TH9619 for advanced solid tumors (Phase 1/2)

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

This trial will try different doses of TH9619 in adults with advanced solid tumors (including colorectal, head and neck, non-small cell lung, and gastroesophageal cancers) to find a recommended dose and check safety.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: OneCarbon (industry)
• Locations: 4 sites (Villejuif and 3 other locations)
• Trial ID: NCT07151040 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, multicenter, open-label dose-escalation Phase 1/2 study of TH9619 in adults with histologically confirmed advanced solid tumors. The trial enrolls patients who have received at least one prior line of cytotoxic systemic therapy and will escalate doses to define a recommended dose range. Key evaluations will include safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. The study is being conducted at specialist oncology centers in Europe and will use standard early-phase cohort rules to guide dose escalation.

Who should consider this trial

Good fit: Adults (≥18) with histopathologically confirmed advanced or metastatic colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, or gastric/gastroesophageal junction cancer who have received at least one prior line of cytotoxic systemic therapy and can comply with study procedures are ideal candidates.

Not a fit: Patients with significant uncontrolled comorbidities or other clinically significant disorders as judged by the investigator, or those with earlier-stage disease who have not received prior systemic therapy, are unlikely to benefit from this dose-escalation trial.

Why it matters

Potential benefit: If successful, TH9619 could provide a new treatment option for patients with advanced, treatment-resistant solid tumors by offering clinical activity with an acceptable safety profile.

How similar studies have performed: This is a first-in-human agent; while other early-phase targeted or novel therapies in advanced solid tumors have sometimes shown promising signals, the approach for TH9619 is exploratory and not yet established.

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.

Where this trial is running

Villejuif and 3 other locations

• Institut Gustave Roussy — Villejuif, France (RECRUITING)
• Vall D Hebron Institute Of Oncology — Barcelona, Spain (RECRUITING)
• Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (RECRUITING)
• Newcastle University — Newcastle upon Tyne, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Victoria Moody

Conditions: Solid Tumor, Colorectal Cancer, Squamous Cell Carcinoma of Head and Neck, Non-Small Cell Lung Cancer, Gastrooesophageal Junction Cancer, Gastric Cancer