Advanced Solid TumorPhase 1NCT06078800

A Study of YL-17231 in Patients With Advanced Solid Tumors

A Phase 1 study testing YL-17231 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

This is a phase 1 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-17231 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-17231 and obtain the preliminary efficacy information of patients with advanced… 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?: YL-17231
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 28 Sep 2023to Dec 2025
Phase: Phase 1
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patients must meet all the following inclusion criteria to be eligible for enrollment in this trial:
Age between 18 and 75 years (inclusive), with no gender restriction.
Locally advanced or metastatic solid tumors diagnosed histologically and genomically confirmed with KRAS mutation, excluding patients with a clear KRAS wild-type test report in the case of pancreatic cancer.
For patients with NSCLC, previous treatment failure based on platinum-based first-line therapy; B. For patients with colorectal cancer, previous experience with at least two lines of systemic therapy (patients with colorectal cancer and high microsatellite instability should have received PD-1 or PD-L1 therapy if clinically applicable); C. For patients with solid tumors other than NSCLC or colorectal cancer, at least one prior systemic treatment is required.
In the dose escalation phase, measurable or non-measurable tumor lesions are acceptable based on RECIST1.1 criteria; in the dose expansion phase, at least one measurable tumor lesion is required.
ECOG performance status (PS) of 0-1.

Show all 22Show fewer

Estimated life expectancy of ≥3 months.
Good organ function levels:
Absolute neutrophil count (ANC) ≥1.5×109/L;
Platelet count (PLT) ≥100×109/L;
Hemoglobin (Hb) ≥90g/L (no blood transfusion within 14 days before screening);
Total bilirubin (TBIL) ≤1.5 times the upper limit of normal;
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (≤5.0 times the upper limit of normal for patients with liver metastasis);
Serum creatinine (Cr) ≤1.5 times the upper limit of normal or creatinine clearance ≥50ml/min;
Left ventricular ejection fraction (LVEF) ≥50%;
Fridericia-corrected QT interval (QTcF) <450ms.
Washout period of ≥4 weeks for macromolecular agents and intravenous chemotherapy drugs, and ≥2 weeks for oral fluoropyrimidine and small molecule targeted drugs.
Fertile males and females must agree to use medically approved contraceptive measures during the study period and for 6 months following the last administration of the study drug.
Women of childbearing potential must have a negative pregnancy test within 7 days prior to the first administration of the study drug; patients must not be breastfeeding, and if the subject has already ceased breastfeeding at the time of study entry, breastfeeding must have been discontinued from the day of the first administration of the study drug till at least 30 days after last administration of the study drug .
No previous treatment with investigational drugs within 1 month prior to participation in this trial.
High compliance and willingness to complete the trial as assessed by the investigator, and ability to adhere to the study protocol.
Voluntary participation in this clinical trial, understanding of the study procedures, and ability to provide written informed consent.

Who cannot join

Patients with any of the following conditions are not eligible for enrollment in this study:
Uncontrollable third-space effusion (such as large amounts of pleural or ascitic fluid).
Grade 3 or 4 gastrointestinal bleeding or variceal bleeding requiring transfusion, endoscopy, or surgical intervention within the past 3 months.
Previous diagnosis of other malignancies within the past five years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cured in situ cervical cancer.
Inability to swallow, chronic diarrhea, or intestinal obstruction that could affect medication intake and absorption.
History of significant neurological or psychiatric disorders.

Show all 21Show fewer

Active hepatitis B (positive for hepatitis B surface antigen and/or hepatitis B core antibody with HBV-DNA ≥103 copies/mL or ≥200 IU/mL) or hepatitis C (positive for hepatitis C virus antibody and/or HCV-RNA).
History of immunodeficiency, including positive HIV test, acquired or congenital immunodeficiency disorders, organ transplantation, or allogeneic bone marrow transplantation.
Major surgical procedures (excluding biopsy) within the past 4 weeks prior to the first administration of the study drug, significant trauma, or the need for elective surgery during the study period, or radical radiotherapy within the past 4 weeks prior to the first administration of the study drug.
Moderate or severe cardiac diseases:
Myocardial infarction, angina, III/IV congestive heart failure, pericardial effusion, or uncontrolled severe hypertension (up to 150/90 mmHg or below) within the past 6 months prior to the first administration of the study drug;
Clinically significant electrocardiogram abnormalities, such as symptomatic or persistent atrial or ventricular arrhythmias, second or third-degree atrioventricular block, bundle branch block, or ventricular hypertrophy;
Significant abnormalities on echocardiography, such as moderate or severe valvular dysfunction, assessed based on institutional lower limits; patients with minimal or mild valve regurgitation (tricuspid, pulmonary, mitral, or aortic) can be included in this study;
Various factors that may increase the risk of QTcF prolongation or cardiac arrhythmia events, such as hypokalemia, congenital long QT syndrome, or concomitant use of drugs that may prolong the QT interval.
Untreated brain metastases that meet one or more of the following criteria:
Requiring corticosteroids or dehydration treatment (excluding the use of antiepileptic drugs after surgery or radiotherapy);
Presence of clinically significant symptoms;
Tumor stability after radiotherapy or surgery lasting no longer than 4 weeks. Asymptomatic or controlled stable patients with treated brain metastases are eligible for enrollment.
Unresolved treatment-related toxicity greater than Grade 1 according to CTCAE 5.0 at the start of study treatment (alopecia excluded).
Medical conditions that, in the opinion of the investigator, pose a serious risk to patient safety or could interfere with the patient's ability to complete the study, such as uncontrolled diabetes, thyroid disease, interstitial lung disease, severe active infections, or uncontrolled chronic infections, Child-Pugh Class B or C liver cirrhosis.
Other reasons deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

Xu Ruihua, PhD contact

13922206676

xurh@sysucc.org.cn

China1 site, 1 recruiting

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Xu Ruihua, PhD, xurh@sysucc.org.cn
Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Study on the Safety, Tolerance, Pharmacokinetics and Efficacy of Pan-KRAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors With KRAS Mutation

Read the detailed description

The study will be conducted in China to provide safety, efficacy and PK data. A dose escalation part 1 will be conducted to determine the MTD, DLTs, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-17231 given twice daily, in patients with advanced solid tumors to obtain preliminary efficacy information. PK samplings at single dose stage Day 1 and at steady-state conditions (Cycle 1, Day 14) will be performed.

Conditions: Advanced Solid Tumor
Being tested: YL-17231
Keywords: Nonsmall-cell lung cancer（NSCLC）, Colorectal cancer（CRC）, Pancreatic carcinoma, KRAS mutation
Medical subject headings: Pancreatic Neoplasms

What participants receive

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

YL-17231Drug
Also called Pan-KRAS Inhibitor YL-17231
After a screening period of approximately 14 days, eligible patients will receive oral YL-17231 once or twice daily until documented disease progression, unacceptable AEs, intercurrent illness preventing further administrations of study treatment, investigator's decision to withdrawal, the patient's consent of withdrawal, pregnancy, 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's consent of withdrawal, lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.

Study groups in NCT06078800
Study group	Role	What they receive
YL-17231	Experimental	YL-17231 will be administrated orally from 0.25mg QD, 0.5mg BID to 10mg BID in sequence during dose excalation part and selected doses in dose expansion part,for 21 consecutive days as a treatment cycle Receives: Drug: YL-17231

What is being measured

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

DLTs
Dose limited toxicities
Measured: At the end of Cycle 1 (each cycle is 21 days)
TEAEs
Treatment emergent adverse events
Measured: From day 1 after taking the investigational product till 30 days after withdrawal from the study

Secondary outcomes (9)

Cmax
Peak plasma concentration
Measured: From day 1 to the end of Cycle 2 (each cycle is 21 days)
AUC
Area under the plasma concentration versus time curve
Measured: From day 1 to the end of Cycle 2 (each cycle is 21 days)
Tmax
Time to maximum plasma concentration
Measured: From day 1 to the end of Cycle 2 (each cycle is 21 days)
T1/2
Elimination half-life
Measured: From day 1 to the end of Cycle 2 (each cycle is 21 days)
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: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
DOR
Duration of response
Measured: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Disease control rate, DCR
The percentage of cases with remission (PR+CR) and stable lesions (SD) after treatment
Measured: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Progression free survival, PFS
PFS, defined as the time from the first dose of study treatment to first documented progression
Measured: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Overall survival, OS
The time from randomization to death for any reason
Measured: From date of screening until the date of death from any cause, assessed up to 36 months

Timeline

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

28 Sep 2023Dec 2025

First posted12 Oct 2023
Study start28 Sep 2023
Primary completionMar 2025 (estimated)
Study completionDec 2025 (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: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06078800
Sponsor's protocol ID: YL-17231-002
Status last verified: Oct 2023
First submitted: 27 Sep 2023
Last updated: 12 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Xu Ruihua, PhD

13922206676

xurh@sysucc.org.cn

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?

See locations

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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study on the Safety, Tolerance, Pharmacokinetics and Efficacy of Pan-KRAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors With KRAS Mutation
ClinicalTrials.gov ID: NCT06078800
Acronym / sponsor ID: YL-17231-002
Conditions: Advanced Solid Tumor
Keywords: Nonsmall-cell lung cancer（NSCLC）, Colorectal cancer（CRC）, Pancreatic carcinoma, KRAS mutation
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Study start: 28 Sep 2023 (actual)
Primary completion: Mar 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 12 Oct 2023 (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.

Detailed description

Study design

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

Arm	Type	Receives
YL-17231	Experimental	Drug: YL-17231YL-17231 will be administrated orally from 0.25mg QD, 0.5mg BID to 10mg BID in sequence during dose excalation part and selected doses in dose expansion part,for 21 consecutive days as a treatment cycle

Who may qualify

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

Key inclusion criteria (22 listed)

The patients must meet all the following inclusion criteria to be eligible for enrollment in this trial:
Age between 18 and 75 years (inclusive), with no gender restriction.
Locally advanced or metastatic solid tumors diagnosed histologically and genomically confirmed with KRAS mutation, excluding patients with a clear KRAS wild-type test report in the case of pancreatic cancer.
In the dose escalation phase, measurable or non-measurable tumor lesions are acceptable based on RECIST1.1 criteria; in the dose expansion phase, at least one measurable tumor lesion is required.
ECOG performance status (PS) of 0-1.

Key exclusion criteria (21 listed)

Patients with any of the following conditions are not eligible for enrollment in this study:
Uncontrollable third-space effusion (such as large amounts of pleural or ascitic fluid).
Grade 3 or 4 gastrointestinal bleeding or variceal bleeding requiring transfusion, endoscopy, or surgical intervention within the past 3 months.
Previous diagnosis of other malignancies within the past five years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cured in situ cervical cancer.
Inability to swallow, chronic diarrhea, or intestinal obstruction that could affect medication intake and absorption.

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
YL-17231Also: Pan-KRAS Inhibitor YL-17231After a screening period of approximately 14 days, eligible patients will receive oral YL-17231 once or twice daily until documented disease progression, unacceptable AEs, intercurrent illness preventing further administrations of study treatment, investigator's decision to withdrawal, the patient's consent of withdrawal, pregnancy, 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's consent of withdrawal, lost to follow-up, death, or until the Sponsor stops the study, whichever comes first.	Drug	YL-17231

Primary outcome

DLTs
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Dose limited toxicities
TEAEs
Time frame: From day 1 after taking the investigational product till 30 days after withdrawal from the study
Treatment emergent adverse events

9 secondary outcomes

Cmax
Time frame: From day 1 to the end of Cycle 2 (each cycle is 21 days)
AUC
Time frame: From day 1 to the end of Cycle 2 (each cycle is 21 days)
Tmax
Time frame: From day 1 to the end of Cycle 2 (each cycle is 21 days)
T1/2
Time frame: From day 1 to the end of Cycle 2 (each cycle is 21 days)
The overall response rate (ORR)
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
DOR
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Disease control rate, DCR
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Progression free survival, PFS
Time frame: From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Overall survival, OS
Time frame: From date of screening until the date of death from any cause, assessed up to 36 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.

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. This study is not recruiting at the moment.

Xu Ruihua, PhD contact

13922206676

xurh@sysucc.org.cn

Xu Ruihua, PhD principal investigator

Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YL-17231 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 22 inclusion and 21 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 12 Oct 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 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?

Results are not available in the source record.

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

Contact Xu Ruihua, PhD (13922206676, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (time frame: At the end of Cycle 1 (each cycle is 21 days)). 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 NCT06078800.

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 12 Oct 2023.