Experimental combo aims to tackle Treatment-Resistant cancers

NCT ID NCT07713732

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This early-stage trial tests whether an experimental drug called TLN-499, combined with the approved cancer drug venetoclax, is safe and tolerable for people with certain advanced solid tumors that have stopped responding to standard treatments. The study includes adults with small cell lung cancer, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma. Researchers will monitor side effects, measure drug levels in the blood, and look for any signs that the tumors shrink.

What this could mean

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

Active substance
a combination of an experimental drug called TLN-499 and a targeted cancer drug called venetoclax
What this could lead to
If this combination proves safe and shows signs of shrinking tumors, it could lead to a new treatment option for people with hard-to-treat solid cancers like small cell lung cancer and mesothelioma.
What could go wrong
This is a very early, first-in-human phase 1 trial, so the main goal is safety, not effectiveness. The combination may cause serious side effects or fail to control the cancer.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

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: 1. Adults ≥18 years of age 2. Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma 3. Measurable disease per RECIST v1.1 or mRECIST 4. ECOG performance status 0-1 5. Adequate hematologic, hepatic, renal, and coagulation function. 6. Life expectancy ≥12 weeks 7. Signed informed consent Exclusion Criteria: 1. Active brain metastases 2. Major surgery or severe trauma within 4 weeks before first dose 3. Significant uncontrolled medical conditions preventing study participation 4. Use of prohibited concomitant medications 5. Previous conditions that would interfere with study assessments or safety

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • COBL Clinical Trials - Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144, Australia

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

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