A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors.

  • STATUS
    Recruiting
  • End date
    May 11, 2029
  • participants needed
    106
  • sponsor
    Sanofi
Updated on 23 September 2022
cancer diagnosis
primary cancer

Summary

This is a single group, treatment, Phase 1/Phase 2, open label, multiple cohort, first-in-human study to evaluate safety and efficacy of SAR444200 as a monotherapy or in combination with other anti-cancer agents for participants aged at least 18 years with previously treated metastatic malignancies.

Description

Treatment Period: enrolled participants will receive continuous treatment until disease progression (PD), unacceptable adverse event (AE), or other permanent discontinuation criteria.

The End of Treatment visit will occur 30 days ±7 days from last IMP administration or prior to initiation of further therapy, whichever occurs first.

Details
Condition Neoplasm
Treatment Cemiplimab, SAR444200
Clinical Study IdentifierNCT05450562
SponsorSanofi
Last Modified on23 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cancer diagnosis for participants for Part 1A and Part 1B
Metastatic and/or unresectable HCC diagnosed by histology and/or cytology, or diagnosed clinically by the American Association for the Study of Liver Diseases (AASLD) criteria for participants with liver cirrhosis (participants without liver cirrhosis must be diagnosed histologically) OR Other histology/cytology proven advanced and/or metastatic non-HCC solid tumors
Not amenable to available standard of care: participants must have experienced disease progression on/after standard of care, or no acceptable standard curative or palliative treatments exist (or are no longer effective), according to Investigator judgement, or the patient declines standard of care therapy
Cancer diagnosis for participants for Part 2A: Metastatic NSCLC diagnosed by histology
and/or cytology not amenable to available standard of care
Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria
For all participants
Positive GPC3 expression on tumor tissue as determined locally or centrally
Capable of giving signed informed consent

Exclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
Predicted life expectancy ≤3 months
For participants with HCC: Child Pugh Class B or C liver score within 14 days of initiation of IMP. Participants with Child Pugh Class B-7 score are allowed for Part 1A
Known active brain metastases or leptomeningeal metastases
History of allogenic or solid organ transplant
Treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity
Significant cardiovascular disease within 3 months prior to initiation of IMP, uncontrolled arrhythmia requiring medication, or unstable angina
Ongoing AEs caused by any prior anti-cancer therapy >Grade 2
Known uncontrolled human immunodeficiency virus (HIV), hepatitis B infection, or known untreated current hepatitis C infection
Known second malignancy either progressing or requiring active treatment within the last year
For combination therapy: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
Receipt of a live-virus vaccination within 28 days of planned treatment start
For Part 2A, has received prior GPC3 targeted anticancer treatment
Current pneumonitis or interstitial lung disease, or history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management
NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended
to contain all considerations relevant to a patient's potential participation in a clinical
trial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

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

Loading...

Browse trials for

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

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note