Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

* 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

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

CBL0137

John Sarantopoulos, MD

Renuka Iyer, MD

Afshin Dowlati, MD

Manmeet Ahluwalia, MD

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.

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.

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

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.

Incuron

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm	NCT01905228	Solid Tumors Glioblastoma	CBL0137	15 Years -	Incuron
A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm	NCT01905228	Solid Tumors Glioblastoma	CBL0137	15 Years -	Incuron

Spots Global Cancer Trial Database for unresectable advance solid neoplasms