A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer (NCT07285148) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer
United States253 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female participants ≥18years of age at the time of signing the informed consent form.
✓. Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) NSCLC (according to the lung cancer staging criteria, refer to the eighth edition of the American Joint Committee on Cancer \[AJCC\] Lung Cancer Staging).
✓. Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples or pleural fluid or blood samples.
✓. For Phase Ib dose escalation: have disease progression after the existing standard of care or intolerance to the existing standard of care or inappropriate or no effective standard of care is available (standard of care is defined as treatment recommended by the National Comprehensive Cancer Network \[NCCN\] guidelines \[including but not limited to chemotherapy, radiotherapy, targeted therapy based on mutation status, immunotherapy, and surgery\]). For participants who are considered intolerant to or ineligible for available standard therapy, or for whom effective standard therapy does not exist, the documentation of these reasons is required.
✓. For China only: the presence of MET amplification and/or overexpression in tumor tissue samples or pleural fluid or blood samples collected after progression on prior EGFR-TKI treatment, confirmed by a central /local laboratory.
✓
What they're measuring
1
Number of participants with dose-limiting toxicity (DLT) during the DLT observation period (Phase Ib Dose Escalation)
Timeframe: 2 years.
2
Maximum tolerated dose (MTD) of ANS014004 in combination with PLB1004 (Phase Ib Dose Escalation)
Timeframe: 2 years
3
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 (Phase Ib Dose Optimization, Phase II)
Timeframe: 2 years
4
Recommended Phase 2 Dose (RP2D) of ANS014004 in combination with PLB1004 (Phase Ib Dose Optimization)
Timeframe: 2 years.
Trial details
NCT IDNCT07285148
SponsorBeijing Pearl Biotechnology Limited Liability Company
. Have at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. ECOG PS ≤ 1.
✓. Life expectancy of ≥12 weeks, in the opinion of the investigator.
Exclusion criteria
✕. Have other known primary driver gene alterations. For example, NSCLC with a targetable alteration in ALK, RET, ROS1, BRAF, KRAS, etc. The investigators should discuss enrollment with the sponsor regarding co-mutations.
✕. Prior treated with hepatocyte growth factor (HGF) targeted therapy or other MET-TKIs (including Type I and Type II), e.g., gulmonertinib, savolitinib, capmatinib, tepotinib, bozitinib, cabozantinib, glenitinib and almonertinib.
✕. Participation in other therapeutic clinical trials within 28 days prior to the first dose of study treatment.
✕. Received anti-tumor therapy (chemotherapy, immunotherapy, hormone therapy, targeted therapy, biological therapy or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, and agonists required to inhibit serum testosterone levels) within 14 days or 5 half-lives (whichever is shorter) of the first dose of study treatment. The following exceptions are:
✕. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment.
✕. Major surgery, other than diagnostic surgery, within 4 weeks of the first study treatment or is expected during the study.
✕. Toxicities of prior therapy have not been resolved to Grade ≤1 or to baseline, as evaluated by NCI-CTCAE v5.0. NOTE: Participants with Grade 2 toxicities can be enrolled if the toxicities as stable and do not affect the safety of participating in this study (e.g., alopecia, skin hyperpigmentation, neuropathy).
✕. History of another primary malignancy that has been diagnosed or required therapy within the past 3 years (other than adequately treated local basal cell or squamous cell carcinoma of the skin; or any other cancer in situ currently in complete remission).