Clinical Trial Details

NCT ID: NCT03175224
Date Last Changed: September 25, 2017

Overview

Research Study Summary

A clinical research study of CBT-101 Oral Capsules

Research Study Title

Phase 1 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of CBT-101 in Subjects With Advanced Solid Tumors and c-Met Dysregulation

Purpose

The purpose of this study is to determine the safety, tolerability, and recommended dose of CBT-101 in individuals with advanced solid tumors and c-MET dysregulation.

To Learn more

Recruitment Details

Phase
1
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
CBT Pharmaceuticals, Inc.
Duration
9 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Major Inclusion Criteria:

  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.

  • Dose Escalation Segment: histologically and / or cytological confirmed locally advanced, recurrent or relapsed, or metastatic incurable solid malignancy with no limit on the number of prior lines of standard therapy.

  • Dose and Disease Expansion Cohorts: histologically confirmed renal cell carcinoma, gastric carcinoma (including gastro-esophageal junction adenocarcinoma), and a biomarker driven cohort of tumors with evidence of c-MET dysregulation (amplification, mutation)

  • Renal Cell Carcinoma: documented histological or cytological diagnosis of renal cell cancer with a clearcell or papillary component; progression following at least two prior lines of standard therapy including a checkpoint inhibitor and an anti-VEGFR inhibitor; archival tissue or fresh tumor biopsy

  • Gastric Carcinoma (including Gastro-Esophageal Junction Adenocarcinoma): progression following at least one prior line of standard therapy that contained a fluoropyrimidine and/or platinum and/or taxane agent; prior adjuvant or neoadjuvant therapy is counted as one regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy; HER2 negative subjects (defined by HER2 ≤ 2+ by IHC) by medical history; archival tissue or fresh tumor biopsy

  • Abnormal c-MET dysregulation, defined as the following from archival historical results of molecular pre-screening evaluations.

  • Dose Escalation Segment

  • c-MET overexpression, ≥ 50% tumor cells with immunohistochemistry Grade 3+

  • or c-MET amplification; FISH c-MET to chromosome 7 (CEP 7) ratio ≥ 2.2; NGS copy number variation ≥ 4

  • or mutation, including any deletions and any met fusions

  • Dose and Disease Expansion Cohorts

  • c-MET amplification; FISH c-MET to chromosome 7 (CEP 7) ratio ≥ 2.2; NGS copy number variation ≥ 4

  • or mutation, including any deletions and any met fusions

  • Measurable disease according to RECIST v1.1

  • No chemotherapy treatments within at least 3 weeks prior to first dose of study treatment. For all prior anticancer treatment, including radiotherapy or targeted agents or hormonal therapy, a duration of more than 5 half-lives of the targeted/hormonal agents used must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria.

  • Adequate cardiac function (≤ NYHA Class II) or normal cardiac function with left ventricular ejection fraction (LVEF) ≥ 50% at screening.

Major Exclusion Criteria:

  • Hypersensitivity to CBT-101, excipients of the drug product, or other components of the study treatment regimen.

  • History of receiving treatment with any c-MET signaling pathway inhibitor (marketed or investigational agents)

  • History of, or at risk for, cardiac disease (e.g., long QT syndrome [ > 450 msec] or concurrent treatment with any medication that prolongs QT interval).

  • Symptomatic primary tumors or metastasis of brain and/or central nervous system, uncontrolled with antiepileptic and requiring high doses of steroids.

  • Unable to swallow orally administered medication whole.

  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).

  • Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with complications from prior radiation therapy are not eligible and AEs must return to baseline or ≤ Grade 1.

Site Locations (1)

Country State City Zip Facility and Contact
United States California Los Angeles 90033 University of Southern California / Norris Comprehensive Cancer Center
Jubilee Acap
323-865-0593
jubilee.acap@med.usc.edu

Anthony El-Khoueiry, MD
Principal Investigator

Contact

Purvi Patel, MS
(925) 272-4090
E-mail:

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