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APL-501

Phase 1

Solid Tumor | Small molecule | Oncology |Apollomics Inc.|Last Updated: May 9, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03053466APL-501 Study for Select Advanced or Relapsed/Recurrent Solid TumorsPHASE1 COMPLETED 30 — — Mar 27, 2017Feb 25, 2022May 9, 20225 Australia
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Study Endpoints
Primary Endpoints
Number of participants with treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients with advance solid tumors
From the time of informed consent from signature until Day 28 after Cycle 1; Dose Escalation - Approximately 9 months

Adverse events, serious adverse events, dose limiting toxicities according to the National Cancer Institute (NCI) Terminology Criteria for Adverse Events (CTCAE v4.03)

Secondary Endpoints
Determine the recommended Phase 2 dose and schedule
An average of 1 year
Area under the plasma concentration versus time curve (AUC)
Up to 4 months (1 cycle = 28 days)
Maximum plasma concentration
Up to 4 months (1 cycle = 28 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single-ArmEXPERIMENTALAPL-501
Interventions
NameTypeDescription
APL-501DRUGSubjects will be assigned to a dose level in the order of study entry. Treatment includes a minimum of four 28-day cycles at three planned dose levels (1, 3, and 10 mg/kg). In the Dose Escalation Segment, each treatment cycle is comprised of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In the Cohort Extension, the treatment cycle will consist of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In Dose and Disease Expansion, the treatment cycle will consist of 2 doses of study drug (non-weight based dosing of 400 mg) administered on Days 1 and 15 of a 28-day cycle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Major Inclusion Criteria: • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent. Dose Escalation: * Histologically and / or cytological confirmed solid tumors: colorectal, endometrial, gastric including, gastroesophageal junctio...

Countries:Australia
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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