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APL-501

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

APL-501 · 1 trial · 4 indications

Phase 1 1
NCT03053466APL-501 Study for Select Advanced or Relapsed/Recurrent Solid TumorsSolid Tumor
COMPLETED30 Analytics
PHASE1COMPLETED
APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors
Solid TumorUnlock trial analytics

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 to 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 (matched to "Solid Tumor")

Frequently asked questions about APL-501

What is APL-501 used for?

APL-501 is an investigational small molecule being developed for the treatment of solid tumors. It is being studied in patients with advanced or relapsed/recurrent solid tumors, including those with microsatellite instability, mismatch repair deficiency, and cancer of unknown primary site. The drug is currently in Phase 1 clinical development.

Who makes APL-501?

APL-501 is being developed by Apollomics Inc., a biopharmaceutical company. Apollomics is publicly traded under the ticker symbol APLM. The company is conducting clinical trials to evaluate the safety and efficacy of APL-501 in patients with solid tumors.

What phase is APL-501 in?

APL-501 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of APL-501 has been completed, and the drug remains in early-stage clinical development for the treatment of solid tumors.

What clinical trials is APL-501 in?

APL-501 has been studied in a Phase 1 clinical trial with the identifier NCT03053466. This trial, titled 'APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors,' enrolled 30 participants in Australia. The study has been completed and was an uncontrolled, non-randomized trial.

How does APL-501 work?

APL-501 is a small molecule therapeutic. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential to treat solid tumors, including those with microsatellite instability and mismatch repair deficiency.