SAR445877 for Advanced Cancer

Recruiting at 44 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Brain metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

542 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and assess the safety and effectiveness of SAR445877, an experimental treatment, for individuals with advanced cancers that cannot be removed or have metastasized. The study will evaluate this treatment both alone and in combination with other cancer therapies. It targets those with advanced cancers such as lung, melanoma, or colorectal cancer who lack better standard treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on ongoing corticosteroid therapy or have certain health conditions, you may not be eligible to participate. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SAR445877 remains under evaluation for safety and effectiveness in treating advanced solid tumors. So far, studies have not provided specific details on patient tolerance. This treatment is in early testing stages, focusing on dose determination and side effect monitoring.

Regarding its combination with other drugs like ADG126, bevacizumab, and cetuximab, clear safety information for these combinations is not yet available. Researchers are studying these drugs together to assess their potential in fighting cancer more effectively.

Since SAR445877 is in early testing, scientists continue to learn about its safety in humans. This phase of research involves closely monitoring for negative effects, though specific details on these effects have not been shared.

Prospective trial participants should discuss potential risks and benefits with health professionals, who may have more detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about SAR445877 because it offers a fresh approach to treating advanced cancers, particularly those like non-small cell lung cancer and colorectal cancer. Unlike many current treatments that often involve chemotherapy or targeted therapies focusing on well-known cancer pathways, SAR445877 is being explored for its potential to work differently, perhaps targeting unique pathways or mechanisms within different cancer types. This could lead to more effective treatments with potentially fewer side effects. Additionally, SAR445877 is being tested both as a standalone treatment and in combination with other drugs such as ADG126, bevacizumab, and cetuximab, which could enhance its effectiveness and offer new hope for patients with these difficult-to-treat cancers.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research shows that SAR445877, which participants in this trial may receive, has promising effects against tumors when used alone in patients with advanced solid tumors, such as non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Early studies found that the treatment is generally safe, and some patients experienced partial tumor shrinkage. This trial will test SAR445877 in various treatment arms, including combinations with other drugs. When combined with ADG126, SAR445877 kept CRC tumors under control for an average of 8 months, suggesting it might improve treatment outcomes. Additionally, when used with bevacizumab, SAR445877 may help better control tumors. While these findings are encouraging, more research is needed to confirm how well SAR445877 works for different types of advanced cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that can't be surgically removed or have spread, and who lack suitable standard treatments. Specific groups include those with certain types of lung, stomach, liver cancers, and gastroesophageal junction adenocarcinoma. Participants must have measurable disease and give informed consent.

Inclusion Criteria

I have advanced cancer with no standard treatment options left.

I have advanced liver cancer that cannot be removed by surgery.

Measurable Disease: At least 1 measurable lesion per RECIST 1.1 criteria

Exclusion Criteria

My daily activity is limited due to my health condition.

Predicted life expectancy ≤3 months

I am on continuous corticosteroid therapy for a health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dose Escalation

Finding the therapeutic dose(s) of SAR445877 in monotherapy and in combination with other anticancer therapies

Up to 2 years

Every 2 weeks or weekly

Dose Expansion/Optimization

Assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until disease progression or start of new anticancer therapy

What Are the Treatments Tested in This Trial?

Interventions

• SAR445877

Trial Overview

SAR445877 is being tested as a solo treatment for various advanced cancers. The trial has two parts: the first to find the best dose given every week or every other week; the second to test safety and early results at two dose levels in specific cancer types.

How Is the Trial Designed?

Group I: SAR445877 Japan Cohort F Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with advanced unresectable or metastatic solid tumor, from Japan.

Group II: SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with cetuximab in participants with colorectal cancer.

Group III: SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC).

Group IV: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC).

Group V: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously IV in participants with immune infiltrated tumor type.

Group VI: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).

Group VII: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ).

Group VIII: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with hepatocellular carcinoma (HCC).

Group IX: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC).

Group X: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC).

Group XI: SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC.

Group XII: SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC.

Group XIII: SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C) Experimental Treatment 2 Interventions

The Standard of Care (nivolumab and ipilimumab) will be administered intravenously in participants with metastatic melanoma.

Group XIV: SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma.

Group XV: SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma.

Group XVI: SAR445877 Escalation Phase (Part1B) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with ADG126 in participants with advanced unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC); renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), colorectal cancer (MSIH/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC).

Group XVII: SAR445877 Escalation Phase (Part 1C) Experimental Treatment 2 Interventions

SAR445877 will be administered intravenously in combination with bevacizumab in participants with metastatic colorectal cancer (CRC).

Group XVIII: SAR445877 Escalation Phase (Part 1A) Experimental Treatment 1 Intervention

SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

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Trials Today

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other ...

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NCT02744287: Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors. Feb 2023 - Feb 2023: Early P1 ...