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New treatment option for Solid Tumors
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 Oral Capsules?
APL-101 Oral Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumors.
Also referred to as PLB-1001, CBI-3103.
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
- To assess: efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)
- 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.
- 9 cohorts will be enrolled:
- Cohort A1 / Exon 14 NSCLC MET inhibitor naive in first line: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all...
- Cohort A2 / Exon 14 NSCLC - MET inhibitor naïve: Histologically or cytologically confirmed NSCLC with Exon 14 skipping mutations; all histologies...
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.
- 9 cohorts will be enrolled:
- 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); pretreated people...
- 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...
- 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...
- 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; unresectable or metastatic disease, refractory to or intolerant of...
- 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; Unresectable or...
- 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
- History of another malignancy within 3 years prior to C1D1. A subject with the following malignancies is allowed if considered cured or unlikely to recur within 3 years:
- 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. people who have been receiving a stable steroid dose for at least 2 weeks prior to C1D1 may...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, 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
+ 12 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 - 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?
Study sites include Los Angeles, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Chapel Hill, North Carolina, United States; Hershey, Pennsylvania, United States; Madison, Wisconsin, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.