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 — DRUG
    PARP1 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 & Expansion
    DSB2455 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

Locations (3)

FacilityCityStateZIPSite coordinators
Yale Cancer Center - Yale New Haven HospitalNew HavenConnecticut06520
Principal Investigator
203-785-4069
Tisch Cancer Institute Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Principal Investigator
212-824-7945
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Principal Investigator
713-563-1784

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