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New pill targets rare gene mutations in advanced cancers

NCT ID NCT05265091

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study tests an experimental drug called KL590586, taken as a capsule, in people with advanced solid tumors that have specific RET gene changes. The trial has two phases: Phase I checks safety and the right dose, while Phase II looks at how well the drug shrinks tumors. Up to 414 participants with cancers like lung or thyroid that have not responded to standard treatments will be enrolled.

What this could mean

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

Active substance
KL590586 capsules
What this could lead to
If successful, this could provide a new targeted treatment option for people with advanced solid tumors that have specific RET gene changes.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects and limited benefit are possible.

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 414 people

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

Started

Sep 2021

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: 1. Stage I: locally advanced or metastatic solid tumors that are pathologically diagnosed without standard treatment or intolerant to standard treatments 2. Stage II: locally advanced or metastatic NSCLC, MTC or other solid tumors confirmed by pathology 3. There is at least one measurable target lesion that meets RECIST v1.1 or RANO (only for brain tumor lesions) 4. Age \> or = 18 years old at the time of signing the informed consent form, regardless of gender 5. Within 14 days before the first administration of the study treatment, the Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, and there was no sudden deterioration, and the expected survival time was \> or = 3 months 6. Sufficient organ and bone marrow function (without receiving blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor therapy, renal replacement therapy, etc. within 7 days before the examination, the laboratory examination meets the following conditions Regulations): a) Blood routine: absolute neutrophil count (ANC) \> or = 1.0×10\^9/L; platelet count (PLT) \> or = 75×10\^9/L; hemoglobin concentration \> or = 9.0 g/dl; b) Liver function: AST and ALT \< or = 2.5×upper limit of normal (ULN), TBIL\< or = 1.5×ULN; for patients with liver metastasis or primary biliary tract tumors, ALT and AST \< or = 5×ULN; for liver cancer, liver metastasis or Gil Patients with Gilbert's syndrome, TBIL \< or = 3×ULN; c) Renal function: serum creatinine (Cr) \< or = 1.5×ULN or creatinine clearance \> or = 40 ml/min (using the standard Cockcroft-Gault formula); d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT) and prothrombin time (PT) \< or = 1.5×ULN; 7. Able to understand and voluntarily sign an informed consent form, and be able to comply with the visit and related procedures stipulated in the plan Exclusion Criteria: 1. There are known major driver gene changes other than RET. For example, NSCLC carrying targeted mutations such as EGFR, ALK, ROS1 or BRAF; colorectal cancer carrying mutations such as oncogenic KRAS, NRAS or BRAF. If the patient has a co-mutation, the investigator should discuss with the sponsor whether the patient can be included in the group 2. Symptomatic primary central nervous system (CNS) tumors, brain metastases, leptomeningeal carcinogenesis, or untreated spinal cord compression that the researchers believe require local intervention 3. People with other active malignant tumors (except for non-melanoma skin cancer in situ, cervical cancer in situ and other localized tumors that have been cured and have not recurred within 5 years) 4. Need to use drugs known to be potent inhibitors or inducers of CYP3A4, drugs known to prolong QTc, and the treatment cannot be terminated at least 14 days before the study drug is administered 5. Received the following anti-tumor treatments: a) The previous anti-tumor drug treatment (except immunotherapy or other antibody therapy) is less than 14 days or 5 half-lives (whichever is longer) from the first treatment with study drug; b) In Those who have received any immunotherapy or other antibody treatment within 28 days before the first study drug administration; c) Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 28 days before the first study drug treatment (the patients receiving palliative radiotherapy are the first Within 7 days before receiving study drug treatment) 6. Received major surgical operations within 28 days before receiving the first study drug treatment (excluding operations such as central venous catheter placement, tumor biopsy, and gastric tube placement) 7. Those who have received other clinical trial drug treatment within 28 days before receiving the first study drug treatment 8. Any original symptoms that may interfere with the results of the study, including: any unrecovered toxicity above grade 1 of the CTCAE related to previous anti-tumor therapy (hair loss and grade 2 neuropathy related to previous platinum-based drug treatment, etc.) Except for chronic toxicity judged by the person 9. Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment, or those who have been found or suspected of having such diseases during the screening period 10. Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage) 11. Any serious and/or uncontrolled comorbidities that may prevent the patient from participating in the study 12. Those who are known to be allergic to any component in the study drug prescription 13. Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption 14. Active hepatitis B (hepatitis B surface antigen is positive and HBV-DNA is higher than the upper limit of normal detection) or hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the upper limit of normal detection); Human immunodeficiency virus (HIV) examination Positive or known acquired immunodeficiency syndrome (AIDS); Treponema pallidum antibody test is positive 15. Pregnant or breastfeeding women, fertility patients (regardless of male and female) who cannot take effective medical contraceptive measures during the study period and within 6 months after the last administration 16. Other situations where the researcher thinks it is inappropriate to participate in this research

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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.

Contacts and locations

Locations

  • Sichuan Kelun Botai Biopharmaceutical Co.

    Chengdu, Sichuan, 610000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.