Status:
RECRUITING
Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
Lead Sponsor:
One-carbon Therapeutics AB
Conditions:
Solid Tumor
Colorectal Cancer (CRC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
Inclusion
- 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
Exclusion
- • History or presence of any clinically significant disorders as judged by the Investigator.
Key Trial Info
Start Date :
August 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT07151040
Start Date
August 22 2025
End Date
December 1 2026
Last Update
November 26 2025
Active Locations (4)
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1
Institut Gustave Roussy
Villejuif, France
2
Vall D Hebron Institute Of Oncology
Barcelona, Spain
3
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
4
Newcastle University
Newcastle upon Tyne, United Kingdom