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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03175224




Registration number
NCT03175224
Ethics application status
Date submitted
1/06/2017
Date registered
5/06/2017
Date last updated
25/03/2021

Titles & IDs
Public title
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Scientific title
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
Secondary ID [1] 0 0
APL-101-01 (CBT-101-01)
Universal Trial Number (UTN)
Trial acronym
SPARTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Advanced Cancer 0 0
Renal Cancer 0 0
Gastric Cancer 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
NSCLC 0 0
Lung Cancer 0 0
Brain Tumor 0 0
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - APL-101 Oral Capsules

Experimental: Single-Arm - APL-101 Oral Capsules


Treatment: Drugs: APL-101 Oral Capsules
Phase 1 Subjects will be assigned to a dose level of APL-101 in the order of study entry. Treatment includes 28-day cycles at four planned dose levels (100mg, 200mg, 300mg and 400mg). Each treatment cycle is administered by daily oral capsules taken every 12 hours.
Phase 2 Subjects will be given 400mg daily dose (200mg BID) of APL-101 capsules.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimate the maximum tolerated dose (MTD) and the incidence of DLTs - Adverse events, serious adverse events, and dose limiting toxicities
Timepoint [1] 0 0
From the time of informed consent signature through Cycle 1 (28 days) completion
Primary outcome [2] 0 0
Determine response rate in Phase 2 - Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.
Timepoint [2] 0 0
From time of informed consent signature through completion of Cycle 2 (1 cycle = 28 days)
Secondary outcome [1] 0 0
Incidence of SAE and AEs - Adverse events, serious adverse events, and dose limiting toxicities according to the National Cancer Institute (NCI) Terminology Criteria for Adverse Events (CTCAE v4.03)
Timepoint [1] 0 0
Approximately 1 year
Secondary outcome [2] 0 0
Area under the plasma concentration versus time curve (AUC) - AUC, 0 - infinity
Timepoint [2] 0 0
Up to 2 months (1 cycle = 28 days)
Secondary outcome [3] 0 0
Maximum plasma concentration - Cmax
Timepoint [3] 0 0
Up to 2 months (1 cycle = 28 days)
Secondary outcome [4] 0 0
Time to reach Cmax - Tmax
Timepoint [4] 0 0
Up to 2 months (1 cycle = 28 days)
Secondary outcome [5] 0 0
Duration of Response - Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [6] 0 0
Progression Free Survival - Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.
Timepoint [6] 0 0
Approximately 24 months
Secondary outcome [7] 0 0
Overall Survival - Anti-tumor activity per RECIST v1.1 or relevant evaluation criteria per tumor type.
Timepoint [7] 0 0
Approximately 24 months

Eligibility
Key inclusion criteria
Major

- Able to understand and comply with study procedures, understand the risks involved,
and provide written informed consent.

- For Phase 1, histologically and / or cytological confirmed unresectable or metastatic
solid malignancy, refractory to standard therapies with no more than three prior lines
of therapy.

- For Phase 2, five cohorts will be enrolled: Cohort A-1: NSCLC EXON 14 skip mutation
(c-Met naïve) for first line treatment, Cohort A-2: NSCLC EXON 14 skip mutation (c-Met
naïve) pretreated subjects with no more than 3 lines of prior therapy, Cohort B: NSCLC
EXON 14 skip mutation (c-Met experienced; radiographic progression on prior c-Met
inhibitor), Cohort C: basket of tumor types with c-Met high level amplification (NSCLC
EXON 14 skip mutation excluded), Cohort D: basket of tumor type with c-Met fusions.

- Local/archival result (tissue and/or plasma) of a positive c-Met dysregulation is
required

- Measurable disease according to RECIST v1.1. (or relevant criteria per tumor type).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- For all prior anticancer treatment, including radiotherapy, chemotherapy or targeted
agents or hormonal therapy, a duration of more than 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.

- No planned major surgery within 4 weeks of first dose of APL-101

Major
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hypersensitivity to APL-101, excipients of the drug product, or other components of
the study treatment regimen.

- Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK,
KRAS, and BRAF.

- 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 (> 450 msec based on the average of 3 measurements), or concurrent treatment
with a medication that is a known risk for prolonging the QT interval.

- Unable to swallow orally administered medication whole.

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active
inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption
syndrome).

- Women who are breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Border Medical Oncology - Albury
Recruitment hospital [3] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [5] 0 0
Calvary Central Districts Hospita - North Adelaide
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Albury
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment postcode(s) [5] 0 0
- North Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Delaware
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United States of America
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Florida
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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West Virginia
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Wisconsin
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Canada
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Quebec
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Canada
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Edmonton
Country [22] 0 0
Canada
State/province [22] 0 0
Montréal
Country [23] 0 0
Canada
State/province [23] 0 0
Toronto
Country [24] 0 0
Canada
State/province [24] 0 0
Winnipeg
Country [25] 0 0
Finland
State/province [25] 0 0
Helsinki
Country [26] 0 0
Finland
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Tampere
Country [27] 0 0
France
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Brest
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France
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Lille
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France
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Lyon
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France
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Paris
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France
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Rennes
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France
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Villejuif
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Italy
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Meldola
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Italy
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Milan
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Puerto Rico
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Rio Piedras
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Russian Federation
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Arkhangelsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saransk
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Russian Federation
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St. Petersburg
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Russian Federation
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Volgograd
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Singapore
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Singapore
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Spain
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Badalona
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Barcelona
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Madrid
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Spain
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Majadahonda
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Spain
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Oviedo
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Spain
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San Sebastián
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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New Taipei City
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Taiwan
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Tainan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Ukraine
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Dnipropetrovs'k
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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United Kingdom
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Manchester
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United Kingdom
State/province [59] 0 0
Surrey Quays

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Apollomics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary Phase 1 purpose of this study is to assess overall safety and tolerability and
recommended Phase 2 dose (RP2D) of APL-101.

The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals
with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation
Advanced Solid Tumors
Trial website
https://clinicaltrials.gov/show/NCT03175224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynn Manlapaz-Espiritu
Address 0 0
Sr Director, Clinical Operations
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lynn Manlapaz-Espiritu
Address 0 0
Country 0 0
Phone 0 0
16502094055
Fax 0 0
Email 0 0
infomed@apollomicsinc.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03175224