Trials / Recruiting
RecruitingNCT07151040
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- Sponsor
- One-carbon Therapeutics AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Tumor
- Colorectal Cancer (CRC)
- Squamous Cell Carcinoma of Head and Neck
- Non-Small Cell Lung Cancer (NSCLC)
- Gastrooesophageal Junction Cancer
- Gastric Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TH9619 | Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy. Phase 1b - DOSE EXPANSION Description: Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available. |
Timeline
- Start date
- 2025-08-22
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2025-09-02
- Last updated
- 2026-01-28
Locations
4 sites across 3 countries: France, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT07151040. Inclusion in this directory is not an endorsement.