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

Institut de Recherches Internationales Servier9 sites in 2 countries41 target enrollmentOctober 15, 2021

ConditionsSolid Tumor

InterventionsS095029 S95029 and Sym021

DrugsS095029 S95029 and Sym021

Overview

Phase: Phase 1
Intervention: S095029
Conditions: Solid Tumor
Sponsor: Institut de Recherches Internationales Servier
Enrollment: 41
Locations: 9
Primary Endpoint: Adverse Events (AEs) (Dose escalation part)
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2021

End Date

May 19, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Institut de Recherches Internationales Servier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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