542 Participants Needed

SAR445877 for Advanced Cancer

Recruiting at 36 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.14678

Who Is on the Research Team?

CS

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
See 3 more

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.
See 9 more

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?
18Treatment groups
Experimental Treatment
Group I: SAR445877 Japan Cohort FExperimental Treatment1 Intervention
Group II: SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B)Experimental Treatment2 Interventions
Group III: SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A)Experimental Treatment1 Intervention
Group IV: SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B)Experimental Treatment1 Intervention
Group V: SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A)Experimental Treatment1 Intervention
Group VI: SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A)Experimental Treatment1 Intervention
Group VII: SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A)Experimental Treatment1 Intervention
Group VIII: SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A)Experimental Treatment1 Intervention
Group IX: SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A)Experimental Treatment1 Intervention
Group X: SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A)Experimental Treatment1 Intervention
Group XI: SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D)Experimental Treatment2 Interventions
Group XII: SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D)Experimental Treatment2 Interventions
Group XIII: SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C)Experimental Treatment2 Interventions
Group XIV: SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C)Experimental Treatment2 Interventions
Group XV: SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C)Experimental Treatment2 Interventions
Group XVI: SAR445877 Escalation Phase (Part1B)Experimental Treatment2 Interventions
Group XVII: SAR445877 Escalation Phase (Part 1C)Experimental Treatment2 Interventions
Group XVIII: SAR445877 Escalation Phase (Part 1A)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

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

Citations

ADG126 Exhibits Clinical Meaningful Efficacy in MSS CRCPatients demonstrated a median duration of response (DOR) of 8 months, and an interim median overall survival (OS) of 19.4 months after 18 ...
A First-in-human, Dose Escalation and Dose Expansion ...This study investigates the safety and preliminary effects of SAR445877, an investigational medication, in adults with advanced solid tumors.
Montefiore Medical Center-Einstein Campus TrialsJan 2024 - Jun 2024 : Results from SRF114-101 trial for advanced solid tumors ... Unresectable, Locally Advanced, or Metastatic Liver Cancer. Recruiting. 2. 122.
Initial Results of a Phase 1b/2 Study of ADG126 (a Masked ...Here we present preliminary results from dose escalation of ADG126 in combination with pembrolizumab in patients with advanced/metastatic solid tumors including ...
Trials TodayThis 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 ...
A First-in-human, Dose Escalation and ...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 ...
ADG126 in Combination With Pembrolizumab in Patients ...This is a Phase 1b/2, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of ADG126-pembrolizumab combination ...
University of Texas MD Anderson Cancer Center Site ...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 ...
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