NCT07151040RecruitingPhase 1/2
Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- 22 Aug 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- One-carbon Therapeutics AB
- Diseases
- Head and neck cancer, Lung cancer, Metastatic breast cancer, Colorectal cancer, Gastric and esophageal cancer
- NCT number
- NCT07151040
- EU CT number
- 2024-519639-40-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 43
- From 22 Aug 2025 to the primary completion date, Dec 2026
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History or presence of any clinically significant disorders as judged by the Investigator.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vall d'Hebron Institute of Oncology Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Newcastle University Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.