A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

NCT01905228 | Completed Phase 1

• 1 other identifier: I137-101
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.

Conditions

Solid Tumors; Glioblastoma

Keywords

Metastatic Advance Solid Neoplasms; Unresectable Advance Solid Neoplasms

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

  MTD is defined as dose level at which ≥6 participants have been treated and which is associated with a first-cycle DLT in ≤17% of the participants. Selection of RP2D from within the tolerated dose range will be based on evaluation of short- and long-term safety information together with findings relating to compliance, pharmacokinetics, pharmacodynamics and antitumor activity.

  At the end of Cycle 1 (each cycle is 28 days)

Study Arms (1)

CBL0137

EXPERIMENTAL

* Dose Level 9: 150 mg/m2, IV * Dose Level 10: 180 mg/m2, IV * Dose Level 11: 240 mg/m2, IV * Dose Level 12: 320 mg/m2, IV * Dose Level 13: 400 mg/m2, IV * Dose Level 14: 540 mg/m2, IV * Dose Level 15: 700 mg/m2, IV * Dose Level 16: 920 mg/m2, IV * Dose Level 17: 1200 mg/m2, IV * Dose Level 18: 1600 mg/m2, IV * Dose Level 19: 2100 mg/m2, IV * Dose Level 20: 2700 mg/m2, IV

Drug: CBL0137

Interventions

CBL0137 DRUG

All doses are administered intravenously on Days 1, 8 and 15 of every 28 day cycle. Number of Cycles: 2 or until progression or unacceptable toxicity develops

Also known as: Curaxin

CBL0137

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histological or cytological evidence of a solid neoplasm
• Patients enrolled in the expansion cohort must have at least one measureable lesion as defined by the RECIST 1.1 criteria for patients with systemic tumors or the RANO criteria for patients with gliomas;
• Patients with a systemic tumor must:
• have metastatic or unresectable advanced solid tumors that have recurred or progressed following standard therapy or
• no longer be candidates for standard therapy or
• have tumors for which there is no standard therapy
• Patients with a glioma must:
• have Grade III (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma) disease, Grade IV (glioblastoma) disease, or diffuse intrinsic pontine glioma (DIPG) and;
• have received prior therapy including radiation and drug therapy and;
• have documented recurrent disease as defined in the RANO criteria;
• Patients must be ambulatory and have an ECOG Performance Score of 0 or 1;
• Patients or their legal representative must be able to provide written informed consent;
• Patients must have adequate bone marrow reserve as evidenced by:
• White Blood Cell Count (WBC) \> 3,000/µL
• Absolute Neutrophil Count (ANC) \> 1,500/µL

You may not qualify if:

• Patients with active infection or with a fever \> 38.50 C within 3 days of the first scheduled day of dosing;
• Patients with symptomatic CNS metastases who have not undergone surgery and/or radiotherapy and/or who are not neurologically stable;
• Patients with known hypersensitivity to any of the components of CBL0137;
• Patients who are receiving concurrent anticancer therapy;
• Patients receiving enzyme-inducing antiepileptic agents within 14 days prior to the start of study therapy;
• Males with mean QTcF values of \> 450 msec and females with QTcF values of \> 470 msec following 3 ECGs conducted 5 minutes apart from each other; patients who are known to have congenital prolonged QT syndromes; or patients who are on medications known to cause prolonged QT intervals on ECG;

Sponsors & Collaborators

• Incuron: lead

Study Sites (4)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University Hospital of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

CTRC at The University of Texas Healh Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

CBLC137

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• John Sarantopoulos, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Renuka Iyer, MD

  Roswell Park Cancer Institue

  PRINCIPAL INVESTIGATOR

• Afshin Dowlati, MD

  University Hospital of Cleveland

  PRINCIPAL INVESTIGATOR

• Manmeet Ahluwalia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (4)