Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

August 22, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Solid TumorColorectal Cancer (CRC)Squamous Cell Carcinoma of Head and NeckNon-Small Cell Lung Cancer (NSCLC)Gastrooesophageal Junction CancerGastric Cancer
Interventions
DRUG

TH9619

"Phase 1a - DOSE ESCALATION~Description:~Single arm dose escalation of TH9619 as monotherapy.~Phase 1b - DOSE EXPANSION~Description:~Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available."

Trial Locations (4)

Unknown

NOT_YET_RECRUITING

Institut Gustave Roussy, Villejuif

NOT_YET_RECRUITING

Vall D Hebron Institute Of Oncology, Barcelona

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

NOT_YET_RECRUITING

Newcastle University, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

One-carbon Therapeutics AB

INDUSTRY