cropped color_logo_with_background.png

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 15 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - Platelet count (PLT) > 75,000/µL.
  • - Hemoglobin (HGB) > 8.0 gm/dL (patients may be transfused to achieve this HGB level); - Patients must have adequate hepatic function as evidenced by: - Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X the ULN for patients with known hepatic metastases) - Serum bilirubin < 1.5 x the ULN for the reference lab;

    Exclusion Criteria:

    - 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; Please speak with the PI for the complete Inclusion/Exclusion listing.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01905228
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Incuron
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John Sarantopoulos, MDRenuka Iyer, MDAfshin Dowlati, MDManmeet Ahluwalia, MD
Principal Investigator Affiliation The University of Texas Health Science Center at San AntonioRoswell Park Cancer InstitueUniversity Hospital of ClevelandThe Cleveland Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumors, Glioblastoma
Additional Details

The primary objective of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a study of CBL0137 with a standard "3+3" design. Escalation will proceed to the MTD based on DLT in the 1st cycle in 1 of 6 participants in a cohort.

Arms & Interventions

Arms

Experimental: CBL0137

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

Interventions

Drug: - CBL0137

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

University Hospital of Cleveland, Cleveland, Ohio

Status

Address

University Hospital of Cleveland

Cleveland, Ohio, 44106

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

San Antonio, Texas

Status

Address

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

San Antonio, Texas, 78229