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

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.

Tracking Information
First Received DateJanuary 30, 2017
Last Changed DateMay 31, 2017
Start DateMarch 27, 2017
Anticipated Primary Completion DateFebruary 2018
Primary Outcome Measures

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]

Secondary Outcome Measures

Determine the recommended Phase 2 dose and schedule [Time Frame: An average of 1 year]

Area under the plasma concentration versus time curve (AUC) [Time Frame: Up to 4 months (1 cycle = 28 days)]

Maximum plasma concentration [Time Frame: Up to 4 months (1 cycle = 28 days)]

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

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

Duration of Response [Time Frame: Approximately 24 months]

Time to Response [Time Frame: Approximately 12 months]

Disease Control Rate [Time Frame: Approximately 24 months]

Progression Free Survival [Time Frame: Approximately 24 months]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • 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
Intervention
  • Drug: Genolimzumab injection
Study Arms / Comparison Groups1 / 0
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment50
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Purvi Patel, MS
Email: purvi.patel@cbtpharma.com
Phone: (925) 272-4090
Eligibility 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

Administrative Information
NCTIDNCT03053466
Responsible Party,
SponsorCBT Pharmaceuticals, Inc.
Verification DateMay 2017
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