US-based Helix BioPharma has started patient enrolment for the 12th dose level group in its ongoing Phase I/II clinical safety, tolerability and preliminary efficacy trial of L-DOS47 in Poland (LDOS002).
L-DOS47 is the company's first immunoconjugate-based drug candidate being developed upon its new DOS47 technology and is currently being evaluated in two clinical trials.
The trial steering committee reviewed the safety data for the eleventh group and recommended that the company can start enrolment into the 12th group as no dose limiting toxicities were observed.
The open-label Phase I/II trial LDOS002 is designed to evaluate the safety, tolerability and preliminary efficacy of ascending doses of L-DOS47, initially as a monotherapy, in patients with inoperable, locally advanced, recurrent or metastatic, non-squamous, stage IIIb/IV non-small cell lung cancer (NSCLC).
The trial started with a starting dose of 0.12µg of L-DOS47 per kilogram of patient body weight in the first patient group.
Patients to be enrolled in the 12th group will receive the next L-DOS47 dose level as planned in the study protocol, which is 4.33µgof L-DOS47 per kilogram of patient body weight.
LDOS001 is an open label, dose escalation Phase I trial and its primary objective is to determine the safety and tolerability of L-DOS47 in combination treatment with pemetrexed/carboplatin.
The Phase I trial will also evaluate the potential clinical benefit of L-DOS47 with this combination, while other exploratory objectives include the evaluation of the L-DOS47 pharmacokinetics and immunogenicity.
Helix CEO Robert Verhagen said: "We continue to be encouraged with the safety profile of L-DOS47 and we look forward to continued dose escalation, as we expect that this will provide more flexibility in later stages of clinical development."
In February 2015, the Central Ethics Committee overseeing the Phase I trial in Poland approved additional dose levels in the Phase I component of the LDOS002 trial in anticipation of continued dose escalation beyond the 4.33µg/kg in group 12.