Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors
Investigating an Investigational Medication for Advanced Cancer
Study Overview
The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization/expansion phase (Part 2). Part 1 is comprised of three sub-parts: SAR444881 administered alone (Sub-Part 1A), SAR444881 administered in combination with pembrolizumab (Sub-Part 1B), and SAR444881 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of SAR444881 per indication are administered in combination with pembrolizumab, cetuximab, and/or carboplatin and pemetrexed (Sub-Part 2A); and a dose expansion part where SAR444881 is administered alone (Sub-Part 2B). In Sub-Part 2A, a two-stage design will be implemented to conduct dose optimization for each indication with combination therapy- Stage 1 (Preliminary Assessment) and Stage 2 (Randomization). Study is non-randomized except Stage 2 of Sub-Part 2A which will use randomization.
Study Details
Estimated Study Duration:
Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Cancer, Neoplasm
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy
- Histologic confirmation of malignancy
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1
- Participants must have adequate organ function as defined by laboratory tests
- Part 1: Following tumor types: Breast cancer, cervical cancer, colorectal cancer, adenocarcinoma or squamous cell carcinoma of the esophagus, gastric or gastroesophageal junction adenocarcinoma, squamous cell carcinoma of the head and neck, hepatobiliary cancers (hepatocellular carcinoma (HCC), gallbladder cancer, cholangiocarcinoma), non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the skin, pancreatic adenocarcinoma, ovarian cancer or urothelial carcinoma
- Part 2: Following tumor types: Squamous cell carcinoma of the head and neck, Gastric or gastroesophageal junction adenocarcinoma, non-squamous non-small cell lung cancer, non-small cell lung cancer, colorectal carcinoma (CRC) any RAS, and/or Cholangiocarcinoma
Exclusion Criteria:
- Active, known or suspected autoimmune disease
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Brain or leptomeningeal metastases
- Known history of positive test for HIV
- Non-HCC patients: acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV); HCC patients: untreated active HBV or dual infection with HBV/HCV
- Participants after solid organ or allogeneic hematopoietic stem cell transplant
- History of life-threatening toxicity related to prior immune therapy
- History of life-threatening toxicity related to prior cetuximab or other anti-EGFR antibodies (for Sub-Part 1C)
- Unstable or deteriorating cardiovascular disease within the previous 6 months
- Any major surgery within 4 weeks of study drug administration
- Prior/Concomitant Therapy:
- Cytotoxic/Non-cytotoxic anti-cancer agents, unless at least 4 weeks have elapsed from last dose
- Use of other investigational drugs within 28 days
- Prior treatment with macrophage or natural killer (NK) cells activating therapies
- Administration of a live attenuated vaccine within 28 days
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
This study investigates an investigational medication for patients with advanced cancer that cannot be removed by surgery or has spread to other parts of the body. These patients have not responded to standard treatments or are not suitable for them. The study has two parts: Part 1 focuses on finding the right dose, and Part 2 aims to optimize and expand the dose. In Part 1, the investigational medication is given alone or with other treatments like pembrolizumab and cetuximab. Part 2 involves further testing of the medication alone or in combination with other drugs.
Participants will undergo various procedures to assess the safety and effectiveness of the investigational medication. This includes regular health check-ups, blood tests, and imaging scans to measure the cancer's response to the treatment. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Who can participate: Adults with advanced cancer that cannot be removed by surgery or has spread, who have not responded to standard treatments. Participants must have a good performance status, adequate organ function, histologic confirmation of malignancy, and specific tumor types for each part of the study.
- Study Details: Participants will receive the investigational medication alone or with other treatments. They will have regular health check-ups and tests to monitor their response to the treatment. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines: The study will last approximately 62 months.
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