Phase 1/2 dose-escalation study of CTX-SPL9111 in cancer patients
Research type
Research Study
Full title
A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CTX-SPL9111 (a cabazitaxel (CTX)-dendrimer conjugate) in patients with advanced solid tumours
IRAS ID
234167
Contact name
James Spicer
Contact email
Sponsor organisation
Starpharma Pty Ltd
Eudract number
2017-003424-76
Duration of Study in the UK
1 years, 5 months, 20 days
Research summary
This is a phase 1/2 dose-escalation study to establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of CTX-SPL9111 (a cabazitaxel (CTX)-dendrimer conjugate) given intravenously (IV) in patients with advanced solid tumours. CTX-SPL9111 is designed to reduce or lessen the toxicity associated with and potentially improve the efficacy of cytotoxic compounds for the treatment of locally and advanced metastatic solid cancers including prostate cancer.
This is an open-label sequential dose-escalation phase 1/2 study in 2 parts: (i) dose escalation (Phase 1) and (ii) dose expansion (Phase 2). The dose escalation phase includes an accelerated escalation phase to reduce patients’ exposure to ineffective doses and increase speed of completion. Once the maximum tolerated dose (MTD) and recommended phase two dose(RP2D) has been defined (Phase 1), up to an additional 20 patients will receive CTX-SPL9111 at the RP2D during the dose expansion phase (Phase 2).Enrolment may be restricted to specific tumour types in Phase 2, such as those known to be responsive to cabazitaxel or that are found to respond to CTX-SPL9111 during Phase 1 of the study.
Each dose of CTX-SPL9111 will be administered IV over 1 hour using an infusion pump. Doses will be repeated every 3 weeks or at a dosing frequency as agreed to by the Safety Review Committee. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0605
Date of REC Opinion
30 Jan 2018
REC opinion
Further Information Favourable Opinion