New pill targets RET-Driven cancers in early trial
NCT ID NCT05451602
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new oral drug called HEC169096 in people with advanced solid tumors, including thyroid cancer and non-small cell lung cancer, that have a specific RET gene change. The trial has two phases: the first finds the safest dose, and the second checks how well the drug shrinks tumors. About 456 participants will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HEC169096 (a RET inhibitor drug taken by mouth)
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced solid tumors that have a specific RET gene change.
- What could go wrong
- This is an early-phase trial, so the drug may not work or could have side effects. It is only for people with certain RET gene changes, so it won't help everyone.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 456 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Aug 2027
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: * Phase 1:Pathologically documented, definitively diagnosed non-resectable advanced solid tumor. * Phase 2: All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor. * Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. * Measurable or non-measurable disease as determined by RECIST 1.1; * Adequate hematologic, hepatic and renal function; * Life expectancy of at least 12 weeks; * Negative pregnancy test (urine or serum) for female patients of childbearing potential; * Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy). Exclusion Criteria: * Participant's cancer has a known primary driver alteration other than RET. * Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment; * Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment; * Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment); * Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment; * Had received live vaccine within 4 weeks prior to study treatment; * Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials; * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment . * Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms. * Patients with other malignant tumors within 5 years before the first use of drugs * Patients have a history of severe cardiovascular disease; * Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL or ≥ 10\^4 cps/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive. * Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment; * Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage); * Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption; * Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.
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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
1 site. 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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GuangDong Province Peoples Hospital
RECRUITINGGuangzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink advanced solid tumors?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug shrink tumors that resist standard care?
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a Three-Dose immunotherapy cure early lung cancer without surgery?