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A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

NCT04626635 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 933

Last updated 2026-04-09

No results posted yet for this study

Summary

This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage.

The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.

The study is also looking at:

* Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy
* How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy
* How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
* To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor
* Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)

Conditions

Interventions

DRUG

REGN7075

Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)

DRUG

Cemiplimab

Administered concomitantly Q3W by IV infusion or SC injection

DRUG

Platinum-based doublet chemotherapy

Administered IV Q3W

DRUG

Bevacizumab

Administered per protocol

DRUG

Trifluridine-tipiracil

Administered per protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2026-08-19
Completion
2027-04-07
FDA Drug
Yes

Countries

  • United States
  • France
  • Israel
  • Netherlands
  • Poland
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626635 on ClinicalTrials.gov