NCT07151040 Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
| NCT ID | NCT07151040 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | One-carbon Therapeutics AB |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 43 participants in total. It began in 2025-08-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria: * 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 Criteria: • History or presence of any clinically significant disorders as judged by the Investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07151040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07151040 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07151040 currently recruiting?
Yes, NCT07151040 is actively recruiting participants. Contact the research team at victoria.moody@one-carbon.com for enrollment information.
Where is the NCT07151040 trial being conducted?
This trial is being conducted at Villejuif, France, Barcelona, Spain, Madrid, Spain, Newcastle upon Tyne, United Kingdom.
Who is sponsoring the NCT07151040 clinical trial?
NCT07151040 is sponsored by One-carbon Therapeutics AB. The trial plans to enroll 43 participants.