APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors (SPARTA)

October 19, 2023 updated by: Apollomics Inc.

Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

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)

Study Overview

Detailed Description

Phase 1 (lead-in stage of this study) enrollment has been completed.

In this Phase 2 study, efficacy, safety, and tolerability will be assessed in the following cohorts:

  • Cohort A-1: NSCLC EXON 14 skip mutation, previously untreated, MET inhibitor naive (c-Met naïve, 1L)
  • Cohort A-2: NSCLC EXON 14 skip mutation, previously treated with ≤ 3 prior lines in unresectable or metastatic setting, MET inhibitor naive (c-Met naïve, 2/3L)
  • Cohort B: NSCLC EXON 14 skip mutation, previously treated with ≤ 3 prior lines in unresectable or metastatic setting, MET inhibitor experienced (c-Met experienced; progressed on prior c-Met inhibitor)
  • Cohort C: basket of tumor types (e.g., NSCLC, upper gastrointestinal [GI], colorectal, hepatobiliary cancer) harboring MET amplification except for primary CNS tumors, previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
  • Cohort C-1: NSCLC harboring MET amplification and wild-type epidermal growth factor receptor (EGFR), previously treated; or untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
  • Cohort C-2: EGFR positive NSCLC harboring MET amplification as an acquired resistance, documented response with first-line EGFR-Inhibitor (PR or CR per RECIST ≥ 12 weeks), radiological documentation of disease progression per RECIST on first-line EGFR inhibitor therapy, MET inhibitor naïve
  • Cohort D: basket of tumor types except for primary CNS tumors harboring MET gene fusions (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer), previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve
  • Cohort E: primary CNS tumors with MET alterations (single or co-occurred MET fusion including PTPRZ1-MET [ZM] fusion, MET Exon 14 skipping mutation, or MET amplification), previously treated or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines), MET inhibitor naïve
  • Cohort F: basket of tumor types harboring wild-type MET with over-expression of HGF and MET (e.g., NSCLC, upper GI, colorectal, hepatobiliary cancer or primary CNS tumors), previously treated; or previously untreated but refused standard treatment, or if treatment was unavailable or unfeasible (≤ 3 prior lines in unresectable or metastatic setting), MET inhibitor naïve

Study Type

Interventional

Enrollment (Estimated)

497

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Albury, Australia
        • Recruiting
        • Border Medical Oncology
      • Frankston, Australia
        • Recruiting
        • Peninsula and Southeast Oncology
      • Melbourne, Australia
        • Recruiting
        • St Vincents Hospital Melbourne
      • Nedlands, Australia
        • Recruiting
        • Sir Charles Gairdner Hospital
      • North Adelaide, Australia
        • Active, not recruiting
        • Calvary Central Districts Hospita
    • South Australia
      • Bedford Park, South Australia, Australia
        • Recruiting
        • Flinders Medical Centre
      • Edmonton, Canada
        • Recruiting
        • Cross Cancer Institute
      • Montréal, Canada
        • Recruiting
        • McGill University Health Center - Research Institute
      • Toronto, Canada
        • Recruiting
        • Princess Margaret Hospital
      • Winnipeg, Canada
        • Recruiting
        • Cancer Care Manitoba
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Lady Davis Institute for Medical Research Jewish General Hospital
      • Tampere, Finland
        • Recruiting
        • Tampere University Hospital
      • Brest, France
        • Recruiting
        • CHRU de Brest - Hôpital Morvan
      • Lille, France
        • Recruiting
        • CHRU de Lille
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
      • Marseille, France
        • Recruiting
        • Centre d'Essais Precoces en Cancerologie de Marseille
      • Paris, France
        • Recruiting
        • Hopital Bichat - Claude Bernard - AP-HP
      • Rennes, France
        • Recruiting
        • CHU Rennes - Hôpital Pontchaillou
      • Villejuif, France
        • Recruiting
        • Gustave Roussy
      • Budapest, Hungary
        • Recruiting
        • Orszagos Koranyi Pulmonologiai Intezet
      • Tatabanya, Hungary
        • Recruiting
        • Szent Borbála Kórház
      • Torokbalint, Hungary
        • Recruiting
        • Torokbalinti Tudogyogyintezet
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero-Universitaria delle Marche
      • Bologna, Italy
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
      • Meldola, Italy
        • Recruiting
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
      • Milano, Italy
        • Recruiting
        • Istituto Europeo di Oncologia
        • Principal Investigator:
          • Fillipo De Marinis
      • Padova, Italy
        • Recruiting
        • Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera
      • Torino, Italy
        • Recruiting
        • AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette
      • Rio Piedras, Puerto Rico
        • Recruiting
        • PanOncology Trials, LLC
      • Arkhangelsk, Russian Federation
        • Active, not recruiting
        • Arkhangelsk Clinical Oncological Dispensary
      • Otradnoye, Russian Federation
        • Active, not recruiting
        • JSC Group of companies Medsi
      • Saint Petersburg, Russian Federation
        • Active, not recruiting
        • Private Medical Institution Euromedservice
      • Saint Petersburg, Russian Federation
        • Active, not recruiting
        • Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)
      • Saransk, Russian Federation
        • Active, not recruiting
        • Ogarev Mordovia State University
      • St. Petersburg, Russian Federation
        • Active, not recruiting
        • JSC Current Medical Technologies
      • Volgograd, Russian Federation
        • Active, not recruiting
        • Volgograd regional clinical oncology dispensary
      • Singapore, Singapore
        • Recruiting
        • National Cancer Centre Singapore
      • Singapore, Singapore
        • Recruiting
        • Oncocare Cancer Centre
      • Singapore, Singapore
        • Recruiting
        • Tan Tock Seng Hospital
      • Badalona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic Barcelona
      • Barcelona, Spain
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
      • Valencia, Spain
        • Recruiting
        • Instituto Valenciano de Oncología
      • Taichung, Taiwan
        • Recruiting
        • Taichung Veterans General Hospital
      • Tainan, Taiwan
        • Recruiting
        • Chi-Mei Hospital - Liouying Branch
      • Taipei City, Taiwan
        • Recruiting
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan
        • Recruiting
        • Linkou Chang Gung Memorial Hospital (CGMHLK)
      • London, United Kingdom
        • Recruiting
        • University College London Hospital
      • London, United Kingdom
        • Active, not recruiting
        • Imperial College Healthcare NHS Trust
      • Manchester, United Kingdom
        • Recruiting
        • The Christie NHS foundation Trust
      • Surrey Quays, United Kingdom
        • Recruiting
        • Royal Marsden Hospital - Surrey
    • California
      • Loma Linda, California, United States, 92354
        • Active, not recruiting
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
      • Los Angeles, California, United States, 90033
        • Active, not recruiting
        • University of Southern California / Norris Comprehensive Cancer Center
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente - CA
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • UCSF - Helen Diller Family Comprehensive Cancer Center
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Providence Medical Foundation
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence St. Joseph Health
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente - Vallejo
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Hospital
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Florida Cancer Specialists - South
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists - North
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Florida Cancer Specialists
      • Tampa, Florida, United States, 33612
        • Active, not recruiting
        • Moffitt
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists
    • Maryland
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Maryland Oncology Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Dana Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • HealthPartners Cancer Research Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Research Institute
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University (OSU)
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • St. Francis Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon and HCA Research Institute
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • The Don & Sybil Harrington Cancer Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Cancer Institute
        • Contact:
          • BSN
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Major Inclusion Criteria:

  1. Men and women 18 years of age or older.
  2. 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); 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 E / Primary CNS tumors with MET alterations: subjects with primary CNS tumors who meet inclusion criteria of MET dysregulations defined as single or co-occurred MET fusion including PTPRZ1-MET (ZM) fusion, MET Exon 14 skipping mutations, or MET amplification; 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; neurological symptoms controlled on a stable/decreasing dose of steroids for at least 2 weeks before C1D1
    • 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.

Major Exclusion Criteria:

  1. Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
  2. Known actionable mutation/gene rearrangement of EGFR (except for NSCLC subjects in Cohort C and C-2), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
  3. Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination.
  4. 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 the trial.
  5. 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, or interfere with the absorption or metabolism of APL-101.
  6. 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 corrected by Fridericia formula (QTcF) at screening, or concurrent treatment with a medication that is a known risk for prolonging the QT interval. Chronic controlled atrial fibrillation is not excluded.
  7. 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 (HIV) positive subjects who are not clinically stable or controlled on their medication (asymptomatic subjects with CD4+ T-cell (CD4+) counts ≥ 350 cells/μL and have not had an opportunistic infection within the past 12 months prior to first dose of APL-101 would be eligible for study entry. If history is unclear, relevant test(s) at Screening will be required to confirm eligibility.
  8. 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 treatment or assessments.
  9. Unable to swallow orally administered medication whole.
  10. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption
  11. Women who are breastfeeding
  12. 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:

    1. Carcinoma of the skin without melanomatous features.
    2. Curatively treated cervical carcinoma in situ.
    3. 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 to recur within 3 years.
  13. Subjects 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 of study drug. Subjects may qualify if such medication(s) can be safely replaced with alternate medications with less risk of drug-drug interaction.
  14. Subjects with active COVID-19 infection.
  15. Symptomatic and/or neurologically unstable CNS metastases, or who require an increase in steroid dose to control CNS disease. Subjects who have been receiving a stable steroid dose for at least 2 weeks prior to C1D1 may be allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSCLC Exon 14 Skip Treatment Naive
Cohort A-1: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: NSCLC Exon 14 Skip Previously Treated
Cohort A-2: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: NSCLC Exon 14 MET Inhibitor Experienced
Cohort B: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: Basket of tumor types MET amplification except for primary CNS tumors
Cohort C: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: NSCLC MET amplification and EGFR wild-type
Cohort C-1: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: EGFR positive NSCLC MET amplification as an acquired resistance
Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: Basket of solid tumor with MET gene fusions except for primary CNS tumors
Cohort D: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: Primary CNS tumors with MET alterations
Cohort E: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib
Experimental: Basket of tumor types wild-type MET with over-expression of HGF and MET
Cohort F: APL-101 Oral Capsules
Subjects will receive APL-101 capsules BID for oral administration.
Other Names:
  • PLB-1001
  • CBI-3103
  • Bozitinib
  • CBT-101
  • Vebreltinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)
Time Frame: 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.
From time of informed consent signature through completion of treatment (1 cycle = 28 days) or progression

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR per investigator assessment based on RECIST v1.1.
Time Frame: Approximately 2 years
ORR per RECIST v1.1 or relevant evaluation criteria per tumor type.
Approximately 2 years
Median time to progression (TTP).
Time Frame: Approximately 2 years
TTP per RECIST v1.1 or relevant evaluation criteria per tumor type.
Approximately 2 years
Progression Free Survival (PFS) and overall survival (OS) at 6, 12, 18 and 24 months
Time Frame: Approximately 3 years
PFS and OS per RECIST v1.1 or relevant evaluation criteria per tumor type.
Approximately 3 years
Median duration of response (DOR) per IRC.
Time Frame: Approximately 2 years
DOR per RECIST v1.1 criteria, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Approximately 2 years
Median DOR per investigator assessment.
Time Frame: Approximately 2 years
DOR per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Approximately 2 years
Antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1, RANO criteria for CNS tumors, or other relevant criteria per tumor type Median time to progression (TTP).
Time Frame: Approximately 2 years
Benefit rate per RECIST v1.1, RANO criteria for CNS tumors, or relevant evaluation criteria per tumor type.
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Marietta Franco, Apollomics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2017

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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