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Advanced Solid TumorPhase 1/2NCT05173805

Phase I Clinical Study of YL-15293 in Patients With Advanced Solid Tumor With KRAS Mutation

A Phase 1/2 study testing YL-15293 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase 1 / 2 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-15293 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-15293 and obtain the preliminary efficacy information of patients with advanced… 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?
YL-15293
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
30 Jan 2022to 30 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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

None listed.

Who cannot join

  • Patients with any of the following items cannot be enrolled in this study:
  • Untreated patients with brain metastasis meet one or more of the following conditions：
  • Need to use corticosteroids or dehydration treatment (except those with treated or asymptomatic brain metastases);
  • There are significant clinical symptoms;
  • The tumor stabilization time after radiotherapy or surgery should not exceed 4 weeks.
  • (Except for patients with brain metastasis who have been treated or have no symptoms)
Show all 23Show fewer
  • 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.
  • 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
  • In case of one or more of the following circumstances, the subject shall suspend the test:
  • Subjects asked to withdraw from the study;
  • Imaging evidence shows that the disease is progressing
  • Pregnancy events occurred during the study
  • After dose adjustment, the subject still could not tolerate the toxicity
  • The researcher considers it necessary to withdraw from the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangzhou, 510062

Other trials in China

About this study

Official title: Phase I Clinical Study on the Safety, Tolerance, Pharmacokinetics and Efficacy of YL-15293 in Patients With Advanced Solid Tumor With KRAS Mutation

This is a phase 1 / 2 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-15293 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-15293 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation.

Read the detailed description

Dose escalation stage:

It is planned to include 21-42 subjects into 7 dose groups: 100mg/d, 200mg/d, 400mg/d, 600mg/d, 800mg/d, 1000mg/d and 1200mg/d. Three to six patients were enrolled in each dose group. 100mg/d is used as the initial dose. The dose of single administration phase is 100mg, qd, and the dose of multiple administration phase is 50mg, bid. The daily dose of the 1000mg/d dose group and above in the single administration stage is 1/2 of the daily dose, and the daily dose in the multiple administration stage is divided into two oral doses. The medication frequency (once or twice a day) and PK blood sampling point of the follow-up dose group are adjusted according to the PK parameters of the initial dose group. DLT evaluation is conducted in the first cycle (21 days).

Single-dose PK study: The drug was given once on an empty stomach in the morning on the first day, and the dose was half of the total dose of the day. Before administration (within 30 minutes before administration), pharmacokinetic samples were collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours after administration. A total of 10 blood sampling points were collected, with 4ml blood taken each time .

Multi-dose PK study: 7 days after a single dose, 21 days of continuous administration is a treatment cycle, 2 times a day. On the first day, the 7th day and the 21st day, within 30 minutes before the administration, and 0.5, 1, 2, 3, 4, 6, 8, 10, 24h after the administration on the 21st day, collect the pharmacokinetics Samples, a total of 12 blood collection points, 4ml blood each time.

In addition, in the presence of DLT and SAE, a blood sample must be collected immediately for pharmacokinetic analysis.

Clinical expansion stage:

About 100-150 subjects are planned to be enrolled The sample size of NSCLC(locally advanced or metastatic G12C mutation) should be ≥ 20 cases. Select 3 or more dose groups for dose expansion,Each dose group needs about 8-50 subjects (adjusted according to the actual situation), including about 8-12 cases conduct pharmacokinetic study. The dose used for the extended test may be an incremental dose, orIt may be the intermediate dose between two incremental doses. During the study period, the researcher based on the facts response evaluation criteria in solid tumors,RECIST 1.1.

Being tested
YL-15293
Keywords
with a KRAS mutation

What participants receive

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

  • YL-15293Drug

    After enrollment, patients will receive oral YL-15293 twice a day until disease progression, unacceptable adverse events, concurrent diseases prevent further study treatment, the investigator decides to withdraw the patient, the patient withdraws consent, the patient is pregnant, or for administrative reasons. After treatment, the patients will continue to be followed up for 30 days. Patients who permanently stop the study treatment for reasons other than disease progression will be followed up for disease evaluation after treatment until the start of new anti-cancer treatment, withdrawal of consent, loss of follow-up, death or until the sponsor stops the study, whichever comes first.

Study groups in NCT05173805
Study groupRoleWhat they receive
YL-15293ExperimentalSingle arm, open, single and multiple doses; Dosage form: YL-15293 tablets Specification: 50mg, 200mg Storage conditions: refrigerated and sealed at 2-8℃ Way of administration: Single-dose study: Oral administration, once a day, with warm water, fasting administration, fasting 1 hour before and 2 hours after administration. Multiple administration studies: oral administration, warm water delivery, fasting administration, fasting 1 hour before administration and 2 hours after administration, continuous administration for 21 days as a treatment cycle. The way of taking the medicine is twice a day.
Receives: Drug: YL-15293

What is being measured

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

  1. 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.

    Measured: Throughout the study for approximately 2 years

  2. Progression free survival, PFS

    PFS, defined as the time from the first dose of study treatment to first

    Measured: Throughout the study for approximately 2 years

  3. Overall survival, OS

    The time from randomization to death for any reason

    Measured: Throughout the study for approximately 2 years

  4. Disease control rate, DCR

    The percentage of cases with remission (PR+CR) and stable lesions (SD) after treatment

    Measured: Throughout the study for approximately 2 years

Timeline

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

  1. First posted30 Dec 2021
  2. Study start30 Jan 2022
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Dec 2024 (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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173805
Sponsor's protocol ID
YL-15293-002
Status last verified
Jan 2023
First submitted
14 Dec 2021
Last updated
18 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YL-15293 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical 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 0 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. 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?

Results are not available in the source record.

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?

The overall response rate (ORR) (time frame: Throughout the study for approximately 2 years). 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 NCT05173805.

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 18 Jul 2023.

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