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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor, Colorectal Cancer (CRC), Squamous Cell Carcinoma of Head and Neck, Non-Small Cell Lung Cancer (NSCLC), Gastrooesophageal Junction Cancer, Gastric Cancer

In brief

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.

Key facts

Study ID

NCT07151040

Run by

One-carbon Therapeutics AB

People needed

43

Starts

2025-08-22

Expected to finish

2026-12-01

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History or presence of any clinically significant disorders as judged by the Investigator.

Where it is running

• Institut Gustave Roussy — Villejuif, France (enrolling)
• Vall D Hebron Institute Of Oncology — Barcelona, Spain (enrolling)
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
• Newcastle University — Newcastle upon Tyne, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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