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Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

RECRUITINGPhase 1/2Sponsored by One-carbon Therapeutics AB
Actively Recruiting
PhasePhase 1/2
SponsorOne-carbon Therapeutics AB
Started2025-08-22
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions8

CancerColorectal Cancer (CRC)Gastric CancerGastrooesophageal Junction CancerLung CancerNon-small Cell Lung Cancer (NSCLC)Solid TumorSquamous Cell Carcinoma of Head and Neck

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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