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A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy for participants aged at least 18 years with advanced unresectable or metastatic malignancies.
The study will include 2 parts:
A dose escalation Part 1: for finding the recommended dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW).
A multicohort dose expansion Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy (2 dose levels will be tested in at least 1 indication as applicable).
Approximately 240 participants will be enrolled to the study intervention:
For Part 1: approximately 75 participants, For Part 2: up to 30 participants will be enrolled in each cohort per dose level for a total of approximately 165.

Detailed Description

The duration of the study for a participant will include:
Screening Period: up to 28 days Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.
The End of Treatment (EOT) visit will occur 30 days ±7 days from the last IMP administration or prior to the initiation of further therapy, whichever occurs first.
The follow-up period will occur until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.

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Call 1800-9860-568 now to find out if you are eligible.

Age icon
Age
18 - None
Gender icon
Gender
All
NCT ID icon
NCT ID
NCT05584670
Phase icon
Phase
5
Status icon
Status
Recruiting Now
Medical Condition icon
Medical Condition
Solid Tumor

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Medical Condition
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The Study
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About Clinical Trials
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Your Journey

01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.