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

ConditionsSolid Tumor Colorectal Cancer (CRC)Squamous Cell Carcinoma of Head and Neck Non-Small Cell Lung Cancer (NSCLC)Gastrooesophageal Junction Cancer Gastric Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorOne-carbon Therapeutics AB

About this trial

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

Qualifiers

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)

Disqualifiers

None

Trial design

Treatments tested in this trial

TH9619

Treatment groups

43 Participants

are divided into 1 treatment group

Locations

France

Institut Gustave Roussy Villejuif France

Spain

Vall D Hebron Institute Of Oncology Barcelona Spain

Hospital Universitario Fundacion Jimenez Diaz Madrid Spain

United Kingdom

Newcastle University Newcastle upon Tyne United Kingdom

Sponsors and collaborators

One-carbon Therapeutics AB

Lead sponsor

Source ClinicalTrials.gov