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

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ClinicalTrials.gov Identifier: NCT03053466
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 8, 2018
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
CBT Pharmaceuticals (Australia) Pty Ltd

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.

Condition or disease Intervention/treatment Phase
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 Drug: CBT-501 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Multicenter, Dose Escalation Study of CBT-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Single-Arm
Drug: CBT-501
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 Name: GB226

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) ]

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

  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053466

Contact: Purvi Patel, MS (925) 272-4090 purvi.patel@cbtpharma.com
Contact: Gavin Choy, PharmD, MBA (925) 272-4090 gavin.choy@cbtpharma.com

Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Jacquie Harvey    +61 2 8514 0194    Jacquie.Harvey@lh.org.au   
Contact: Catriona McNeil, MBBS    +61 2 8514 0144    catriona.mcneil@lh.org.au   
Principal Investigator: Catriona McNeil, MBBS         
Australia, Victoria
Cabrini Education and Research Precinct Recruiting
Malvern, Victoria, Australia, 3144
Contact: Nina Box    +61 (0)3 9508 3421    n.box@cabrini.co.au   
Contact: Kate Hurford    +61 (0) 3 9508 3411    KHurford@cabrini.com.au   
Principal Investigator: Gary Richardson, MBBS         
Nucleus Network Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Stefanie Hartley    +61 3 9076 9020    s.hartley@nucleusnetwork.com.au   
Principal Investigator: Mark Voskoboynik, MBBS         
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Zelda Herbst    +61 (0) 8 6382 5113    zherbst@linear.org.au   
Principal Investigator: Michael Millward, MBBS         
Sponsors and Collaborators
CBT Pharmaceuticals (Australia) Pty Ltd
Novotech (Australia) Pty Limited
Study Director: Gavin Choy, PharmD, MBA EVP and Chief Operating Officer, CBT Pharmaceuticals, Inc.

Additional Information:
Responsible Party: CBT Pharmaceuticals (Australia) Pty Ltd
ClinicalTrials.gov Identifier: NCT03053466     History of Changes
Other Study ID Numbers: CBT-501-01
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CBT Pharmaceuticals (Australia) Pty Ltd:
Advanced Solid Tumor
Relapsed Solid Tumor
Recurrent Solid Tumor

Additional relevant MeSH terms:
Colorectal Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Endometrial Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Nasopharyngeal Neoplasms
Liver Neoplasms
Carcinoma, Non-Small-Cell Lung
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Mesothelial
Uterine Neoplasms