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OpenTrials
Completed

NCT Number: NCT05162755

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

The purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of S095029 alone and in combination with Sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations.

*The study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. The study will be stopped after completion of dose escalation parts 1a and 1b of the study.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Princess Margaret Cancer Centre, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Dose escalation part:

Inclusion criteria

  • Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies
  • Patients with a malignancy not amenable to surgical intervention
  • Patients with measurable disease and progression radiologically assessed
  • Patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment.
  • Patients with available archived tumor biopsy specimens or agree to mandatory biopsy
  • Estimated life expectancy ≥ 12 weeks
  • Adequate haematological function
  • Adequate renal function
  • Adequate hepatic function

Exclusion criteria

  • Pregnant and lactating women
  • Major surgery within 4 weeks prior to the first IMP administration or not recovered from the surgery
  • Patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first IMP administration
  • Active Hepatitis B Virus infection
  • Carriers of HIV antibodies
  • Patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first IMP administration
  • History of organ transplantation
  • History of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion
  • History of cirrhosis
  • History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
  • Treatment with systemic immunosuppressive therapy
  • Active autoimmune disease
  • Administration of a live vaccine within 28 days prior to inclusion

Treatment and study plan

S095029

Drug

S095029 will be administered via IV infusion every 2 weeks. Once the DLT evaluations period at the second dose level is completed and it is deemed as safe, the dose escalation part 1b will be initiated.

S95029 and Sym021

Drug

Sym021 will be administered at a fixed dose of 200mg. S095029 will be administered via IV infusion every 2 weeks. Once the RP2D dose of S95029 in combination with Sym21 is defined, dose expansion will begin.

Primary outcomes

  1. Adverse Events (AEs) (Dose escalation part)

    Time frame: Through study completion, up to 2 years

    Incidence, severity, and relationship of AEs

  2. Incidence of dose limiting toxicities (DLTs) (Dose escalation part)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    DLTs observed during a 28-day period

Secondary outcomes

  1. Objective Response Rate

    Time frame: Through study completion, up to 2 years

  2. Clinical Benefit Rate (CBR)

    Time frame: Through study completion, up to 2 years

    Assessment based on complete response, partial response and stable disease ≥ 6 months

  3. Duration of response (DOR)

    Time frame: Through study completion, up to 2 years

  4. Progression Free Survival (PFS)

    Time frame: Through study completion, up to 2 years

  5. Overall Survival (OS)

    Time frame: Through study completion, up to 2 years

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Dec 17, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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