Advanced Solid TumorPhase 1/2NCT05119933
A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation
A Phase 1/2 study testing YL-15293 in people with Advanced Solid Tumor, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 3 sites in United States.
Trial summary
This is a Phase 1/2, open-label, multicenter study designed to evaluate the maximum tolerated, safety, tolerability and PK of oral YY-15293 in patients with advanced solid tumors with a KRAS G12C mutation, to confirm the recommended phase 2 dose of YY-15293, and to obtain preliminary efficacy information in patients… 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
- 55 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Nov 2021to 1 Dec 2023
- 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
- In order to be eligible for participation in this trial, the patient must meet all the following criteria:
- Part 1 only - metastatic or locally advanced solid tumor malignancies positive for KRAS G12C that has progressed on, is refractory to, intolerant to, or for which there is no curative standard of care therapy.
- Part 2 only - metastatic or locally advanced KRAS G12C NSCLC for patients for whom there is no curative standard of care therapy.
- Measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1.
- Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 14 days of treatment initiation.
- Has a performance status of 0-2 on the ECOG Performance scale.
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- Life expectancy more than12 weeks at baseline.
- Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day study drug administration.
- Male patients of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.
- Age more than18 years at screening.
- Able and willing to provide written informed consent and to follow study instructions.
Who cannot join
- Patients are excluded from the study if any of the following criteria apply:
- The patient will be excluded from participating in the trial if meet any of the following:
- Patient has disease that is suitable for therapy administered with curative intent.
- Subjects who have received prior treatment with KRAS G12C targeted agents.
- Subjects who have received 4 or more lines of prior therapy.
- The patient will be excluded from participating in the trial if meet any of the following:
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- Patient has disease that is suitable for therapy administered with curative intent.
- Subjects who have received prior treatment with KRAS G12C targeted agents or pan-KRAS inhibitors.
- Subjects who have received 4 or more lines of prior therapy.
- Central nervous system (CNS) involvement with tumor.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior therapy, defined as having not resolved to NCI CTCAE v.5.0 Grade 0 or 1, with exception of endocrinopathies from prior therapy and successfully treated (such as hypothyroidism), as well as alopecia and vitiligo.
- Patient has an active infection requiring systemic therapy.
- Patients who have known active HIV, Hepatitis or Hepatitis or active COVID-19 infection. (Patients who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study). Subjects who are positive for HIV or hepatitis B or C virus must be tested for and have an undetectable viral load.
- Patients with unstable/inadequate cardiac function:
- New York Heart Association Class 3 or 4 congestive heart failure, Uncontrolled hypertension, Acute coronary syndrome within 6 months, Clinically significant cardiac arrhythmia, Mean QTC interval corrected for heart rate >500ms.
- Patient has a history of interstitial lung disease.
- Current active additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Participation in another clinical trial of an investigational agent within 30 days of screening.
- Patient has known psychiatric, substance abuse or other disorders that would interfere with cooperation with the requirements of the trial, in the opinion of the investigator.
- Patients who are pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Trial locations and contacts
3 sites in 1 country.
Meiyue G Hong, M.D. contact
United States3 sites, 3 recruiting
- Recruiting
Oncology Consultants
Houston, Texas, 77584
Julio A Peguero, M.D., 713-600-0913, jpeguero@oncologyconsultants.com
- Not yet recruiting
The Tisch Cancer Institute Mount Sinai Health System Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Christian Rolfo, MD, Ph.D., MBA, Dr.hc.
- Not yet recruiting
Innovative Clinical Research Institute
Whittier, California, 90603
Merrill Shum, M.D.
About this study
Official title: A Phase 1/2, Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation
This is a Phase 1/2, open-label, multicenter study designed to evaluate the maximum tolerated, safety, tolerability and PK of oral YY-15293 in patients with advanced solid tumors with a KRAS G12C mutation, to confirm the recommended phase 2 dose of YY-15293, and to obtain preliminary efficacy information in patients with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
Read the detailed description
The study will be conducted in the United States of America (USA) and China to provide safety, efficacy and PK data from these regions. A dose escalation part 1 will be conducted to determine the MTD, DLT's, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-15293 given once daily, in patients with advanced NSCLC to obtain preliminary efficacy information. PK samplings at Cycle 1, Day 1 and at steady-state conditions (Cycle 1, Day 28) will be performed. PD evaluations will occur at cycle 1 and cycle 2.
- Conditions
- Advanced Solid Tumor
- Being tested
- YL-15293
- Keywords
- with a KRAS G12C mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL-15293Drug
After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once 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 (see Section 7.1). 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.
| Study group | Role | What they receive |
|---|---|---|
| YL-15293 | Experimental | After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once 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: YL-15293 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (3)
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
Overall survival, OS
The time from randomization to death for any reason
Measured: Throughout the study for approximately 2 years
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.
- First posted15 Nov 2021
- Study start9 Nov 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yingli Pharma US, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119933
- Sponsor's protocol ID
- YL-15293-001
- Status last verified
- Sep 2021
- First submitted
- 11 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT05119933
- Acronym / sponsor ID
- YL-15293-001
- Conditions
- Advanced Solid Tumor
- Keywords
- with a KRAS G12C mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Yingli Pharma US, Inc
- Study start
- 9 Nov 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Nov 2021 (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.
This is a Phase 1/2, open-label, multicenter study designed to evaluate the maximum tolerated, safety, tolerability and PK of oral YY-15293 in patients with advanced solid tumors with a KRAS G12C mutation, to confirm the recommended phase 2 dose of YY-15293, and to obtain preliminary efficacy information in patients with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.
Detailed description
The study will be conducted in the United States of America (USA) and China to provide safety, efficacy and PK data from these regions. A dose escalation part 1 will be conducted to determine the MTD, DLT's, and part 2 will confirm the safety/tolerability of the recommended Phase 2 dose (RP2D), of YL-15293 given once daily, in patients with advanced NSCLC to obtain preliminary efficacy information. PK samplings at Cycle 1, Day 1 and at steady-state conditions (Cycle 1, Day 28) will be performed. PD evaluations will occur at cycle 1 and cycle 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YL-15293 | Experimental | Drug: YL-15293After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- In order to be eligible for participation in this trial, the patient must meet all the following criteria:
- Part 2 only - metastatic or locally advanced KRAS G12C NSCLC for patients for whom there is no curative standard of care therapy.
Key exclusion criteria (21 listed)
- Patients are excluded from the study if any of the following criteria apply:
- The patient will be excluded from participating in the trial if meet any of the following:
- Patient has disease that is suitable for therapy administered with curative intent.
- Subjects who have received prior treatment with KRAS G12C targeted agents.
- Subjects who have received 4 or more lines of prior therapy.
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-15293After a screening period of approximately 28 days, eligible patients will receive oral YL-15293 once 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 (see Section 7.1). 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. | Drug | YL-15293 |
Primary outcome
The overall response rate (ORR)
Time frame: Throughout the study for approximately 2 years
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.
3 secondary outcomes
Progression free survival, PFS
Time frame: Throughout the study for approximately 2 years
Overall survival, OS
Time frame: Throughout the study for approximately 2 years
Disease control rate, DCR
Time frame: Throughout the study for approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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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.
Meiyue G Hong, M.D. contact
3 sites in 1 country: see every site and its status.
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 3 sites in United States.
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 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Contact Meiyue G Hong, M.D. (myhong@yl-pharma.com), or a site near the patient. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.