Actively Recruiting
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Led by Sanofi · Updated on 2026-01-20
542
Participants Needed
22
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors. The study will include 2 parts: A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable. A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable. Approximately 542 participants will be exposed to the study intervention: * approximately 123 participants in part 1, * up to 410 participants in expansion/dose optimization part (part 2) * and up to 9 participants in Japan cohort F.
CONDITIONS
Official Title
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Participants in dose escalation Part 1A and Japan Cohort F must have advanced unresectable or metastatic solid tumors with no suitable standard therapy.
- Participants in dose escalation Part 1B must have advanced unresectable or metastatic melanoma, NSCLC, RCC, HCC, colorectal cancer (MSI-H/dMMR), malignant pleural mesothelioma, or ESCC with no suitable standard therapy.
- Participants in dose escalation Part 1C must have confirmed advanced unresectable or metastatic colorectal cancer including RAS-mutant and BRAF-mutant types.
- Participants in dose expansion/optimization Part 2 must have specific confirmed advanced cancers such as NSCLC, HCC, gastric cancer, gastroesophageal junction adenocarcinoma, colorectal cancer, or melanoma as detailed.
- Participants in Part 2 must have received prior anticancer therapy as specified for each cohort.
- Participants must have at least one measurable lesion per RECIST 1.1 criteria.
- Participants in Part 1C and Part 2D must have adequate coagulation function.
- Participants must be capable of giving signed informed consent.
You will not qualify if you...
- ECOG performance status of 2 or higher.
- Predicted life expectancy of 3 months or less.
- For HCC Cohort B (Part 2), Child Pugh Class B or C liver score (except Class B-7 allowed in Part 1).
- Diagnosis of other malignancies progressing or needing active treatment within 2 years before enrollment.
- Known active brain or leptomeningeal metastases.
- History of severe immune-related adverse events causing treatment discontinuation or unresolved severe immune reactions.
- Need for ongoing corticosteroid therapy over 10 mg prednisone/day within 1 week before first study drug dose.
- Significant heart or vascular disease within 6 months before first study drug dose.
- Recent or ongoing serious autoimmune disease requiring immunosuppressive treatment within 2 years.
- History or evidence of interstitial lung disease or active non-infectious pneumonitis within 3 years before first dose.
- Organ transplant requiring immunosuppressive treatment.
- Uncontrolled or active HIV, hepatitis B or C infection, or immunodeficiency diagnosis.
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Christiana Care Health System- Site Number : 8400011
Newark, Delaware, United States, 19713-2072
Actively Recruiting
2
University of Iowa- Site Number : 8400014
Iowa City, Iowa, United States, 52242-1009
Actively Recruiting
3
University of Kansas Cancer Center Clinical Research Center (Fairway) Site Number : 8400008
Fairway, Kansas, United States, 66205-2528
Actively Recruiting
4
Barbara Ann Karmanos Cancer Institute - Detroit- Site Number : 8400006
Detroit, Michigan, United States, 48201
Actively Recruiting
5
John Theurer Cancer Center Site Number : 8400001
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
NYU Langone Medical Center-New York- 550 1st Ave - BRANY - PPDS- Site Number : 8400013
New York, New York, United States, 10016-6402
Actively Recruiting
7
Rhode Island Hospital Site Number : 8400004
Providence, Rhode Island, United States, 02903
Actively Recruiting
8
University of Texas MD Anderson Cancer Center Site Number : 8400005
Houston, Texas, United States, 77030-4000
Actively Recruiting
9
Fred Hutchinson Cancer Center - 825 Eastlake Ave E- Site Number : 8400010
Seattle, Washington, United States, 98109-4405
Actively Recruiting
10
Servicios Médicos URUMED SpA_Investigational Site Number : 1520002
Rancagua, General Bernardo O'Higgins, Chile, 2852424
Actively Recruiting
11
BIOCINETIC Ltda_Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago, Chile, 8350595
Actively Recruiting
12
Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805_Investigational Site Number : 1520007
Providencia, Chile, 7500000
Actively Recruiting
13
Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004
Recoleta, Chile, 8420391
Actively Recruiting
14
Hadassah Medical Center - PPDS_Investigational Site Number : 3760005
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
15
Shamir Medical Center_Investigational Site Number : 3760004
Be’er Ya‘aqov, Israel, 70300
Actively Recruiting
16
Sheba Medical Center - PPDS_Investigational Site Number : 3760003
Ramat Gan, Israel, 5262100
Actively Recruiting
17
Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001
Tel Aviv, Israel, 6423906
Actively Recruiting
18
Investigational Site Number : 3920001
Kashiwa-Shi, Japan, 277-0882
Actively Recruiting
19
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
20
Erasmus MC_Investigational Site Number : 5280003
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
21
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007
Barcelona, Spain, 08035
Actively Recruiting
22
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005
Madrid, Spain, 28050
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
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