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

Phase 1

Active, not recruiting

• Conditions: Solid Tumor
• Interventions: Drug: S95029 and Sym021; Drug: S095029 and Sym021 and anti-HER2 therapy; Drug: S095029

• 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-14
• Study Start: 2021-10-15
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-17
• Primary Completion: 2024-02-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Study Completion: 2025-06-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

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

Read More

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

Cohort expansion part 2a:

Inclusion Criteria:

• Histologically proven metastatic HER2+ gastric cancer
• Have received treatment with first line of standard therapy and eligible for second line

Exclusion Criteria:

Same criteria as for Part 1 with the addition of:

• Left ventricle ejection fraction < 50%

Cohort expansion part 2b:

Inclusion Criteria:

• Patients with confirmed adenocarcinoma of metastatic colorectal cancer
• Patients must have a wild-type gene status for KRAS (exons 2, 3, 4), NRAS (exons 2, 3, 4) and BRAF (absence of V600E mutation) in a tumor biopsy collected at time of screening.

Exclusion Criteria:

Same criteria as for dose escalation part with the addition of:

• Patients with a significant gastrointestinal abnormality
• Patients with skin rash of Grade > 1 from prior anti-EGFR

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation 1b: S95029 and Sym021	S95029 and Sym021	-
Dose expansion 2a: S095029 and Sym021 and anti-HER2 therapy	S095029 and Sym021 and anti-HER2 therapy	-
Dose escalation 1a: S95029	S095029	-

Primary Outcome Measures

Name	Time	Method
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
Adverse Events (AEs) (Dose escalation part)	Through study completion, up to 2 years	Incidence, severity, and relationship of AEs
Assessment of antitumor activity using RECIST v1.1 (Dose expansion part)	Through study completion, up to 2 years	Objective Response Rate

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR) (Dose escalation and dose expansion parts)	Through study completion, up to 2 years
Objective Response Rate (Dose escalation part)	Through study completion, up to 2 years
Clinical Benefit Rate (CBR) (Dose escalation and dose expansion parts)	Through study completion, up to 2 years	Assessment based on complete response, partial response and stable disease ≥ 6 months
Progression Free Survival (PFS) (Dose escalation and dose expansion parts)	Through study completion, up to 2 years
Overall Survival (OS) (Dose escalation and dose expansion parts)	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