Solid Tumors study: APL-101 Oral Capsules
Official title APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03175224
What this study is testing
What is APL-101?
APL-101 is an investigational oral capsule being studied as a potential treatment for various solid tumors, including certain types of lung cancer and other cancers with MET alterations.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if APL-101 works alone or with an EGFR drug in patients whose tumors have MET exon 14 skipping, MET amplification, MET fusion, or high HGF/MET levels, and in some lung cancers that have become resistant to EGFR inhibitors.
- Who it's for
- Adults with advanced solid tumors, especially lung cancer, that have the specified MET or EGFR gene changes.
- What's involved
- Participants will receive APL-101, either by itself or together with an EGFR inhibitor, and will have regular clinic visits, blood tests, and imaging scans to monitor the tumor and any side effects.
- Time commitment
- The study lasts several months, with visits every few weeks for treatment, monitoring, and follow‑up.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Major
- Men and women 18 years of age or older.
- Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations
- Cohort A2 / Exon 14 NSCLC - MET inhibitor naïve: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies
- Cohort B / Exon 14 NSCLC MET inhibitor experienced: ENROLLMENT COMPLETED
You likely can't join if
- Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
- Known actionable mutation/gene rearrangement of EGFR (except for NSCLC people in Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
- Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination.
- Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the...
- Life-threatening illness, significant organ system dysfunction or comorbid conditions, or other reasons that, in the investigator's opinion, could...
- Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical therapy...
See the full eligibility criteria
Who can join
- Major
- Men and women 18 years of age or older.
- 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)
- 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)
- 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
- Cohort C1 / MET amplification and wild-type EGFR NSCLC: NSCLC regardless of histology, harboring MET amplification and wild-type EGFR
- 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...
- Cohort D / MET fusion basket tumor types excluding primary CNS tumors: any solid tumor type regardless of histology excluding primary CNS tumors
- Cohort E / Primary CNS tumors with MET alterations: people with primary CNS tumors who meet of MET dysregulations defined as single or co-occurred MET fusion including PTPRZ1-MET (ZM) fusion, MET Exon 14 skipping...
- 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
- Treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed.
- Presence of ≥1 measurable lesion (scan done ≤28 days of C1D1) to serve as target lesion according to relevant criteria
- ECOG performance status of 0-1. For people with primary CNS tumors, KPS score ≥70.
- Acceptable organ function
- 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...
- Adequate cardiac function
- 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
- No planned major surgery within 4 weeks of first dose of APL-101
- Expected survival (life expectancy) ≥ 3 months from C1D1
- 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...
What rules you out
- Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
- Known actionable mutation/gene rearrangement of EGFR (except for NSCLC people in Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
- Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination.
- Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the investigator makes the risk: benefit unfavorable for the participation of...
- Life-threatening illness, significant organ system dysfunction or comorbid conditions, or other reasons that, in the investigator's opinion, could compromise the subject's safety or the integrity of the study outcomes...
- Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical therapy, history of congenital prolonged QT syndrome, prolonged QT interval...
- Historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) with high viral loads not actively managed with antiviral therapy and human immunodeficiency virus...
- Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol...
- Unable to swallow orally administered medication whole.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption
- Women who are breastfeeding
- Carcinoma of the skin without melanomatous features.
- Curatively treated cervical carcinoma in situ.
- Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (T1s), thyroid papillary cancer with prior treatment, prostate cancer which has been surgically or medically treated and not likely...
- people who are unable or unwilling to discontinue excluded medications (drugs with known QTc risk and known strong cytochrome P450 [CYP]3A4 inducer and/or strong inhibitors) for at least 5 half-lives prior to first dose...
- people with active COVID-19 infection.
- Symptomatic and/or neurologically unstable CNS metastases, or who require an increase in steroid dose to control CNS disease.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Chapel Hill, North Carolina, United States
- Hershey, Pennsylvania, United States
- Madison, Wisconsin, United States
- Melbourne, Australia
- Edmonton, Canada
- Montreal, Canada
- Toronto, Canada
- Winnipeg, Canada
- Brest, France
- Lyon, France
- Marseille, France
- Paris, France
- Villejuif, France
- Budapest, Hungary
- Tatabánya, Hungary
- Bologna, Italy
- Meldola, Italy
- Milan, Italy
- Padova, Italy
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Chapel Hill, North Carolina, United States; Hershey, Pennsylvania, United States; Madison, Wisconsin, United States; Melbourne, Australia; Edmonton, Canada and 23 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.