Actively Recruiting
A Phase 12 Open Label Study to Evaluate Safety, Pharmacokinetics, and Anti-tumor Activity of SAR445877 Alone or With Other Anticancer Therapies in Adults With Advanced Solid Tumors
Led by Sanofi · Updated on 2026-01-20
542
Participants Needed
22
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SAR445877, alone or combined with other anticancer therapies, in adults with advanced unresectable or metastatic solid tumors. This Phase 12, open-label study aims to assess the safety and preliminary effectiveness of SAR445877 in various solid tumor types where standard treatments are not suitable or have failed. The study includes about 542 participants across multiple cohorts and tumor types. The study has two parts Part 1 is a dose escalation phase to find the best doses of SAR445877 given intravenously either every 2 weeks or weekly, alone or with other drugs such as cetuximab, ADG126, or bevacizumab. Part 2 is a dose expansion and optimization phase to further evaluate safety and early efficacy of SAR445877 at selected doses in monotherapy and in combination therapy across different cancer types, including non-small cell lung cancer, hepatocellular carcinoma, gastric cancer, colorectal cancer, and melanoma. Participants will undergo a screening period up to 28 days before starting treatment, which continues until disease progression, unacceptable side effects, or withdrawal. After treatment ends, there is a follow-up period until progression, new therapy, death, or withdrawal. Assessments include monitoring for side effects and tumor response using standard criteria. Researchers will also study pharmacokinetics, presence of anti-drug antibodies, and survival outcomes over up to 2 years.
CONDITIONS
Brief Title
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with advanced unresectable or metastatic solid tumors with no standard alternative therapy available or suitable
- Specific tumor types depending on study part, including melanoma, non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, colorectal cancer, gastric cancer, and others
- Measurable disease by RECIST 1.1 criteria
- Prior anticancer therapy requirements vary by cohort, generally requiring at least one prior systemic therapy
- Adequate organ function and ability to provide informed consent
You will not qualify if you...
- ECOG performance status of 2 or greater
- Life expectancy less than 3 months
- Child Pugh Class B or C liver score for hepatocellular carcinoma participants in dose expansion phase
- Other progressing malignancies requiring active treatment within 2 years
- Known active brain metastases or leptomeningeal metastases
- History of severe immune-related adverse events from prior immune therapies
- Ongoing corticosteroid therapy above specified doses
- Significant cardiac or vascular disease within 6 months
- Recent or ongoing significant autoimmune disease requiring immunosuppressive treatment
- History or evidence of interstitial lung disease or active pneumonitis within 3 years
- Organ transplant requiring immunosuppressive therapy
- Active or uncontrolled infections including HIV, hepatitis B or C, or immunodeficiency
Research Team
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