RecruitingPhase 1NCT06458712

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies

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


Sponsor

Duke Street Bio Ltd

Enrollment

90 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new experimental drug called DSB2455 in people with advanced solid tumors (cancers that have spread or cannot be removed by surgery). The goal is to find out how safe the drug is and what doses the body can tolerate. **You may be eligible if...** - You are 18 or older - You have advanced cancer with measurable disease on standard imaging - Your functional status is good (ECOG 0–1) and you have a life expectancy of at least 12 weeks - You can provide a tissue sample from your tumor (either from a prior biopsy or a new biopsy) - You are willing to follow the study schedule **You may NOT be eligible if...** - You do not have measurable disease - Your performance status or organ function does not meet the required levels - You cannot provide a tumor tissue sample - You have other serious medical conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDSB2455

PARP1 inhibitor


Locations(13)

Yale Cancer Center - Yale New Haven Hospital

New Haven, Connecticut, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Institut Bergonie

Bordeaux, France

Institut Godinot

Reims, France

START La Rioja, Hospital Universitario San Pedro

Logroño, La Rioja, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

START Barcelona, CIOCC, Hospital Universitario Nou Delfos

Barcelona, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Hospital 12 de Octubre

Madrid, Spain

START Madrid-CIOCC, Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Universitary Hospital Virgen del Rocio

Seville, Spain

Instituto Valenciano de Oncologia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06458712