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

NCT03053466 | Completed Phase 1

• 1 other identifier: APL-501-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Solid Tumor; Microsatellite Instability; Mismatch Repair Deficiency; Cancer of Unknown Primary Site

Keywords

Advanced Solid Tumor; Relapsed Solid Tumor; Recurrent Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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

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

  From the time of informed consent from signature until Day 28 after Cycle 1; Dose Escalation - Approximately 9 months

Secondary Outcomes (9)

• 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)

• Time to reach Cmax

  Up to 4 months (1 cycle = 28 days)

• Objective Response Rate (ORR)

  Approximately 24 months

Study Arms (1)

Single-Arm

EXPERIMENTAL

APL-501

Drug: APL-501

Interventions

APL-501 DRUG

Subjects 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.

Also known as: GB226, genolimzumab

Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apollomics (Australia) Pty. Ltd.: lead
• Novotech (Australia) Pty Limited: collaborator
• Apollomics Inc. (formerly CBT Pharmaceuticals, Inc.): collaborator

Study Sites (5)

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Cabrini Health Limited

Malvern, Victoria, 3144, Australia

Location

Peter MaCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Links

• Company website for Apollomics Inc.

MeSH Terms

Conditions

Microsatellite Instability; Turcot syndrome; Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Neoplastic Processes; Neoplasms

Study Officials

• Marietta Franco

  Apollomics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 15, 2017
• Study Start: March 27, 2017
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)