Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Feb 24, 2027
  • participants needed
    456
  • sponsor
    Sanofi
Send
Updated on 3 December 2024
See if I qualify
Accepts healthy volunteers

Summary

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.

Description

Estimated Study Duration:

Dose Escalation (Part 1): Approximately 34 months Dose Optimization/Expansion (Part 2): Approximately 28 months

Details
Condition Cancer, Neoplasm,tumores sólidos
Age 18years or above
Treatment Cetuximab, carboplatin, Pembrolizumab, Pemetrexed, SAR444881
Clinical Study IdentifierNCT04717375
SponsorSanofi
Last Modified on3 December 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
US Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.