Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Duke Street Bio Ltd
- Study ID
- NCT06458712
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Metastases)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- DSB2455 — DRUGPARP1 selective inhibitor
Study Details
Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.
Key Dates
- Start date
- Nov 21, 2024
- Status verified
- May 2026
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: DSB2455 Dose Escalation & ExpansionDSB2455 Dose Escalation \& Expansion
Primary Outcome Measure
Number of patients demonstrating dose limiting toxicities and SAEs [ Time Frame: Through study completion, an average of 1 year ]
Central Contacts
- Duke Street Bio+44 (0)203 890 8710
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale Cancer Center - Yale New Haven Hospital | New Haven | Connecticut | 06520 | |
| Tisch Cancer Institute Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | |
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 |