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Advanced Solid TumorPhase 1/2NCT05265091

A Study of KL590586 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing KL590586 Capsule in people with Advanced Solid Tumor, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
KL590586 Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
1 siteChina
Study dates
15 Sep 2021to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage I: locally advanced or metastatic solid tumors that are pathologically diagnosed without standard treatment or intolerant to standard treatments
  • Stage II: locally advanced or metastatic NSCLC, MTC or other solid tumors confirmed by pathology
  • There is at least one measurable target lesion that meets RECIST v1.1 or RANO (only for brain tumor lesions)
  • Age > or = 18 years old at the time of signing the informed consent form, regardless of gender
  • 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
  • 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;
  • 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

Who cannot join

  • 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
  • Symptomatic primary central nervous system (CNS) tumors, brain metastases, leptomeningeal carcinogenesis, or untreated spinal cord compression that the researchers believe require local intervention
  • 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)
  • 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
  • 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)
  • 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)
Show all 16Show fewer
  • Those who have received other clinical trial drug treatment within 28 days before receiving the first study drug treatment
  • 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
  • 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
  • Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage)
  • Any serious and/or uncontrolled comorbidities that may prevent the patient from participating in the study
  • Those who are known to be allergic to any component in the study drug prescription
  • Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption
  • 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
  • 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
  • Other situations where the researcher thinks it is inappropriate to participate in this research

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sichuan Kelun Botai Biopharmaceutical Co.

    Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes

An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of KL590586 Capsules In Patients With Advanced Solid Tumors Carrying RET Fusion Or Mutant Genes

Read the detailed description

This is an open, multicentre phase I/II study. To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties and efficacy of KL590586 in patients with advanced NSCLC, MTC and other solid tumours carrying a RET fusion or mutation gene. Phase I of this study includes a dose-escalation phase and a dose-expansion phase (as needed), which will focus on exploring MTD and/or RP2D of KL590586 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of KL590586 in different cohorts (NSCLC, MTC and other tumour types carrying RET fusions or mutations) of solid tumour patients at the RP2D dose.

Being tested
KL590586 Capsule
Keywords
Lung, NSCLC, Thyroid
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KL590586 CapsuleDrug

    Product Name: KL590586 Capsules Formulation：Capsule Specification: 10mg; 50mg Ingredients: KL590586, microcrystalline cellulose, mannitol, cross-linked sodium carboxymethylcellulose, colloidal silicon dioxide, magnesium stearate, hydroxypropylmethylcellulose hollow capsule

Study groups in NCT05265091
Study groupRoleWhat they receive
KL590586ExperimentalMultiple doses of KL590586 capsule
Receives: Drug: KL590586 Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Dose limiting toxicities (DLT)

    Incidence rate of dose limiting toxicities (DLT)

    Measured: From date of initial dose until up to 28 days for treatment

  2. Phase II: ORR

    Objective response rate (ORR)

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start15 Sep 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
414 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265091
Sponsor's protocol ID
KL400-Ⅰ/Ⅱ-01
Status last verified
May 2026
First submitted
14 Feb 2022
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KL590586 Capsule in people with Advanced Solid Tumor, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Dose limiting toxicities (DLT) (time frame: From date of initial dose until up to 28 days for treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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