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Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
Sponsor: One-carbon Therapeutics AB
Summary
This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.
Official title: A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2025-08-22
Completion Date
2026-12
Last Updated
2026-01-28
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
Institut Gustave Roussy
Villejuif, France
Vall D Hebron Institute Of Oncology
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Newcastle University
Newcastle upon Tyne, United Kingdom