Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Dose level -1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Patient will be enrolled at 3 dose levels of CBL 0137, dose level -1 (320 mg/m²), dose level 1 (400 mg/m²), dose level 2 (540 mg/m²)

CBL0137

Anthony Olszanski, MD

Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

The primary objectives will be Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

MEL-212: A Phase I Proof-of-Concept Study of CBL0137 (Curaxin) Combined With Ipilimumab and Nivolumab Therapy in Locally Advanced or Metastatic Melanoma

The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)

Incuron

Fox Chase Cancer Center

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

* 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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma	NCT05498792	Locally Advance...	CBL0137 Ipilimumab Nivolumab	18 Years -	Fox Chase Cancer Center
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
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma	NCT05498792	Locally Advance...	CBL0137 Ipilimumab Nivolumab	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for cbl0137

Every month we try and update this database with for cbl0137 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cbl0137

Every month we try and update this database with for cbl0137 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cbl0137 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.