A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Beijing Pearl Biotechnology Limited Liability Company
Study ID
NCT07285148
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ANS014004 + PLB1004 — DRUG
    1. Drug: ANS014004 Investigational Type II MET tyrosine kinase inhibitor (oral tablets). Dosing: Phase Ib escalation (30 mg, 45 mg, 60 mg, 75 mg QD); optimization uses selected doses; Phase II uses RP2D. Administered QD (≥1h before/2h after meals) in 21-day cycles. Targets MET exon 14 skipping, amplification, overexpression, and fusions. 2. Drug: PLB1004 Investigational irreversible EGFR tyrosine kinase inhibitor (oral capsules). Fixed dose: 80 mg QD. Administered QD (≥1h before/2h after meals) in 21-day cycles. Targets EGFR classical mutations (Ex19del, L858R), rare mutations, Ex20ins, and T790M.
  • ANS014004 + Osimertinib — DRUG
    1. Drug: ANS014004 (Same description as above, as the drug is identical across arms). 2. Drug: Osimertinib Market-approved third-generation EGFR tyrosine kinase inhibitor (oral tablets). Dosing: Per reference label (QD, with/without meals). Administered in 21-day cycles. Targets EGFR classical mutations (Ex19del, L858R) and T790M. Used as an active comparator.

Study Details

Protocol Title A Study to Evaluate ANS014004 in Combination with EGFR-TKI in Patients with EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer The main purpose of this research study is to Find a safe and tolerable dose of two investigational drugs, ANS014004 and PLB1004, when used together. Learn how effective this drug combination is at treating a type of lung cancer called "EGFR mutation-positive non-small cell lung cancer (NSCLC)" that has spread to other parts of the body (locally advanced or metastatic). This study is trying to answer the following questions: Safety \& Dosing: What are the side effects of combining ANS014004 and PLB1004? What is the best dose to use that patients can tolerate well? Effectiveness: Can this combination of drugs help shrink patients' tumors or stop them from growing? Background Information For patients with advanced lung cancer that has a specific gene change called an "EGFR mutation," targeted therapies known as EGFR-TKIs are a standard treatment. While these treatments often work well at first, most tumors eventually stop responding to the drug (this is called "acquired resistance"). The investigational drug ANS014004 is designed to block a protein called MET, which is one of the ways that tumors become resistant to EGFR-TKIs. The researchers believe that by combining ANS014004 with the EGFR-TKI PLB1004, they may be able to prevent or delay resistance, offering patients a more effective and longer-lasting treatment option. How will the study be conducted? This study is divided into two parts: Part 1 (Dose Escalation and Optimization): A small number of participants will receive different dose levels of ANS014004 combined with a fixed dose of PLB1004. The goal is to find the safest and most tolerable dose combination. Part 2 (Phase II Study): Once a recommended dose is identified, more participants will be enrolled to further evaluate how well the drug combination works against the cancer. Throughout the study, participants' health will be closely monitored, and their tumors will be measured regularly using imaging scans (like CT scans) to see how they respond to the treatment.

Key Dates

Start date
Jun 30, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
253 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ANS014004+PLB1004
    The Phase Ib study consists of two parts: dose escalation and dose optimization. The dose escalation part will enroll participants with EGFR mutation-positive locally advanced or metastatic NSCLC who have received prior standard therapy in order to evaluate the safety and tolerability of the combination therapy and determine the maximum tolerated dose (MTD) (if any); The dose optimization part will further expand the population to include participants with EGFR mutation-positive locally advanced or metastatic NSCLC who have not received prior systemic therapy for advanced disease or have received standard therapy to determine the recommended Phase 2 dose (RP2D).
  • Active Comparator: ANS014004 + Osimertinib
    participants will be enrolled in into two cohorts according to the prior anti-tumor treatment received. * Cohort A: participants with EGFR mutation-positive (excluding exon 20 insertions) locally advanced or metastatic NSCLC who have not received prior standard systemic therapy for advanced disease. Participants who meet the inclusion criteria will be stratified according to baseline brain metastasis status (present vs. absent) and be randomized at a ratio of 2:1 to receive the combination treatment of ANS014004 and PLB1004 or the combination treatment of ANS014004 and Osimertinib. * Cohort B: participants with EGFR mutation-positive (excluding exon 20 insertions) locally advanced or metastatic NSCLC who previously received standard systemic therapy. Participants who meet the inclusion criteria will be stratified according to baseline MET amplification and/or overexpression status (present vs. absent) and be randomized at a ratio of 2:1 to receive the combination treatment of ANS0140

Primary Outcome Measure

Number of participants with dose-limiting toxicity (DLT) during the DLT observation period (Phase Ib Dose Escalation) [ Time Frame: 2 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center David H, Koch Center lor Cancer CareNew YorkNew York10021
Helena Yu
[email protected]
646-608-3912

Find similar trials in New York, NY

By condition
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By specialty
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By research site
Memorial Sloan Kettering Cancer Center David H, Koch Center lor Cancer Care· New York, NY

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