Experimental combo aims to tackle Treatment-Resistant cancers
NCT ID NCT07713732
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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COBL Clinical Trials - Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
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Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
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Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can armored CAR t cells take down Hard-to-Treat neuroendocrine cancers?
- Engineered immune cells take aim at stubborn lung cancer
- Could a hidden nerve condition be more common in lung cancer than we think?
- Can a gentler drug trio tame small cell lung cancer in older patients?
- New drug cocktail aims to shrink Hard-to-Treat gut tumors