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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 : September 25, 2018
Sponsor:
Collaborators:
Novotech (Australia) Pty Limited
CBT Pharmaceuticals, Inc.
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 schedule of CBT-501 in individuals with advanced or relapsed or recurrent solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Advanced Cancers Colorectal Cancer Gastric Cancer Hepatocellular Cancer Non Small Cell Lung Cancer Renal Cancer Head and Neck Squamous Cell Carcinoma CHL Urothelial Carcinoma Gastroesophageal Junction Adenocarcinoma Microsatellite Instability Mismatch Repair Deficiency Esophageal Cancer Cancer of Unknown Primary Site Carcinosarcoma Drug: CBT-501 Phase 1

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 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) or biologically effective dose (BED) is determined.

Cohort Extension will evaluate CBT-501 at 3 mg/kg and 10 mg/kg on Day 1 and Day 15 every 28 days and on Day 1 every 21 days in PD-1 approved labelled indications.

At the tentative MTD, BED or recommended Phase 2 dose (RP2D), at least four tumor types in the Dose and Disease Expansion will be assessed at a equivalent non-weight based dose to further evaluate toxicity and preliminary efficacy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 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, Cohort Extension and Dose and Disease Expansion 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 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Single-Arm
CBT-501
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). 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 and 1 dose of study drug administered on Day 1 of a 21-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.

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) ]
    Cmax

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

  5. Objective Response Rate (ORR) [ Time Frame: Approximately 24 months ]
    The treatment effect of CBT-501 will be assessed by RECIST v1.1 and by irRECIST to determine proportion of patients with complete response or partial response.

  6. Duration of Response (DOR) [ Time Frame: Approximately 24 months ]
    The treatment effect of CBT-501 will be assessed by RECIST v1.1 or by irRECIST to determine duration of response. Time from first documented complete response or partial response until subsequent documented disease progression or death.

  7. Time to Response (TTR) [ Time Frame: Approximately 24 months ]
    The treatment effect of CBT-501 will be assessed by RECIST v1.1 and by irRECIST to determine time to complete response and partial response.

  8. Disease Control Rate (DCR) [ Time Frame: Approximately 24 months ]
    The treatment effect of CBT-501 will be assessed by RECIST v1.1 and irRECIST to determine disease control rate. Proportion of patients with best overall response of complete response, partial response, or stable disease.

  9. Progression Free Survival [ Time Frame: Approximately 24 months ]
    The effect of CBT-501 will be assessed by RECIST v1.1 and per irRECIST to determine progression free survival as time from date of first dose to date of disease progression or death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 with at least 1% of PD-L1 expression by IHC per local laboratory.
  • Clear cell histology and carcinosarcomas with at least 1% of PD-L1 expression by IHC per local laboratory.
  • Esophageal carcinoma with advanced or metastatic disease either of adenocarcinoma or squamous histology with at least 1% of PD-L1 expression by IHC per local laboratory or tumor inflammation signature positive.

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.

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


Contacts
Contact: Shelly Nigam, MS (925) 272-4090 shelly.nigam@cbtpharma.com
Contact: Gavin Choy, PharmD (925) 272-4090 gavin.choy@cbtpharma.com

Locations
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         
The Tweed Hospital Recruiting
Tweed Heads, New South Wales, Australia, 2485
Contact: Sharon Clark    +61755067374    sharon.clark@ncahs.health.nsw.gov.au   
Principal Investigator: Ehtesham Abdi, MD         
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         
Peter MaCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Linda Mileshkin, MD    +61385595000    Linda.Mileshkin@petermac.org   
Principal Investigator: Linda M Mileshkin, MD         
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
CBT Pharmaceuticals, Inc.
Investigators
Study Chair: Tillman Pearce, MD Chief Medical Officer

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: September 25, 2018
Last Verified: September 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:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms
Colorectal Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Carcinoma, Transitional Cell
Head and Neck Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Liver Neoplasms
Carcinoma, Hepatocellular
Carcinosarcoma
Mixed Tumor, Mullerian
Microsatellite Instability
Brain Neoplasms
Neoplastic Syndromes, Hereditary
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases