Brief Title
APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors
Official Title
A Phase 1 Multicenter, Dose Escalation, Cohort Extension and Dose and Disease Expansion Study of APL-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
Brief Summary
The purpose of this study is to determine the safety, tolerability, and recommended dose
schedule of APL-501 in individuals with advanced or relapsed or recurrent solid tumors.
Detailed Description
This is a Phase 1, multicenter, 3-part study with a Dose-Escalation Segment, Cohort Extension
and Dose and Disease Expansion cohorts of APL-501 injection, a humanized IgG4 monoclonal
antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and
other cells of the immune system. Select advanced solid tumor malignancies will receive
escalating doses of APL-501.
Dose escalation will occur in three subject cohorts until a protocol defined dose limited
toxicity (DLT) occurs, not due to disease progression or inter-current illness, and a
tentative maximum tolerated dose (MTD) or biologically effective dose (BED) is determined.
Cohort Extension will evaluate APL-501 at 3 mg/kg and 10 mg/kg on Day 1 and Day 15 every 28
days.
At the tentative MTD, BED or recommended Phase 2 dose (RP2D), at least two tumor types in the
Dose and Disease Expansion will be assessed at an equivalent non-weight based dose to further
evaluate toxicity and preliminary efficacy.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Determine the recommended Phase 2 dose and schedule
Condition
Solid Tumor
Intervention
APL-501
Study Arms / Comparison Groups
Single-Arm
Description: APL-501
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
March 27, 2017
Completion Date
June 2022
Primary Completion Date
December 2021
Eligibility Criteria
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 junction adenocarcinoma (GC), head and neck
(esophageal, hepatocellular (HCC), non-small cell lung cancer, mesothelioma, ovarian,
and renal cell carcinoma (RCC), either refractory or relapsed to standard therapy or
for which no effective standard therapy is available.
- No restriction to number of prior therapies for Dose Escalation Segment except for
gastric and renal cell carcinoma.
Cohort Extension:
- Histologically and/or cytological confirmed solid tumors with an approved labelled
indication for PD-1 inhibitors.
- Tumor biopsy at study entry and during therapy. Tumor sites used to satisfy this
criterion must not have received any prior radiation therapy. Sites for biopsy must be
distinct from target lesions used for efficacy assessment.
- Measurable disease according to RECIST v1.1.
Dose and Disease Expansion:
- MSI-H or dMMR per local laboratory and failed at least one prior line of standard of
care chemotherapy per local standards.
- Carcinoma of Unknown Primary
Major Exclusion Criteria:
- History of severe hypersensitivity to mAbs, excipients of the drug product or other
components
- Prior malignancy active within the previous 2 years except for locally curable cancers
that have been cured, such as basal or squamous cell skin cancer, superficial bladder
cancer or carcinoma in situ of the cervix or breast
- Any active autoimmune disease or a documented history of autoimmune disease, or
history of syndrome that required systemic steroids or immunosuppressive medications,
except for subjects with vitiligo or resolved childhood asthma/atopy
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or
any other antibody targeting T cell co-stimulation pathways) (except NSCLC)
- 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Scott Houston, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT03053466
Organization ID
APL-501-01
Responsible Party
Sponsor
Study Sponsor
Apollomics (Australia) Pty. Ltd.
Collaborators
Novotech (Australia) Pty Limited
Study Sponsor
Scott Houston, Study Director, Apollomics (Australia) Pty. Ltd.
Verification Date
June 2021