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
- Registration Number
- NCT05162755
- Lead Sponsor
- Institut de Recherches Internationales Servier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation 1b: S95029 and Sym021 S95029 and Sym021 - Dose escalation 1a: S95029 S095029 -
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) (Dose escalation part) Through study completion, up to 2 years Incidence, severity, and relationship of AEs
Incidence of dose limiting toxicities (DLTs) (Dose escalation part) At the end of Cycle 1 (each cycle is 28 days) DLTs observed during a 28-day period
- Secondary Outcome Measures
Name Time Method Objective Response Rate Through study completion, up to 2 years Clinical Benefit Rate (CBR) Through study completion, up to 2 years Assessment based on complete response, partial response and stable disease ≥ 6 months
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
Trial Locations
- Locations (5)
The START Center for Cancer Care
🇺🇸San Antonio, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Canada
START Midwest
🇺🇸Grand Rapids, Michigan, United States