S095029 + Sym021 for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byNehal Lakhani MD, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Institut de Recherches Internationales Servier

No Placebo Group

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.

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

Patients with skin rash of Grade > 1 from prior anti-EGFR

You have a major problem with your digestive system.

Patients with available archived tumor biopsy specimens or agree to mandatory biopsy

+13 more

Exclusion Criteria

You have a past history of liver disease called cirrhosis.

You are currently pregnant or breastfeeding.

Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration

+10 more

Participant Groups

The study tests S095029 alone and combined with Sym021 in patients with various solid tumors. It will expand to test triple combinations involving anti-HER2 therapy (futuximab/modotuximab) specifically in those with metastatic gastric or colorectal cancers.

2Treatment groups

Experimental Treatment

Group I: Dose escalation 1b: S95029 and Sym021Experimental Treatment1 Intervention

Group II: Dose escalation 1a: S95029Experimental Treatment1 Intervention

S095029 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Libtayo for:

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

🇪🇺 Approved in European Union as Libtayo for: