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GEN1119

Phase 1

Solid Tumours | Small molecule | Oncology |Genmab A/S|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

GEN1119 · 1 trial · 1 indication

Phase 1 1
NCT07695831A Phase 1 Trial of GEN1119 in Participants With Solid TumorsSolid Tumours
RECRUITING112 Analytics
PHASE1RECRUITING
A Phase 1 Trial of GEN1119 in Participants With Solid Tumors
Solid TumoursUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Number of Participants with Dose-limiting Toxicities (DLTs)
21 days
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
Up to approximately 17.5 months
Part 3: Objective Response Rate (ORR)
Up to approximately 17.5 months

Secondary Endpoints

Part 1, Part 2 and Part 3: Plasma Concentration of GEN1119-related Analytes
Up to approximately 17.5 months
Part 1, Part 2 and Part 3: Number of Participants with Anti-drug Antibodies (ADAs) Against GEN1119
Up to approximately 17.5 months
Part 1 and Part 2: ORR
Up to approximately 17.5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation (Part 1): GEN1119EXPERIMENTALParticipants will receive a number of dose levels (DLs) of GEN1119.
Dose Refinement (Part 2): GEN1119EXPERIMENTALParticipants will be randomized to receive a number of DLs of GEN1119.
Expansion (Part 3): GEN1119EXPERIMENTALParticipants with certain solid tumours will receive GEN1119 at the recommended expansion dose(s) as defined in Parts 1 and/or 2.

Interventions

NameTypeDescription
GEN1119DRUGAdministered at certain DLs on specified days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Have histologically or cytologically confirmed diagnosis of protocol-specified solid tumours. * Have progressed on standard of care (SoC) therapy applicable for the tumor type, or for whom there is no available SoC therapy likely to provide clinical benefit, and for whom e...

Countries:FranceJapan
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumours")

Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07695831Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 3, 2026NCT07695831Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 4, 2026NCT07695831lastUpdatePostDate: changed
LOWAug 4, 2026NCT07695831lastUpdatePostDate: changed
LOWJul 10, 2026NCT07695831NEW_TRIAL: changed
LOWJul 10, 2026NCT07695831NEW_TRIAL: changed

Frequently asked questions about GEN1119

What is GEN1119 used for?

GEN1119 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, and no efficacy or safety data have been reported yet. The drug is not approved by regulatory authorities and remains under investigation.

Who is developing GEN1119?

GEN1119 is being developed by Genmab A/S, a biopharmaceutical company listed on the Nasdaq under the ticker GMAB. The company is conducting a Phase 1 clinical trial to evaluate the drug in participants with solid tumors.

What phase is GEN1119 in?

GEN1119 is in Phase 1 clinical development. A Phase 1 trial is currently recruiting participants with solid tumors. The drug is investigational and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is GEN1119 in?

GEN1119 is being studied in a Phase 1 clinical trial with the identifier NCT07695831, titled "A Phase 1 Trial of GEN1119 in Participants With Solid Tumors." The trial is actively recruiting and aims to enroll 112 participants in France and Japan.

Is GEN1119 being tested in a randomized controlled trial?

Yes, the Phase 1 clinical trial of GEN1119 (NCT07695831) is randomized and controlled, but it is not double-blinded. The study is enrolling participants with solid tumors and is currently recruiting in France and Japan.