APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors

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 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

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