A Phase 1/2, Study of YL-15293 in Subjects With Advanced Solid Tumors With a KRAS G12C Mutation

NCT05119933 | Unknown Phase 1 FDA Drug

• 1 other identifier: YL-15293-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief 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 with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation.

Conditions

Advanced Solid Tumor

Keywords

with a KRAS G12C mutation

Outcome Measures

Primary Outcomes (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.

  Throughout the study for approximately 2 years

Secondary Outcomes (3)

• Progression free survival, PFS

  Throughout the study for approximately 2 years

• Overall survival, OS

  Throughout the study for approximately 2 years

• Disease control rate, DCR

  Throughout the study for approximately 2 years

Study Arms (1)

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.

Drug: YL-15293

Interventions

YL-15293 DRUG

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.

YL-15293

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead
• Yingli Pharma US, Inc: collaborator

Study Sites (3)

Innovative Clinical Research Institute

Whittier, California, 90603, United States

NOT YET RECRUITING

The Tisch Cancer Institute Mount Sinai Health System Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

Oncology Consultants

Houston, Texas, 77584, United States

RECRUITING

Central Study Contacts

Meiyue G Hong, M.D.

CONTACT

myhong@yl-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 15, 2021
• Study Start: November 9, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 15, 2021

Record last verified: 2021-09

Locations

US (3)