702
Jennifer Castner, 903-579-9800, jennifer.castner@usoncology.com
About this study
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.
- Being tested
- SR-8541A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-8541ADrug
Also called Botensilimab, Balstilimab
SR-8541A administered orally in combination with intravenous botensilimab and balstilimab
| Study group | Role | What they receive |
|---|---|---|
| MSS-CRC subject with no active liver metastases | Experimental | Not described Receives: Drug: SR-8541A |
| MSS-CRC subject with active liver metastases | Experimental | Not described Receives: Drug: SR-8541A |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab
Part 1 of the study is to establish the recommended dose of SR-8541A in combination with botensilimab and balstilimab.
Measured: Approximately 3 dose levels (DL) will be investigated in 28-day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Nov 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 will follow a traditional 3+3 dose escalation scheme. Approximately 6-12 subjects will be treated in Part 1. Part 2 Approximately up to 58 subjects will be enrolled: Cohort A: MSS-CRC subject with no active liver metastases Cohort B: MSS-CRC subject with active liver metastases
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stingray Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589440
- Sponsor's protocol ID
- SR-8541A-002
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)
- ClinicalTrials.gov ID
- NCT06589440
- Acronym / sponsor ID
- SR-8541A-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Stingray TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1 will follow a traditional 3+3 dose escalation scheme. Approximately 6-12 subjects will be treated in Part 1. Part 2 Approximately up to 58 subjects will be enrolled: Cohort A: MSS-CRC subject with no active liver metastases Cohort B: MSS-CRC subject with active liver metastases
| Arm | Type | Receives |
|---|---|---|
| MSS-CRC subject with no active liver metastases | Experimental | Drug: SR-8541A |
| MSS-CRC subject with active liver metastases | Experimental | Drug: SR-8541A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent from subject
- Age ≥ 18 years old on the date of consent
- Histologically confirmed diagnosis of unresectable and metastatic adenocarcinoma of the colon or rectum
- Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non-dMMR) tumor status per a standard local testing method
- Must have received at least 1 prior chemotherapy regimen for metastatic or recurrent CRC
Key exclusion criteria (35 listed)
- Hypersensitivity or allergy to any of the study drugs or their excipients.
- In Part 2, Cohort A, active liver metastases by computed topography (CT) or magnetic resonance imaging (MRI).
- Treatment with one of the following classes of drugs within the delineated time window prior to first dose:
- Received programmed cell death protein 1, PD-(L)1, or CTLA-4 therapies including any immune checkpoint inhibitor or experimental immunologic agents.
- Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR-8541AAlso: Botensilimab, BalstilimabSR-8541A administered orally in combination with intravenous botensilimab and balstilimab | Drug | MSS-CRC subject with active liver metastases, MSS-CRC subject with no active liver metastases |
Primary outcome
To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab
Time frame: Approximately 3 dose levels (DL) will be investigated in 28-day cycles
Part 1 of the study is to establish the recommended dose of SR-8541A in combination with botensilimab and balstilimab.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR-8541A in people with Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC), run by Stingray Therapeutics at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunil Sharma, MD (602-343-8402, ssharma@honorhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety, tolerability, efficacy, and define the optimal dose for expansion of SR-8541A in combination with botensilimab and balstilimab (time frame: Approximately 3 dose levels (DL) will be investigated in 28-day cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.