YL-15293 for Solid Tumors

Recruiting at 2 trial locations

Overseen By Meiyue G Hong, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd.

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: CNS involvement, Active infection, Cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Until disease progression or other criteria

55 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new pill called YY-15293 in patients with a type of lung cancer that has a specific genetic change. The pill aims to stop the cancer from growing by targeting this change. Sotorasib was the first approved treatment for this type of lung cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any concurrent chemotherapy, immunotherapy, or hormonal therapy for cancer treatment.

What safety data exists for YL-15293 or similar treatments in humans?

There is no specific safety data available for YL-15293, but similar treatments like YM155 have been studied for safety in patients with advanced solid tumors, showing that it was generally well-tolerated with a determined maximum tolerated dose. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion 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.

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.

Exclusion Criteria

Subjects who have received prior treatment with KRAS G12C targeted agents.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Dose Escalation

Dose escalation to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of YL-15293

4 weeks

Cycle 1, Day 1 and Day 28 visits for PK sampling

Treatment

Participants receive oral YL-15293 once daily until disease progression or other discontinuation criteria are met

Until disease progression or other criteria

Follow-up

Participants are monitored for safety for 30 days post-treatment and for disease assessment until new anticancer treatment or other criteria

30 days for safety follow-up

Treatment Details

Interventions

• YL-15293

Participant Groups

Group I: YL-15293 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Shanghai YingLi Pharmaceutical Co. Ltd.

Lead Sponsor

Trials

24

Recruited

2,400+

Yingli Pharma US, Inc

Collaborator

Trials

2

Recruited

110+

Findings from Research

In a phase 1 clinical trial involving 108 patients with advanced NSCLC, YK-029A demonstrated a manageable safety profile with no dose-limiting toxicities and common side effects including anemia (50.9%) and diarrhea (49.1%).

Among 28 treatment-naive patients with EGFR exon 20 insertion mutations, YK-029A showed promising efficacy with an objective response rate of 73.1% and a disease control rate of 92.3%, indicating strong antitumor activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK-029A in Treatment-Naive Patients With Advanced NSCLC Harboring EGFR Exon 20 Insertion Mutations: A Phase 1 Trial. Duan, J., Wu, L., Yang, K., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I study of YM155, a novel survivin suppressant, in patients with advanced solid tumors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK-029A in Treatment-Naive Patients With Advanced NSCLC Harboring EGFR Exon 20 Insertion Mutations: A Phase 1 Trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Multicenter phase II trial of YM155, a small-molecule suppressor of survivin, in patients with advanced, refractory, non-small-cell lung cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Action of YM155 on clear cell renal cell carcinoma does not depend on survivin expression levels. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Discovery of YK-029A, a novel mutant EGFR inhibitor targeting both T790 M and exon 20 insertion mutations, as a treatment for NSCLC. [2023]