Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy in Participants With Advanced Malignancies
Duke Street Bio Ltd
Summary
Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The participant (or legally acceptable representative, if applicable) provides written informed consent for the study. * Aged ≥18 years of age on the day of signing the informed consent. * Has measurable disease per RECIST v1.1, or non-measurable disease as defined in the protocol. * ECOG performance status of 0 to 1. * Life expectancy \>12 weeks. * Adequate organ function as defined in the protocol. * Willing and able to comply with scheduled visits (including follow-up visits), and protocol procedures. * Willing and able to undergo imaging procedures as per protocol. *…