A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation
NCT ID: NCT05119933
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2021-11-09
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
YL-15293
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.
YL-15293
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
YL-15293
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. 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.
2. Measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1.
3. Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 14 days of treatment initiation.
4. Has a performance status of 0-2 on the ECOG Performance scale.
5. Life expectancy more than12 weeks at baseline.
6. 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.
7. 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.
8. 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.
9. Age more than18 years at screening.
10. Able and willing to provide written informed consent and to follow study instructions.
Exclusion Criteria
The patient will be excluded from participating in the trial if meet any of the following:
1. Patient has disease that is suitable for therapy administered with curative intent.
2. Subjects who have received prior treatment with KRAS G12C targeted agents.
3. 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:
1. Patient has disease that is suitable for therapy administered with curative intent.
2. Subjects who have received prior treatment with KRAS G12C targeted agents or pan-KRAS inhibitors.
3. Subjects who have received 4 or more lines of prior therapy.
4. Central nervous system (CNS) involvement with tumor.
5. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
6. 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.
7. Patient has an active infection requiring systemic therapy.
8. 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.
9. 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.
10. Patient has a history of interstitial lung disease.
11. 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.
12. Participation in another clinical trial of an investigational agent within 30 days of screening.
13. 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.
14. 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yingli Pharma US, Inc
UNKNOWN
Shanghai YingLi Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Innovative Clinical Research Institute
Whittier, California, United States
The Tisch Cancer Institute Mount Sinai Health System Icahn School of Medicine at Mount Sinai
New York, New York, United States
Oncology Consultants
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Merrill Shum, M.D.
Role: primary
Christian Rolfo, MD, Ph.D., MBA, Dr.hc.
Role: primary
Julio A Peguero, M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YL-15293-001
Identifier Type: -
Identifier Source: org_study_id