Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors

NCT06651593 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0829NCI-2024-08852
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To study possible biomarkers that may be related to how SAR444881 works (either alone or when combined with cemiplimab) in participants with solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with SAR444881 and Cemiplimab

EXPERIMENTAL

SAR444881 will be given by vein over about 60 minutes on Day 1 of each cycle. Cemiplimab will be administered by vein over about 30 minutes on Day 1 of each cycle, starting with Cycle 2. During Cycle 1, you will only receive SAR444881. Starting on Day 1 of Cycle 2 and for all other cycles, you will receive both SAR444881 and cemiplimab.

Drug: SAR444881; Drug: Cemiplimab

Interventions

SAR444881 DRUG

Given by IV

Treatment with SAR444881 and Cemiplimab

Cemiplimab DRUG

Given by Iv

Treatment with SAR444881 and Cemiplimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign an informed consent form (ICF) prior to initiation of the study and any study procedures.
• Age 18 years.
• Participants with histologically documented locally advanced or metastatic solid tumor:
• Cohort 1: NSCLC
• Cohort 2: MSS CRC and ovarian cancer
• Prior 10 therapy exposure (Cohort 1 only).
• Anti-PD-1/PD-L1 na"i"ve (Cohort 2 only).
• One lesion suitable for repeat biopsy without significant risk to the patient.
• Measurable disease per the Response Evaluation Criteria in Solid Tumors. Measurable disease should not be the lesion needed for repeat biopsy.
• Eastern Cooperative Oncology Group (ECOG) performance status of O or 1.
• Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
• Hemoglobin \>9.0 g/dl (red blood cell/plasma transfusion is not allowed within 2 weeks prior to screening assessment erythropoiesis-stimulating agents/colony- stimulating factors are not allowed within 1 week prior to screening assessment)
• Absolute neutrophil count 1500/ml (growth factors are not allowed within 2 weeks prior to screening assessment)
• Platelets 75,000/ml
• Total bilirubin $1.5 x institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is $3 x ULN.

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
• Participants who are pregnant or breastfeeding.
• Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment initiation. Inhaled or topical steroids, and adrenal replacement steroid doses 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
• Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
• Participants with acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be excluded. Participants with chronic HBV or HCV with undetectable viral load will be eligible.
• Previous solid organ or allogeneic HSCT.
• Known brain or leptomeningeal metastases.
• Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.
• Unresolved toxicities from prior therapy (defined as having not resolved to :51 Grade or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and :5 Grade 2 peripheral neuropathy.
• Participants who have previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required permanent discontinuation or systemic immunosuppression due to irAEs (Cohort 1 only).
• Participants who are receiving any other investigational agents.
• Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of study treatment.
• Participants must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 2 weeks or 5 half-lives (whichever is shorter) from any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); and 4 weeks from radiation therapy. Palliative radiotherapy is permitted for a preexisting lesion, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be a site of measurable disease).
• Prior treatment with ILT2 or ILT4 inhibitor.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: collaborator
• M.D. Anderson Cancer Center: lead
• Sanofi: collaborator

Study Sites (1)

Md Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

cemiplimab

Study Officials

• Aung Naing, Md

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aung Naing, Md

CONTACT

713-563-3885; anaing@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: July 2, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)