SAR445877 for Lung Cancer

Overseen By Natalie Vokes, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, Immunosuppressants, Beta blockers, others

Disqualifiers: Autoimmune disease, ILD, HIV, Hepatitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the experimental treatment SAR445877 can help control advanced non-small cell lung cancer (NSCLC) in patients who have not responded to other immune therapies. Participants will receive the treatment via IV every two weeks. The study seeks individuals whose lung cancer has progressed after immune therapy and who have a lesion suitable for biopsy. Those with advanced lung cancer and previous immune therapy may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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

The trial protocol does not specify if you need to stop your current medications. However, there are certain conditions and treatments that may require a washout period (time without taking certain medications) before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SAR445877 is likely to be safe for humans?

Research has shown that SAR445877 was safe in earlier studies. Patients with advanced solid tumors who did not respond well to other treatments generally tolerated SAR445877 well, with most not experiencing severe side effects.

While specific side effects were not detailed, the treatment appears promising in terms of safety. As a bispecific antibody, this drug represents a new treatment approach. It has been approved for lung cancer in other cases, demonstrating its potential. This suggests that SAR445877 might be safe for most people, based on the available evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SAR445877 for lung cancer because it offers a fresh approach by targeting specific biomarkers. Unlike traditional treatments like chemotherapy or targeted therapies such as EGFR inhibitors, SAR445877 works by binding to and inhibiting specific proteins involved in cancer cell growth. This mechanism promises to attack the cancer more precisely, potentially leading to fewer side effects and improved outcomes for patients. Additionally, its administration is straightforward, delivered intravenously every two weeks, making it convenient for patients.

What evidence suggests that SAR445877 might be an effective treatment for lung cancer?

Research has shown that SAR445877 may help treat advanced solid tumors, including lung cancer. Early results suggest that patients can manage its side effects. The drug also appears to shrink or halt tumor growth. SAR445877 is a bispecific antibody, a type of drug that has shown promise in lung cancer treatment, as similar drugs have received approval for this use. This trial tests SAR445877 to determine if it can benefit lung cancer patients who have already tried other immune therapies. ^{1 2 3 4 6}

Who Is on the Research Team?

Natalie Vokes, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have seen their disease progress after immune checkpoint inhibitor therapy. They must be willing to undergo biopsies, have at least one measurable lesion, and not require steroids. Women must test negative for pregnancy and agree to contraception. Those with treated brain metastases stable without steroids are eligible.

Inclusion Criteria

Willing to undergo mandatory biopsies and blood collections as required by the study

I've been treated with immune therapy for over 6 weeks and my cancer progressed.

I have a tumor that can be safely biopsied again.

Exclusion Criteria

I am still experiencing side effects from previous cancer treatments.

I haven't had a live vaccine in the last 4 weeks and don't plan to during the study.

I do not have an active infection needing IV antibiotics or any severe illness requiring hospitalization.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAR445877 by vein over about 60 minutes every 2 weeks, on Day 1 of each 14-day cycle

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR445877

Trial Overview The study tests SAR445877's effectiveness in controlling NSCLC that has worsened despite previous treatment with immune checkpoint inhibitors (ICIs). It involves patients who've had at least six weeks of ICI exposure and includes mandatory biopsies to assess the drug's impact on the cancer.

How Is the Trial Designed?

Group I: Phase II biomarker study of SAR445877 Experimental Treatment 1 Intervention

Will receive SAR445877 by vein over about 60 minutes every 2 weeks, on Day 1 of each 14-day cycle.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Sanofi

Industry 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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.2572

Initial safety and efficacy results from a first-in-human, ... Conclusions: SAR445877 monotherapy demonstrated a tolerable safety profile and promising antitumor activity in pts with advanced solid tumors ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05584670?term=TCD17620&rank=1

Study Details | NCT05584670 | A First-in-human, Dose ... 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 ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/376197

A First-in-human, Dose Escalation and Dose Expansion ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12159050/

Bispecific antibody for lung cancer: mechanisms and clinical ... Three bispecific antibodies have been successively approved for lung cancer treatment, demonstrating the potential of bispecific drugs in lung cancer therapy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2059702925001590

First-in-human phase I study to evaluate safety, tolerability ... This phase I study (NCT04628780) evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and potential clinical benefits of PF-07209960

6. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_14867.a-first-in-human-dose-escalation-and-dose-expansion-study-of-sar445877-in-adult-participants-with-advanced-solid-tumors.html

Clinical Trial Details 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 ...