S095029 + Sym021 for Colorectal Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing two new drugs, S095029 and Sym021, to see if they can help treat advanced cancers. The study focuses on patients whose cancers have not responded well to other treatments. Researchers want to find out if these drugs can safely and effectively stop or slow down cancer growth.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapy, you may need to stop, as it is listed in the exclusion criteria.
What data supports the effectiveness of the drug S095029 + Sym021 for colorectal cancer?
Is the combination of S095029 and Sym021 safe for humans?
Cemiplimab (also known as Libtayo or cemiplimab-rwlc), which is part of the treatment combination, has been shown to have an acceptable safety profile in clinical trials for various cancers, including advanced cutaneous squamous cell carcinoma. Most side effects were manageable with treatment adjustments or stopping the medication.678910
How is the drug S095029 + Sym021 different from other colorectal cancer treatments?
Research Team
Nehal Lakhani MD, MD, PhD
Principal Investigator
Director of Clinical Research START Midwest
Eligibility Criteria
This trial is for adults with advanced solid tumors, including metastatic HER2+ gastric and colorectal cancers. Participants must have tried standard treatments without success or be intolerant to them. They need good heart, liver, kidney, and blood function and can't have had major surgery recently or suffer from active infections or certain chronic conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation 1a
Participants receive S095029 as monotherapy to assess safety and tolerability
Dose Escalation 1b
Participants receive S095029 in combination with Sym021 to assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- anti-HER2 therapy
- futuximab/modotuximab
- S095029
- Sym021
S095029 is already approved in United States, European Union for the following indications:
- Advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression and no EGFR, ALK, or ROS1 aberrations
- Advanced NSCLC in combination with platinum-based chemotherapy
- Not specified in the provided sources, but generally approved for similar indications as in the US
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institut de Recherches Internationales Servier
Lead Sponsor
ADIR, a Servier Group company
Industry Sponsor