51 Participants Needed

S095029 + Sym021 for Colorectal Cancer

Recruiting at 4 trial locations
Id
Overseen ByInstitut de Recherches Internationales Servier, Clinical Studies Department
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Institut de Recherches Internationales Servier
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The research shows that combining different drugs, like cetuximab with chemotherapy, can be effective for certain types of colorectal cancer. Additionally, combining immune therapies with other targeted treatments has shown promise in improving response rates in similar cancer types.12345

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?

The drug combination of S095029 and Sym021 (cemiplimab) is unique because it includes cemiplimab, a PD-1 antibody that helps the immune system recognize and attack cancer cells, which is a different approach compared to traditional chemotherapy drugs used for colorectal cancer.37111213

Research Team

NL

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

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
See 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
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation 1a

Participants receive S095029 as monotherapy to assess safety and tolerability

4 weeks
1 visit per week (in-person)

Dose Escalation 1b

Participants receive S095029 in combination with Sym021 to assess safety and tolerability

4 weeks
1 visit per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

  • anti-HER2 therapy
  • futuximab/modotuximab
  • S095029
  • Sym021
Trial OverviewThe 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.
Participant Groups
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:
  • 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

Trials
91
Recruited
67,100+

ADIR, a Servier Group company

Industry Sponsor

Trials
33
Recruited
4,300+

Findings from Research

In a phase II trial involving 35 patients with untreated metastatic colorectal cancer, the combination of gefitinib, capecitabine, and oxaliplatin resulted in an 80% disease control rate, with 8.6% achieving a complete response and 40% a partial response.
The treatment led to a median overall survival of 21.9 months, which is promising compared to previous regimens, and the side effects were manageable, primarily consisting of diarrhea and vomiting.
A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer.Gelibter, AJ., Gamucci, T., Pollera, CF., et al.[2018]
Cemiplimab (Libtayo®) is the first approved immunotherapy for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who cannot undergo surgery or radiotherapy, showing a clinically significant objective response rate in the phase II EMPOWER-CSCC 1 trial.
The treatment has a durable effect, with the median duration of response and overall survival not yet reached, and it has an acceptable safety profile, with manageable immune-related adverse events.
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma.Lee, A., Duggan, S., Deeks, ED.[2020]
Cemiplimab, administered as monotherapy or in combination with hypofractionated radiation therapy, showed a 10% objective response rate in patients with recurrent or metastatic cervical cancer, particularly in those with squamous histology, indicating its potential efficacy in this subgroup.
The most common side effects were diarrhea, fatigue, and hypokalemia, affecting 35%, 25%, and 25% of patients respectively, suggesting that while cemiplimab has anti-tumor activity, it also has a manageable safety profile.
PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer.Rischin, D., Gil-Martin, M., González-Martin, A., et al.[2021]

References

Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer. [2023]
Overall Survival, BRAF, RAS, and MSI Status in Patients Who Underwent Cetuximab After Refractory Chemotherapy for Metastatic Colorectal Cancer. [2023]
A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer. [2018]
Efficacy and Tolerability of First-Line Cetuximab Plus Leucovorin, Fluorouracil, and Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 in Patients With RAS Wild-Type Metastatic Colorectal Cancer: The Open-Label, Randomized, Phase III TAILOR Trial. [2023]
Combined PD-1, BRAF and MEK inhibition in BRAFV600E colorectal cancer: a phase 2 trial. [2023]
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]
PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer. [2021]
Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]
Cemiplimab: First Global Approval. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low-dose Cyclophosphamide in Patients with Advanced Malignancies. [2021]
[Efficacy of cetuximab in therapy of metastatic colorectal cancer: a system evaluation]. [2015]
Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies. [2023]
Cetuximab versus bevacizumab following prior FOLFOXIRI and bevacizumab in postmenopausal women with advanced KRAS and BRAF wild-type colorectal cancer: a retrospective study. [2021]