Recent Updates
Recently added Catalysts

REGN7075

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 2, 2026

Target and mechanism

Molecular targetEGFR, CD28
Target classProtein
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment548

FDA Designations

No designations recorded

Clinical trial landscape

REGN7075 · 1 trial · 1 indication

Phase 1 1
NCT04626635A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced CancersAdvanced Solid Tumors
ACTIVE NOT_RECRUITING548 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period
Up to 6 weeks

Dose escalation

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Approximately 90 days from last dose; up to 5 years

Dose escalation

Incidence and severity of Adverse Events of Special Interest (AESIs)
Approximately 90 days from last dose; up to 5 years

Dose escalation

Incidence and severity of Serious Adverse Events (SAEs)
Approximately 90 days from last dose; up to 5 years

Dose escalation

Incidence and severity of grade ≥3 laboratory abnormalities
Approximately 90 days from last dose; up to 5 years

Dose escalation

Objective Response Rate (ORR)
Up to 5 years

Dose expansion

Secondary Endpoints

Concentrations of marlotamig in serum
Up to 5 years
ORR
Up to 5 years
Progression Free Survival (PFS)
Up to 5 years
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALVariety of mixed advanced solid tumor types
Dose Expansion AEXPERIMENTALTriple Negative Breast Cancer (TNBC)
Dose Expansion BEXPERIMENTALCutaneous Squamous Cell Carcinoma (CSCC)
Dose Expansion CEXPERIMENTALNon-Small Cell Lung Cancer (NSCLC)
Dose Expansion DEXPERIMENTALHead and Neck Squamous Cell Carcinoma (HNSCC)
Dose Expansion EEXPERIMENTALMicrosatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases
Dose Expansion FEXPERIMENTALMSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases)
Dose Expansion GEXPERIMENTALEpidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI)
Dose Expansion HEXPERIMENTALEGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy
Dose Expansion IEXPERIMENTALThird-line (3L) MSS-CRC with Active Liver Metastases
Dose Expansion JEXPERIMENTAL3L MSS-CRC without Active Liver Metastases

Interventions

NameTypeDescription
REGN7075DRUGIntravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
CemiplimabDRUGAdministered concomitantly Q3W by IV infusion or SC injection
Platinum-based doublet chemotherapyDRUGAdministered IV Q3W
BevacizumabDRUGAdministered per protocol
Trifluridine-tipiracilDRUGAdministered per protocol
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

Key Inclusion Criteria: 1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 2. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol 3. Expansion Cohorts only: Is anti-Programmed cell Death protein-1 (PD-1)/Programmed cell D...

Countries:United StatesFranceIsraelNetherlandsPolandSpainTurkey (Türkiye)
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Recent Changes (Last 90 Days)

HIGHJul 2, 2026NCT04626635Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 2, 2026NCT04626635Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 2, 2026NCT04626635Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about REGN7075

What is REGN7075 used for?

REGN7075 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, where it is being studied in combination with cemiplimab for adult participants with advanced cancers.

What does REGN7075 target?

REGN7075 targets EGFR and CD28. EGFR is a receptor tyrosine kinase often involved in cell growth, while CD28 is a costimulatory receptor on T cells. By targeting these proteins, REGN7075 is designed to modulate immune responses against tumors.

Who makes REGN7075?

REGN7075 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is REGN7075 in?

REGN7075 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness in patients with advanced solid tumors.

What clinical trials is REGN7075 in?

REGN7075 is being studied in a Phase 1 clinical trial with the identifier NCT04626635. This trial is titled 'A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers' and is currently active but not recruiting participants.

Is REGN7075 the same as cemiplimab?

No, REGN7075 is not the same as cemiplimab. REGN7075 is a small molecule targeting EGFR and CD28, while cemiplimab is a separate drug that targets PD-1. In the clinical trial, REGN7075 is being studied in combination with cemiplimab for the treatment of advanced solid tumors.