APL-101 for Advanced Solid Tumors with c-Met Mutations
This study is testing a drug called APL-101 in people with advanced solid tumors, including non-small cell lung cancer (NSCLC), renal cancer, gastric cancer, and gastroesophageal junction adenocarcinoma. APL-101 is a kinase inhibitor, meaning it blocks certain proteins that can help cancer grow. You might be able to join if you are 18 or older and have specific genetic changes in your tumor, such as c-Met Exon 14 skip mutations or c-Met dysregulation. The study aims to see how many people respond to APL-101 (objective response rate) based on tumor shrinkage or disappearance, measured from when you join until treatment ends or the cancer progresses. The study is currently unclear on its recruitment status, but the Phase 1 part is complete.
- Study design
- This is an interventional study, meaning participants receive a specific treatment. It is a Phase 2 study, and it plans to enroll 497 participants.
- What's involved
- Participants will take APL-101 capsules by mouth twice a day. The treatment cycle is 28 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured from the time you sign the consent form through the completion of treatment or until your cancer progresses.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03175224
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Recruiting
PHASE2Ages 18+InterventionalTreatmentApollomics Inc.
~497 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:APL-101 Oral Capsules
At a glance
Recruiting sites
32 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)
Measured over From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression
Conditions
Where it's being run
35 sites across 16 statesSpain6
France5
Italy5
Canada4
United Kingdom3
Hungary2
California1
Florida1
Study leadership
- Mythili Sangem · STUDY_DIRECTOR · Apollomics Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); treatment-naive subjects in first line; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
Cohort A2 / Exon 14 NSCLC - MET inhibitor naïve: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies; unresectable or metastatic disease (Stage 3b/4); pretreated subjects refractory to or intolerant of standard therapies with no more than three lines of prior therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
Cohort B / Exon 14 NSCLC MET inhibitor experienced: ENROLLMENT COMPLETED
Cohort C / MET amplification basket tumor types excluding primary CNS tumors: Any solid tumor type regardless of histology excluding primary CNS tumors, with MET amplification; unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
Cohort C1 / MET amplification and wild-type EGFR NSCLC: NSCLC regardless of histology, harboring MET amplification and wild-type EGFR; unresectable or metastatic disease, previously untreated or treated with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
Cohort C2 / EGFR positive NSCLC with acquired MET amplification (APL-101 Add-on Therapy): Unresectable or metastatic NSCLC regardless of histology, harboring EGFR activating mutations with acquired MET-Amplification as resistance mechanism to the EGFR-I; developed resistance to first-line EGFR-inhibitor therapy after an initial response (documented PR for at least 12 weeks); radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy; currently on an EGFR-inhibitor therapy and agrees to receive APL-101 as an add-on therapy during the study; no history of interstitial lung disease (ILD)/pneumonitis, Grade ≥3 liver toxicity or QT prolongation with EGFR-I therapy; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
Cohort D / MET fusion basket tumor types excluding primary CNS tumors: any solid tumor type regardless of histology excluding primary CNS tumors; unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations
Cohort F / Basket tumor types harboring wild-type MET with over-expression of HGF and MET: any solid tumor type regardless of histology harboring wild-type MET with overexpression of HGF and MET; Unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavailable or unfeasible, with no more than 3 prior lines of therapy in the unresectable or metastatic setting; not received any MET inhibitor and no known MET kinase inhibitor resistance mutations 3. Treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed. 4. Presence of ≥1 measurable lesion (scan done ≤28 days of C1D1) to serve as target lesion according to relevant criteria 5. ECOG performance status of 0-1. For subjects with primary CNS tumors, KPS score ≥70. 6. Acceptable organ function 7. For all prior anticancer treatment, a duration of 30 days or 5 half-lives of the agents used, whichever is shorter, must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria prior to the first dose of study treatment. Palliative radiotherapy to non-target lesions should be completed within 2 weeks prior to APL-101 administration. 8. Adequate cardiac function 9. Women of child-bearing potential must have a negative serum or Beta-hCG at screening or evidence of surgical sterility or evidence of post-menopausal status 10. No planned major surgery within 4 weeks of first dose of APL-101 11. Expected survival (life expectancy) ≥ 3 months from C1D1 12. Provision of sample; e.g. archival or a fresh tumor biopsy sample (if safe and feasible) either from the primary or a metastatic site) or liquid biopsy sample (if tumor tissue is insufficient or lacking, and approved by the sponsor) is required for prospective central lab confirmation for study entry (subjects with previously confirmed molecular status by the Sponsor designated central lab or FDA approved NGS based MET testing may be exempted, subjected to Sponsor approval.
What this trial measures
- Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression
Anti-tumor activity per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.