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.
|First Received Date||January 30, 2017|
|Last Changed Date||February 7, 2018|
|Start Date||March 27, 2017|
|Anticipated Primary Completion Date||February 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]
|Study Arms / Comparison Groups||1 / 0|
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.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
Purvi Patel, MS
Phone: (925) 272-4090
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
|Sponsor||CBT Pharmaceuticals (Australia) Pty Ltd|
|Verification Date||February 2018|