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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Must have given written informed consent
• Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer and gastric cancer (including gastroesophageal junction cancer))
• Prior treatment with at least one line of cytotoxic systemic therapy for metastatic/unresectable cancer
• Adult patients (≥18 years of age)
• Must be willing to comply with study procedures
Locations
Other Locations
France
Institut Gustave Roussy
RECRUITING
Villejuif
Spain
Vall D Hebron Institute Of Oncology
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
United Kingdom
Newcastle University
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Victoria Moody
victoria.moody@one-carbon.com
+46708555182
Time Frame
Start Date: 2025-08-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 43
Treatments
Experimental: Single arm dose
Phase 1a (escalation) Single arm dose escalation of TH9619 as monotherapy. Phase 1b (expansion) Single arm dose expansion of TH9619 as monotherapy in selected tumor types.
Related Therapeutic Areas
Sponsors
Leads: One-carbon Therapeutics AB