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

NCT05162755 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CL1-95029-001
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 5

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.

Conditions

Solid Tumor

Keywords

Adults; Advanced solid tumors; Sym21; Futuximab/modotuximab; Triplet combination; Anti-EGFR; Anti-HER2

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AEs) (Dose escalation part)

  Incidence, severity, and relationship of AEs

  Through study completion, up to 2 years

• Incidence of dose limiting toxicities (DLTs) (Dose escalation part)

  DLTs observed during a 28-day period

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

Secondary Outcomes (5)

• 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

Study Arms (2)

Dose escalation 1a: S95029

EXPERIMENTAL

Drug: S095029

Dose escalation 1b: S95029 and Sym021

EXPERIMENTAL

Drug: S95029 and Sym021

Interventions

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.

Dose escalation 1a: S95029

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.

Dose escalation 1b: S95029 and Sym021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 cirrhosis
• History of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition
• Treatment with systemic immunosuppressive therapy
• Active autoimmune disease

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR, a Servier Group company: collaborator

Study Sites (5)

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

Princess Margaret Cancer Centre

Toronto, Canada

Location

Related Links

• Find Results on Servier Clinical Trial Data website

Study Officials

• Nehal Lakhani MD, MD, PhD

  Director of Clinical Research START Midwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: December 17, 2021
• Study Start: October 15, 2021
• Primary Completion: February 1, 2024
• Study Completion (Estimated): May 19, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Locations

CA (1); US (4)