What side effects are associated with this type of intervention?

Common cancer treatments, including chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy often causes fatigue, nausea, vomiting, hair loss, and myelosuppression (reduced blood cell counts). Targeted therapies, such as those inhibiting specific pathways like PI3K, can lead to hyperglycemia, diarrhea, and skin issues. Immunotherapy, including agents like pembrolizumab and nivolumab, may cause immune-related adverse events such as colitis, dermatitis, and thyroid dysfunction. Each treatment's side effect profile varies based on the specific agent and patient factors.

What prior FDA approvals exist?

The FDA has approved several anti-cancer agents that are similar to SAR444881, which is being studied in combination with other therapeutics for advanced solid tumors. Notable approvals include pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in various cancers such as melanoma and renal cell carcinoma. Pembrolizumab is approved for use alone or in combination with other agents like cetuximab. Another example is nivolumab, another PD-1 inhibitor, often used in combination with ipilimumab for melanoma. These approvals highlight the FDA's support for immunotherapy and combination treatments in cancer care.

What other types of research exist?

Promising alternatives to SAR444881 for cancer treatment in 2024 include: <ol> <li>Regorafenib: Shown efficacy in various sarcomas and metastatic osteosarcoma.</li> <li></li> </ol> Pembrolizumab: Demonstrated clinical efficacy in metastatic renal cell carcinoma and other advanced solid tumors. 3. Cabozantinib: Effective in advanced renal cell carcinoma and osteosarcoma. 4. Acalabrutinib: Used in chronic lymphocytic leukemia and showing promise in other cancers. 5. Lenvatinib: Combined with pembrolizumab, effective in advanced renal cell carcinoma and other solid tumors.

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Monoclonal Antibodies

SAR444881 + Standard Therapies for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Biond Biologics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy

Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 1

Must not have

Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications

Participants after solid organ or allogeneic hematopoietic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3, 6, 9, and 12 months, and up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, SAR444881, alone and with other treatments in advanced cancer patients who haven't responded to other therapies. The goal is to find the best dose and combination to treat these patients effectively.

Who is the study for?

This trial is for adults with advanced solid tumors that can't be removed by surgery or have spread, and who haven't responded to standard treatments. They must be physically able to perform daily activities (ECOG 0-1) and have proper organ function. Specific cancers like lung, breast, head and neck among others are included depending on the study part.

What is being tested?

The trial tests SAR444881 alone and in combinations with pembrolizumab, cetuximab, carboplatin, or pemetrexed. It has two parts: dose escalation to find safe levels of SAR444881 (alone/with drugs), then dose optimization/expansion where effective doses are given more widely. Part of the second phase involves random selection for treatment groups.

What are the potential side effects?

Potential side effects include those common to cancer therapies such as immune reactions due to pembrolizumab or cetuximab; blood count changes from carboplatin/pemetrexed; fatigue; liver function changes; skin reactions; digestive issues like nausea/vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cannot be removed by surgery and does not respond to standard treatments.

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I am fully active or can carry out light work.

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My cancer type is listed among the specified types for this trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on steroids or other drugs that suppress my immune system.

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I have had a solid organ or bone marrow transplant.

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I have hepatitis B or C, or both, and if I have liver cancer, it's untreated.

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I have an autoimmune disease.

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I have had a severe reaction to previous immune therapy.

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My cancer has spread to my brain or the lining around my brain.

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I have had severe reactions to cetuximab or similar medications before.

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I have previously received treatments that activate macrophages or NK cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3, 6, 9, and 12 months, and up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3, 6, 9, and 12 months, and up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3, 6, 9, and 12 months, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Incidence of treatment-emergent adverse events (TEAEs) dose limiting toxicities (DLT)

Part 2: Objective Response Rate (ORR) per RECIST v1.1

Secondary study objectives

PFS rate

Part 1: Objective Response Rate (ORR) per RECIST v1.1

Part 2: Duration of Response

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: SAR444881 in Combination with Pembrolizumab Dose Escalation (Sub-Part 1B)Experimental Treatment2 Interventions

Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 and pembrolizumab will be administered intravenously (IV), every 3 weeks (Q3W).

Group II: SAR444881 in Combination with Cetuximab Dose Escalation (Sub-Part 1C)Experimental Treatment2 Interventions

Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 and cetuximab will be administered intravenously (IV), every 2 weeks (Q2W).

Group III: SAR444881 Dose Optimization (Sub-Part 2A)Experimental Treatment5 Interventions

SAR444881 Dose Optimization in combination with pembrolizumab/carboplatin/pemetrexed, pembrolizumab, or cetuximab. The indication for the combination cohorts will be non-squamous non-small cell lung cancer (NSCLC), gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), colorectal carcinoma (CRC) any RAS. Enrollment will start after the recommended dose(s) of SAR444881 have been determined based on data from Sub-Parts 1A, 1B, and 1C.

Group IV: SAR444881 Dose Expansion (Sub-Part 2B)Experimental Treatment1 Intervention

The indication for this monotherapy cohort is cholangiocarcinoma. Enrollment will be opened based on emerging data from the dose-escalation phase and combination optimization data.

Group V: SAR444881 Dose Escalation (Sub-Part 1A)Experimental Treatment1 Intervention

Standard "3 + 3" dose escalation design with enrollment of at least 3 participants per dose level cohort. SAR444881 will be administered intravenously (IV), every 2 weeks (Q2W).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550

Pembrolizumab

2017

Completed Phase 3

~3150

Cetuximab

2011

Completed Phase 3

~2480

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include immunotherapy and targeted therapy. Immunotherapy, such as pembrolizumab, works by enhancing the body's immune system to recognize and attack cancer cells. Targeted therapy, like cetuximab, involves drugs designed to target specific molecules involved in cancer cell growth and survival, such as the epidermal growth factor receptor (EGFR). These treatments are significant for cancer patients because they offer more personalized and potentially more effective options with fewer side effects compared to traditional chemotherapy, improving both survival rates and quality of life.

Current status of molecular-targeted drugs for endometrial cancer (Review).