A Study of AK-1286 in Patients With Advanced Solid Tumors

A Phase 1 study testing AK-1286 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of AK-1286 in patients with advanced solid tumors, so as to confirm the recommended phase 2 dose of AK-1286 and obtain the preliminary efficacy information of patients with advanced solid tumors. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Solid Tumor
What is being tested?: AK-1286
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 1 Feb 2025to 1 Oct 2026
Phase: Phase 1
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-75 years (including cut-off value), gender is not limited;
Patients with histologically or cytologically diagnosed advanced malignant solid tumors who have failed or are unable to tolerate standard treatment regimens with systemic standard therapy.
participants in the dose expansion phase must have quantifiable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Anticipated minimum survival duration of 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants must meet the laboratory criteria.A. Bone marrow function needs to meet#ANC≥1.5×109/L#PLT≥100×109/L#Hb≥9g/dL B. renal function#Cr≤1.5 times the upper limit of normal value#or Creatinine clearance≥50ml/min C. liver function#total bilirubin<1.5 x ULN#For subjects with documented Gilbert syndrome,< 2.0 x ULN or subjects with indirect bilirubin levels suggesting a source of extrahepatic elevation<3.0 x ULN#ALT and AST≤ 2.5 x ULN#If liver metastasis occurs≤ 5 x ULN#D. Coagulation function#Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper normal limit (ULN), or international normalized ratio (INR) < 1.5 or within the target range (if preventive anticoagulant therapy is performed# E). The corrected QT interval (QTcF) of Fridericia method is less than 450 ms for males and less than 470 ms for females.

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The elution period of macromolecular drugs is ≥ 4 weeks, and that of oral fluorouracil and small molecule targeted drugs is ≥ 2 weeks
Fertile women must have a negative blood pregnancy test within 7 days before receiving the first study drug;
For fertile men and women, they must be willing to use appropriate contraceptive methods 30 days before the first study drug administration and 120 days after the last study drug administration;
Did not participate in the clinical trial as a subject within 1 month before participating in the trial;
According to the judgment of the researcher, the compliance is high,willing to complete the test and can abide by the test scheme;
Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent form in writing.

Who cannot join

Untreated patients with brain metastasis
Other malignant tumors in recent five years. Basal cell carcinoma of the skin, except squamous cell carcinoma of the skin or cervical carcinoma in situ after potential treatment;
Myocardial infarction, symptomatic congestive heart failure (New York Heart Association > grade II), unstable angina pectoris or arrhythmia requiring drug treatment occurred within 6 months before enrollment;
Have a history of gastrointestinal diseases or gastric surgery or inability to swallow oral drugs;
Active infection requiring treatment;
Patients with active hepatitis B (hepatitis B surface antigen and / or hepatitis B core antibody positive and HBV-DNA > 103 copies /mL or 200IU/mL) or hepatitis C patients (hepatitis C virus positive and / or HCV-RNA positive) or HIV positive patients are required to receive treatment.

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Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first use of the study drug, or elective surgery during the trial, or therapeutic or palliative radiotherapy within 2 weeks before the first use of the study drug;
Allergic constitution, or known history of allergy to this drug component;
According to the researchers' judgement, there are serious diseases that may endanger the safety of patients or affect the completion of research, such as uncontrollable hypertension, uncontrollable diabetes and thyroid diseases.
There is fluid accumulation in the third space that cannot be controlled by drainage or other methods (such as massive identification and hydrothorax)
Have a clear history of neurological or mental disorders；
The researchers believe that the subjects are not suitable to participate in this study for other reasons.

About this study

Official title: A Phase 1,Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of AK-1286 in Patients With Advanced Solid Tumors

Conditions: Advanced Solid Tumor
Being tested: AK-1286

What participants receive

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

AK-1286Drug
Cohort 1: 1 mg/d QD AK-1286 PO,DLT observation period: 21 days. Cohort 2: 2 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 3: 4 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 4: 5 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 5: 16 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 6: 24 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 7: 36 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 8: 50 mg/d BID AK-1286 PO,DLT observation period: 21 days.

Study groups in NCT06779045
Study group	Role	What they receive
AK-1286	Experimental	After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once or twice daily until documented disease progression, unacceptable AEs, intercurrent illness prevents further administrations of study treatment, investigator's decision to withdraw the patient, the patient withdraws consent, pregnancy of the patient, or for administrative reasons. Following the end of treatment, patients will continue to be followed for safety for 30 days. Patients who permanently discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first. Receives: Drug: AK-1286

What is being measured

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

Occurrence of drug limited toxicities (DLTs)
To assess by the occurrence of Drug Limited Toxicities (DLTs)
Measured: From Time of First dose through DLT observation period, 21 days
Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Number of patients with changes in laboratory parameters from baseline
To assess safety of AK-1286
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Number of participants with changes in clinically significant vital sign from baseline
To assess safety of AK-1286
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes (4)

The overall response rate (ORR)
The overall response rate (ORR) will be estimated based on the proportion of evaluable patients whose overall response (ORR) during study treatment is CR or PR. Disease response will be assessed by the investigator using RECIST v1.1.response (ORR) during study treatment is CR or PR. Disease response will be assessed by the investigator using RECIST v1.1
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Progression free survival（PFS）
PFS, defined as the time from the first dose of study treatment to The tumor progresses for the first time
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival（OS）
The time from randomization to death for any reason
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Disease control rate（DCR）
The percentage of cases with remission (PR+CR) and stable lesions (SD) after treatment
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Timeline

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

1 Feb 20251 Oct 2026

First posted16 Jan 2025
Study start1 Feb 2025 (estimated)
Primary completion1 Sep 2026 (estimated)
Study completion1 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06779045
Sponsor's protocol ID: AK-1286-001
Status last verified: Jan 2025
First submitted: 2 Jan 2025
Last updated: 16 Jan 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1,Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of AK-1286 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06779045
Acronym / sponsor ID: AK-1286-001
Conditions: Advanced Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Study start: 1 Feb 2025 (estimated)
Primary completion: 1 Sep 2026 (estimated)
Study completion: 1 Oct 2026 (estimated)
First posted: 16 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AK-1286	Experimental	Drug: AK-1286After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once or twice daily until documented disease progression, unacceptable AEs, intercurrent illness prevents further administrations of study treatment, investigator's decision to withdraw the patient, the patient withdraws consent, pregnancy of the patient, or for administrative reasons. Following the end of treatment, patients will continue to be followed for safety for 30 days. Patients who permanently discontinue study treatment for reasons other than disease progression will have post-treatment follow-up for disease assessment until start of new anticancer treatment, patient withdraws consent, is lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Age 18-75 years (including cut-off value), gender is not limited;
Patients with histologically or cytologically diagnosed advanced malignant solid tumors who have failed or are unable to tolerate standard treatment regimens with systemic standard therapy.
participants in the dose expansion phase must have quantifiable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
Anticipated minimum survival duration of 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key exclusion criteria (12 listed)

Untreated patients with brain metastasis
Other malignant tumors in recent five years. Basal cell carcinoma of the skin, except squamous cell carcinoma of the skin or cervical carcinoma in situ after potential treatment;
Myocardial infarction, symptomatic congestive heart failure (New York Heart Association > grade II), unstable angina pectoris or arrhythmia requiring drug treatment occurred within 6 months before enrollment;
Have a history of gastrointestinal diseases or gastric surgery or inability to swallow oral drugs;
Active infection requiring treatment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK-1286Cohort 1: 1 mg/d QD AK-1286 PO,DLT observation period: 21 days. Cohort 2: 2 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 3: 4 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 4: 5 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 5: 16 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 6: 24 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 7: 36 mg/d BID AK-1286 PO,DLT observation period: 21 days. Cohort 8: 50 mg/d BID AK-1286 PO,DLT observation period: 21 days.	Drug	AK-1286

Primary outcome

Occurrence of drug limited toxicities (DLTs)
Time frame: From Time of First dose through DLT observation period, 21 days
To assess by the occurrence of Drug Limited Toxicities (DLTs)
Incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Number of patients with changes in laboratory parameters from baseline
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
To assess safety of AK-1286
Number of participants with changes in clinically significant vital sign from baseline
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
To assess safety of AK-1286

4 secondary outcomes

The overall response rate (ORR)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Progression free survival（PFS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival（OS）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Disease control rate（DCR）
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK-1286 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd..

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 12 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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?

Occurrence of drug limited toxicities (DLTs) (time frame: From Time of First dose through DLT observation period, 21 days). The study lists 4 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 NCT06779045.

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 16 Jan 2025.