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

Inclusion Criteria5

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 Criteria1

• History or presence of any clinically significant disorders as judged by the Investigator.

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.