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S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers

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Servier Protocol Code: CL1-95029-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT05162755

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 5 locations

Study description

This study is needed to test a new drug, called S095029, alone or in combination with other drugs, in patients with advanced solid tumors. In advanced stages of the disease, solid tumors may spread to other parts of the body.

An antibody is a protein in the blood that helps the body’s immune system by identifying and attaching to specific threats, including cancer cells. S095029 contains an antibody that could help immune system fight cancer cells. This study is the first to test S095029 in humans.

Sym021 is another drug that contains an antibody that helps the immune system fight cancer cells. Sym021 has been tested alone and in different combinations with other antibodies in clinicals trials, and has been shown to be safe.

Based on previous studies, scientists expect the study drug to work better in combination with other treatments. This study tests S095029 alone and in combination with Sym021, as well as in combination with other drugs called S095026 and margetuximab. S095026 contains two antibodies (futuximab and modotuximab) that help the immune system fight cancer. Margetuximab also contains an antibody and has been approved for the treatment of several cancers.

The study is split into two parts. The main goals of the study are:

Part 1:

  • To assess how safe and well-tolerated S095029 is, alone or in combination with Sym021.
  • To find the maximum tolerated dose (MTD) of S095029, alone or in combination with Sym021. The MTD is the highest dose of the drug that can be taken without causing too severe side effects.

Part 2:

  • To test how well the combination of S095029, Sym021 and margetuximab works. This part of the study includes participants with a specific type of advanced stomach cancer (called HER2-positive) that cannot be removed by surgery or has spread to other parts of the body.
  • To test how well the combination of S095029, Sym021 and S095026 works. This part of the study includes participants with colon cancer that has spread to other parts of the body.
Official title: A Phase 1a/1b, Open-label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Anti-neoplastic Activity of S095029 (Anti-NKG2A) as Monotherapy and in Combination With Sym021 (Anti-PD-1) in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triplet Combinations of S095029 and Sym021 and an Anti-HER2 mAb or Anti-EGFR mAbs (Futuximab/Modotuximab) in Patients With Metastatic Gastric or Colorectal Cancers
Conditions
Solid Tumor
Interventions / Treatments
  • S095029
  • S95029 and Sym021
Other study id numbers
  • CL1-95029-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged 18 or older.
  • Have advanced solid tumors that cannot be removed by surgery.
  • Have not responded to the previous anticancer treatments or have had side effects they couldn’t tolerate.

Participants cannot take part in the study if they:

  • Have received a similar antibody treatment in the past.
  • Have a cancer that has spread to the brain or spinal cord and has not been treated.
  • Have received treatment that suppresses their immune system.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Sequential
Participant Group / Arm
Experimental: Dose escalation 1a: S095029

Participants receive S095029 alone.

Intervention / Treatment
Drug: S095029
Participant Group / Arm
Experimental: Dose escalation 1b: S095029 and Sym021

Participants receive S095029 with Sym021.

Intervention / Treatment
Drug: S095029 + Sym021
Participant Group / Arm
Experimental: Dose expansion 2a: S095029 + Sym021 + margetuximab

Participants with advanced gastric cancer receive S095029 with Sym021 and margetuximab.

Intervention / Treatment
Drug: S095029 + Sym021 + margetuximab
Participant Group / Arm
Experimental: Dose expansion 2b: S095029 + Sym021 + S095026 (futuximab/modotuximab)

Participants with advanced colorectal cancer receive S095029 with Sym021 and S095026.

Intervention / Treatment
Drug: S095029 + Sym021 + S095026 (futuximab/modotuximab)

Keywords

Provided by Servier
Adults Advanced solid tumors Sym21 Futuximab/modotuximab Triplet combination Anti-EGFR Anti-HER2