TH9619 for advanced solid tumors (Phase 1/2)
Official title: 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
Run by OneCarbon · NCT07151040 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 43 (estimated) |
| Sponsor | OneCarbon Industry-sponsored |
| Locations | 4 sites (Villejuif and 3 other locations) |
| Status | Recruiting |
| Started | August 22, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07151040 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: victoria.moody@one-carbon.com
- Phone: +46708555182
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Dose-finding of EXS74539 (REC-4539) in select solid tumors
This study will try different doses of the experimental drug EXS74539 in adults with select solid tumors to find a safe and tolerable dose.
-
JYP0015 for adults with advanced RAS‑mutant solid tumors
This trial tests whether the oral drug JYP0015 is safe and can shrink tumors in adults whose advanced solid cancers have specific RAS mutations.
-
Zanzalintinib with immune checkpoint drugs for advanced solid tumors
This trial will test whether zanzalintinib alone or combined with immune drugs (nivolumab, with or without ipilimumab or relatlimab) is safe and helps people with advanced or metastatic solid tumors such as renal cell, prostate, urothelial, and liver cancers.
-
First-in-human imaging study of 68Ga-DFC413 and comparison with 68Ga-NNS309 in solid tumors
This study tests a new radioactive imaging agent, 68Ga-DFC413, to see how it behaves in patients with several solid tumors and compares it to 68Ga-NNS309.
-
BPI-572270 in RAS-mutant advanced solid tumors (including NSCLC, CRC, PDAC)
This study tests whether BPI-572270 is safe and tolerable in adults with RAS-mutant advanced solid tumors and looks for signs of clinical activity.
-
Givastomig with nivolumab and chemotherapy for CLDN18.2-positive metastatic stomach or gastroesophageal junction cancer
This study will see if adding givastomig to nivolumab plus standard chemotherapy helps adults with CLDN18.2- and PD-L1-positive metastatic stomach or gastroesophageal junction cancer live longer without their disease getting worse.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.