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 inter-participant 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. * Provision of formalin-fixed and paraffin embedded (FFPE) is mandatory. If an FFPE sample is not available prior to intervention, then a baseline fresh biopsy is required. * Has measurable disease per RECIST v1.1 * ECOG performance status of 0 to 1. * Life expectancy \>12 weeks. * Willing and able to comply with scheduled visits (including follow-up visits), treatment plan and laborator…
Interventions
- DrugDSB2455
PARP1 inhibitor
Locations (13)
- Yale Cancer Center - Yale New Haven HospitalNew Haven, Connecticut
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas
- Institut BergonieBordeaux
- Institut GodinotReims
- START La Rioja, Hospital Universitario San PedroLogroño, La Rioja
- Hospital Universitari Vall d'HebronBarcelona