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History of Changes for Study: NCT03053466
CBT-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors
Latest version (submitted May 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 12, 2017 None (earliest Version on record)
2 February 22, 2017 Contacts/Locations and Study Status
3 March 14, 2017 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 March 30, 2017 Study Status
5 May 31, 2017 Contacts/Locations and Study Status
6 August 30, 2017 Study Status and Contacts/Locations
7 September 25, 2017 Arms and Interventions and Study Status
8 February 7, 2018 Sponsor/Collaborators, Study Status and Study Identification
9 September 9, 2018 Contacts/Locations, Outcome Measures, Study Status, Study Description, Eligibility, Arms and Interventions, Study Design, Conditions, Sponsor/Collaborators and Study Identification
10 September 21, 2018 Contacts/Locations and Study Status
11 December 13, 2018 Contacts/Locations and Study Status
12 March 20, 2019 Recruitment Status, Study Identification, Contacts/Locations, Arms and Interventions, Sponsor/Collaborators, Study Status, Study Description, References and Outcome Measures
13 June 4, 2019 Contacts/Locations and Study Status
14 September 8, 2020 Recruitment Status, Study Status, Contacts/Locations, Eligibility, Arms and Interventions, Study Design, Conditions and Study Description
15 June 7, 2021 Recruitment Status, Contacts/Locations, Study Status, Study Design and Arms and Interventions
16 May 5, 2022 Recruitment Status, Study Status and Contacts/Locations
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Study NCT03053466
Submitted Date:  February 12, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: CBT-501-01
Brief Title: CBT-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors
Official Title: A Phase 1 Multicenter, Dose Escalation Study of CBT-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Not yet recruiting
Study Start: February 2017
Primary Completion: February 2018 [Anticipated]
Study Completion: March 2019 [Anticipated]
First Submitted: January 30, 2017
First Submitted that
Met QC Criteria:
February 12, 2017
First Posted: February 15, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
February 12, 2017
Last Update Posted: February 15, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Apollomics Inc.
Responsible Party: Sponsor
Collaborators: Novotech (Australia) Pty Limited
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to determine the safety, tolerability, and recommended dose of CBT-501 in individuals with advanced or relapsed or recurrent solid tumors.
Detailed Description:

This is a Phase 1, multicenter, 2-part study with a Dose-Escalation Segment and Dose and Disease Expansion Cohort of CBT-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 CBT-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) is determined.

At the tentative MTD or recommended Phase 2 dose (RP2D), at least two tumor types will be assessed to further evaluate toxicity and preliminary efficacy.

Open or close this module Conditions
Conditions: Solid Tumor
Advanced Cancer
ColoRectal Cancer
Endometrial Cancer
Gastric Cancer
Hepatocellular Cancer
Nonsmall Cell Lung Cancer
Mesothelioma
Ovarian Cancer
Renal Cancer
Nasopharyngeal Cancer
Esophageal Cancer
Gastroesophageal Junction Adenocarcinoma
Keywords: Advanced Solid Tumor
Relapsed Solid Tumor
Recurrent Solid Tumor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Single-Arm
Genolimzumab injection
Drug: Genolimzumab injection
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). Each treatment cycle is comprised of 2 doses of study drug administered by IV infusion on Days 1, 15 on a 28-day cycle.
Other Names:
  • CBT-501
  • GB226
Open or close this module Outcome Measures
Primary Outcome Measures:
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
[ Time Frame: 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 Outcome Measures:
1. Determine the recommended Phase 2 dose and schedule
[ Time Frame: An average of 1 year ]

adverse events, serious adverse events, dose limiting toxicities
2. Area under the plasma concentration versus time curve (AUC)
[ Time Frame: Up to 4 months (1 cycle = 28 days) ]

AUC, 0-infinity
3. Maximum plasma concentration
[ Time Frame: Up to 4 months (1 cycle = 28 days) ]

Cmax
4. Time to reach Cmax
[ Time Frame: Up to 4 months (1 cycle = 28 days) ]

Tmax
5. Overall Objective Response Rate
[ Time Frame: Approximately 12 months ]

Antitumor activity per RECIST v1.1 and by irRECIST
6. Duration of Response
[ Time Frame: Approximately 24 months ]

Antitumor activity per RECIST v1.1
7. Time to Response
[ Time Frame: Approximately 12 months ]

Antitumor activity per irRECIST
8. Disease Control Rate
[ Time Frame: Approximately 24 months ]

Antitumor activity per RECIST v1.1
9. Progression Free Survival
[ Time Frame: Approximately 24 months ]

Antitumor activity per RECIST v1.1 and per irRECIST, deaths from any cause
Other Outcome Measures:
1. Correlation of tumor-infiltrating lymphocyte counts at baseline and post administration of CBT-501
[ Time Frame: Approximately 24 months ]

2. Correlation of PD-1 and PD-L1 expression at baseline to clinical response
[ Time Frame: Approximately 24 months ]

3. PD-1 receptor occupancy of CBT-501
[ Time Frame: Up to 6 months ]

4. Degree of immunogenicity of CBT-501
[ Time Frame: Approximately 24 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Major Inclusion Criteria:

  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent
  • Histologically and / or cytological confirmed solid tumors: colorectal, endometrial, gastric including, gastroesophageal junction adenocarcinoma (GC), head and neck (esophageal, nasopharyngeal), 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
  • Receive no more than three systemic prior therapies for Dose and Disease Expansion Cohorts
  • Tumor biopsy at study entry and during therapy
  • Measurable disease according to RECIST v1.1

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)
  • Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids
Open or close this module Contacts/Locations
Central Contact Person: Purvi Patel, MS
Telephone: (925) 272-4090
Email: purvi.patel@cbtpharma.com
Central Contact Backup: Gavin Choy, PharmD, MBA
Telephone: (925) 272-4090
Email: gavin.choy@cbtpharma.com
Study Officials: Gavin Choy, PharmD, MBA
Study Director
EVP and Chief Operating Officer, CBT Pharmaceuticals, Inc.
Locations: Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Contact:Contact: Stefanie Hartley +61 3 9076 9020 s.hartley@nucleusnetwork.com.au
Contact:Principal Investigator: Mark Voskoboynik, MBBS
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Contact:Contact: Zelda Herbst +61 (0) 8 6382 5113 zherbst@linear.org.au
Contact:Principal Investigator: Michael Millward, MBBS
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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