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 |
Trial Parameters
Eligibility Fast-Check
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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.