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Marlotamig

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as REGN7075

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment548

FDA Designations

No designations recorded

Clinical trial landscape

Marlotamig · 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
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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
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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)
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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