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

Solid Tumor Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cancer of Unknown Primary Site
• Microsatellite Instability
• Mismatch Repair Deficiency
• Neoplasms
• Neoplasms, Unknown Primary
• Solid Tumor

• NCT number: NCT03053466
• Study type: Interventional
• Source: Apollomics (Australia) Pty. Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2017
• Completion date: February 25, 2022