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
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Solid Tumor
Age (in years)
18+
Phase
PHASE1
Participants needed
51
Est. Completion Date
Jun 19, 2025
Treatment type
INTERVENTIONAL
Sponsor
Servier
ClinicalTrials.gov identifier
NCT05162755
Study number
CL1-95029-001
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