RecruitingPhase 1Phase 2NCT07151040

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

Sponsor

One-carbon Therapeutics AB

Enrollment

43 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck Solid Tumor Colorectal Cancer (CRC)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called TH9619 in people with advanced cancers that have spread or cannot be surgically removed. Researchers want to understand how safe the drug is and whether it shows signs of working. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer, or stomach/gastroesophageal cancer that has spread or cannot be removed by surgery - You have already received at least one round of chemotherapy for your cancer - You are willing to follow all study procedures **You may NOT be eligible if...** - You have other significant medical conditions that the study doctor believes would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTH9619

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.