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RecruitingNCT06458712Updated Sep 2, 2026

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

A Phase 1 interventional study of DSB2455 in Advanced Cancers (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Mets) With Specific Mutations (Homologous Recombination Deficiency), sponsored by Duke Street Bio Ltd. Recruiting at 21 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Duke Street Bio Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Advanced Cancers (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Mets) With Specific Mutations (Homologous Recombination Deficiency)

Keywords

  • BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D, Breast, Ovarian, Prostate (mCRPC), Pancreatic Ductal Adenocarcinoma (PDAC), Brain Mets/ Metastases
03

In context

Lead sponsor

This is the only study on the registry with Duke Street Bio Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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.
  • Histologically confirmed diagnosis of locally advanced and/or metastatic breast cancer, prostate cancer (mCRPC), ovarian cancer, or pancreatic ductal adenocarcinoma (PDAC) with confirmed gene alterations/ mutations as defined in the protocol
  • Has received prior cancer treatment as outlined in the protocol
  • Has measurable disease per RECIST v1.1, or non-measurable disease as defined in the protocol.
  • ECOG performance status of 0 to 1.
  • Life expectancy >12 weeks.
  • Adequate organ function as defined in the protocol.
  • Willing and able to comply with scheduled visits (including follow-up visits), and protocol procedures.
  • Willing and able to undergo imaging procedures as per protocol.
  • Willing to provide blood samples for correlative research purposes.
  • Able to swallow oral medication as an intact dosage form.
  • Prior intervention with an approved non-selective PARP inhibitor is permitted in Dose Escalation only.
  • Has received prior cancer treatment as outlined in the protocol, dependent on disease type.
  • Known asymptomatic or symptomatic brain metastasis, as confirmed by an MRI brain scan, from a primary tumour and meeting the eligibility for the disease types noted above (Dose Expansion only, specific Cohort).

Exclusion criteria

Exclusion Criteria:

  • Myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML) or features suggestive of MDS/AML.
  • Has received a prior PARP1-selective inhibitor.
  • Has received prior systemic anti-cancer therapy including investigational agents or device within 2 or 4 weeks prior to study intervention, dependent on the treatment.
  • Received prior radiotherapy within 2 weeks of the start of study intervention or has a history of radiation pneumonitis.
  • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: administration of killed vaccines are allowed.
  • Has had an allogeneic tissue/solid organ transplant.
  • Has an active autoimmune disease that has required systemic intervention in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
  • History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Refractory nausea and vomiting, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs.
  • Undergone major surgery, open biopsy or significant traumatic injury ≤28 days prior to starting study intervention.
  • Has an active infection requiring systemic therapy or an uncontrolled concurrent illness.
  • Known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by the local health authority.
  • Known history of Hepatitis B or known active Hepatitis C virus (HCV)
  • Cirrhosis of the liver.
  • Clinically significant pulmonary illness.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Participants with a healing, serious or open wound, ulcer, or bone fracture within 28 days prior to first dose of study intervention.
  • History or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participants involvement for the full duration of the study.
  • A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to starting the study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Weight loss of >5% in the 8-week period prior to starting study intervention.
  • Known allergy or hypersensitivity to any of the formulation components of DSB2455.
  • Has received radiation therapy to the lung that is >30Gy within 6 months of the first dose of study intervention.
  • Other disease-specific criteria as outlined in the protocol.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    DSB2455 Dose Escalation & Expansion

    DSB2455 Dose Escalation \& Expansion

    Drug: DSB2455

Interventions

  • DrugDSB2455

    PARP1 selective inhibitor

06

What researchers measure

Primary outcomes

  1. Number of patients demonstrating dose limiting toxicities and SAEs

    Number of patients demonstrating dose limiting toxicities and SAEs

    Time frame: Through study completion, an average of 1 year

  2. Number of patients exhibiting reduction in tumor size.

    Objective Response Rate (ORR)

    Time frame: Through study completion, an average of 1 year

07

Study locations

21 of 21 sites recruiting
  • UC Davis Medical Centre
    Sacramento, California 95817, United States
    Recruiting
  • Yale Cancer Center - Yale New Haven Hospital
    New Haven, Connecticut 06520, United States
    Recruiting
  • Tisch Cancer Institute Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
  • The University of Texas M. D. Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • Institut Bergonie
    Bordeaux, 33000, France
    Recruiting
  • Institut Godinot
    Reims, 51100, France
    Recruiting
  • Orszagos Onkologiai Intezet
    Budapest, 1122, Hungary
    Recruiting
  • Centrum Terapii Wspolczesnej
    Lodz, 90-338, Poland
    Recruiting
  • Polish Mother's Memorial Hospital - Research Institute
    Lodz, Poland
    Recruiting
  • Uniwersytecki Szpital Kliniczny w Poznaniu
    Poznan, 60-569, Poland
    Recruiting
  • START La Rioja, Hospital Universitario San Pedro
    Logroño, La Rioja 26006, Spain
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, Spain
    Recruiting
  • START Barcelona, CIOCC, Hospital Universitario Nou Delfos
    Barcelona, Spain
    Recruiting
  • Hospital Universitario Reina Sofía
    Córdoba, Spain
    Recruiting
  • Clinica Universidad de Navarra - Madrid
    Madrid, 28027, Spain
    Recruiting
  • Hospital 12 de Octubre
    Madrid, Spain
    Recruiting
  • START Madrid-CIOCC, Hospital Universitario HM Sanchinarro
    Madrid, Spain
    Recruiting
  • Hospital Universitario Virgen de la Victoria
    Málaga, 29010, Spain
    Recruiting
  • Clinica Universidad de Navarra - Pamplona
    Pamplona, 31008, Spain
    Recruiting
  • Universitary Hospital Virgen del Rocio
    Seville, 41013, Spain
    Recruiting
  • Instituto Valenciano de Oncologia
    Valencia, 46009, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06458712
Lead sponsor
Duke Street Bio Ltd
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Nov 21, 2024
Primary completion
Aug 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Duke Street Bio
Contact
clinicaltrials@dukesb.com
+44 (0)203 890 8710

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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