ABC-11
Research type
Research Study
Full title
A seamless multicentre phase Ib/II, single arm open-label dose escalation and expansion study to assess the safety and efficacy of selective HDAC6 inhibition with KA2507 in advanced biliary tract cancer previously treated with standard of care chemotherapy
IRAS ID
264933
Contact name
John Bridgewater
Contact email
Sponsor organisation
Karus Therapeutics Limited
Eudract number
2019-001459-38
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Although biliary tract cancers are relatively low-incidence malignant tumours in adults (0.7%) with approximately 1200 new cases registered in England and Wales per year, they are associated with a high mortality rate. Surgery offers the only chance of long-term cure, however, due to the aggressive nature of biliary tract cancer, most patients (>65%) are diagnosed in advanced stages when no surgery is feasible and when palliative chemotherapy is the only treatment available. The prognosis of patients diagnosed with advanced (metastatic or unresectable locally advanced disease) biliary tract cancer is poor.
The options for second line therapy in biliary tract cancer are modest and there is a need for new targetted treatments for this disease.
KA2507 is an inhibitor of the human protein Histone Deacetylase 6 (HDAC6) which has been identified as a target for anti-tumour effects.
This is a single arm trial evaluating the maximum safest tolerable dose of KA2507 in Part A of the study. Once a tolerable dose has been determined the second part of the study (Part B) will evaluate how effective KA2507 is at treating biliary tract cancer.
The aim of this trial is:
Part A) to determine the recommended Phase II dose (RP2D) of KA2507 for Part B.
Part B) to assess the effectiveness of the fixed recommended tolerable dose of KA2507.Patients will be recruited from up to 12 hospitals in the UK. Patients will receive KA2507 orally twice a day until progression or withdrawal. When no progressive disease occurs, follow up visits will continue for 12 months post-registration.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1538
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion