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A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer

2019-12-10 01:20:59 | BioPortfolio

Summary

To evaluate the safety, tolerability and preliminary evidence for efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.

The specific aims of each part of the study are:

Part A : Phase Ib primary objective - to determine the recommended phase II dose (RP2D) of KA2507 for part B and evaluate its tolerability profile in advanced BTC.

Part B: Phase II primary objective - to assess the efficacy of KA2507 in patients with advanced BTC at the dose defined in part A.

Description

To evaluate the safety, tolerability and preliminary evidence for efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.

The specific aims of each part of the study are:

Part A : Phase Ib primary objective - to determine the recommended phase II dose (RP2D) of KA2507 for part B and evaluate its tolerability profile in advanced BTC.

Part B: Phase II primary objective - to assess the efficacy of KA2507 in patients with advanced BTC at the dose defined in part A.

ABC-11 is an open-label, multi-centre study of HDAC6 inhibition using KA2507 in patients with advanced biliary tract cancer previously treated with standard of care chemotherapy.

Part A design (phase Ib safety - dose finding)

This is a phase Ib dose finding study to determine the recommended Phase II dose (RP2D) for Part B.

Dose escalation of KA2507 in Part A will be based on a combination of treatment-related dose limiting toxicities (DLTs) at the end of cycle 1 and (plasma) KA2507 pharmacokinetics. This dose finding study will be conducted using the modified continual reassessment method (CRM)1-3, a model-based design that informs how the dosage of KA2507 should be adapted for the next patient cohort based on past trial data. The RP2D will be defined as the highest dose that has an estimated probability of a DLT closest to a target toxicity level of 30%. Patients will be dosed in cohorts of 2, with a maximum available sample size of 8 evaluable patients.

Part B design (phase II efficacy)

This is a single-arm single-stage phase II study designed using A'Hern's methodology.

Patients for part B are comprised of two groups: 1) the patients from Part A treated at the dose to be tested in Part B; and 2) an additional expansion cohort of patients registered to part B. A fixed daily dose of KA2507 will be administered to all patients based on the RP2D determined in Part A (anticipated to be one of either 800 mg bid, 1200 mg bid or 1600 mg daily bid).

Study Design

Conditions

Biliary Tract Cancer

Intervention

KA2507

Status

Not yet recruiting

Source

Karus Therapeutics Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-10T01:20:59-0500

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Medical and Biotech [MESH] Definitions

Tumors or cancer in the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.

Abnormal passage in any organ of the biliary tract or between biliary organs and other organs.

Diseases in any part of the BILIARY TRACT including the BILE DUCTS and the GALLBLADDER.

Chronic inflammatory disease of the BILIARY TRACT. It is characterized by fibrosis and hardening of the intrahepatic and extrahepatic biliary ductal systems leading to bile duct strictures, CHOLESTASIS, and eventual BILIARY CIRRHOSIS.

Any surgical procedure performed on the biliary tract.

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