Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06458712

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

Led by Duke Street Bio Ltd · Updated on 2026-05-14

180

Participants Needed

14

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant provides written informed consent.
  • Age 18 years or older at the time of consent.
  • Measurable or non-measurable disease as defined by RECIST v1.1 or protocol.
  • ECOG performance status of 0 to 1.
  • Life expectancy greater than 12 weeks.
  • Adequate organ function per protocol.
  • Willing and able to attend scheduled visits and follow study procedures.
  • Willing to undergo imaging as required by protocol.
  • Willing to provide blood samples for research.
  • Able to swallow oral medication intact.
  • Prior treatment with approved non-selective PARP inhibitors allowed in dose escalation phase.
  • Histologically confirmed diagnosis of locally advanced or metastatic breast, prostate, ovarian, or pancreatic cancer with specified gene alterations.
  • Received prior cancer treatments as per protocol based on disease type.
  • Known brain metastases confirmed by MRI and meeting disease-specific eligibility (dose expansion phase only).
Not Eligible

You will not qualify if you...

  • Diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or features suggestive of these.
  • Prior treatment with a PARP1-selective inhibitor.
  • Received systemic anti-cancer therapy including investigational agents within 2 or 4 weeks before study intervention.
  • Radiotherapy within 2 weeks before study start or history of radiation pneumonitis.
  • Immunodeficiency or use of chronic systemic steroids or immunosuppressive therapy within 7 days before first dose.
  • Receipt of live or live-attenuated vaccine within 30 days before first dose (killed vaccines allowed).
  • History of allogeneic tissue or solid organ transplant.
  • Active autoimmune disease requiring systemic treatment in past 2 years.
  • History or current pneumonitis or interstitial lung disease needing steroids.
  • Severe gastrointestinal issues affecting drug absorption.
  • Major surgery, open biopsy, or significant injury within 28 days before study start.
  • Active infection requiring systemic therapy or uncontrolled illness.
  • Known HIV infection.
  • Known Hepatitis B or active Hepatitis C infection.
  • Liver cirrhosis.
  • Significant lung or cardiac disease.
  • Healing or serious wounds, ulcers, or fractures within 28 days before first dose.
  • Conditions or treatments that could interfere with study results or participation.
  • Positive pregnancy test in women of childbearing potential.
  • Psychiatric or substance abuse disorders interfering with study cooperation.
  • Weight loss exceeding 5% in 8 weeks before study start.
  • Allergy to any components of DSB2455.
  • Lung radiation over 30Gy within 6 months before first dose.
  • Other disease-specific exclusion criteria as per protocol.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Yale Cancer Center - Yale New Haven Hospital

New Haven, Connecticut, United States, 06520

Actively Recruiting

2

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

3

Institut Bergonie

Bordeaux, France, 33000

Actively Recruiting

4

Institut Godinot

Reims, France, 51100

Actively Recruiting

5

Orszagos Onkologiai Intezet

Budapest, Hungary, 1122

Actively Recruiting

6

START La Rioja, Hospital Universitario San Pedro

Logroño, La Rioja, Spain, 26006

Actively Recruiting

7

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Actively Recruiting

8

START Barcelona, CIOCC, Hospital Universitario Nou Delfos

Barcelona, Spain

Actively Recruiting

9

Hospital Universitario Reina Sofía

Córdoba, Spain

Actively Recruiting

10

Hospital 12 de Octubre

Madrid, Spain

Actively Recruiting

11

START Madrid-CIOCC, Hospital Universitario HM Sanchinarro

Madrid, Spain

Actively Recruiting

12

Hospital Universitario Virgen de la Victoria

Málaga, Spain, 29010

Actively Recruiting

13

Universitary Hospital Virgen del Rocio

Seville, Spain, 41013

Actively Recruiting

14

Instituto Valenciano de Oncologia

Valencia, Spain, 46009

Actively Recruiting

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Research Team

D

Duke Street Bio

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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