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New hope for advanced cancers? first human trial of TH9619 begins

NCT ID NCT07151040

Disease control Sponsor: One-carbon Therapeutics AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental drug called TH9619 in about 43 adults with advanced solid tumors, including colorectal, head and neck, lung, and gastric cancers. The main goal is to check the drug's safety and find the right dose. Participants must have already tried at least one standard chemotherapy. The study is open-label, meaning everyone knows they are getting the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TH9619 (an experimental drug)
What this could lead to
If this trial succeeds, it could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early, first-in-human study with only 43 participants. The drug may not be safe or effective, and side effects are unknown. Many early-stage cancer drugs fail to advance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 43 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma non-small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (CRC) Gastric cancer Gastrooesophageal junction cancer Non-small cell lung cancer (NSCLC) Solid tumor Squamous cell carcinoma of head and neck

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Newcastle University

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Vall D Hebron Institute Of Oncology

    RECRUITING

    Barcelona, Spain

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