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Clinical Trials/NCT05162755
NCT05162755CompletedPhase 1

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 enrollmentStarted: October 15, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
41
Locations
9
Primary Endpoint
Adverse Events (AEs) (Dose escalation part)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Arms & Interventions

Dose escalation 1b: S95029 and Sym021

Experimental

Intervention: S95029 and Sym021 (Drug)

Dose escalation 1a: S95029

Experimental

Intervention: S095029 (Drug)

Outcomes

Primary Outcomes

Adverse Events (AEs) (Dose escalation part)

Time Frame: Through study completion, up to 2 years

Incidence, severity, and relationship of AEs

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

  • Objective Response Rate(Through study completion, up to 2 years)
  • Clinical Benefit Rate (CBR)(Through study completion, up to 2 years)
  • Duration of response (DOR)(Through study completion, up to 2 years)
  • Progression Free Survival (PFS)(Through study completion, up to 2 years)
  • Overall Survival (OS)(Through study completion, up to 2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

Loading locations...

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