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New drug DSB2455 targets Hard-to-Treat cancers in early trial

NCT ID NCT06458712

Disease control Sponsor: Duke Street Bio Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug called DSB2455 in adults with advanced cancers (breast, ovarian, prostate, pancreatic, or brain metastases) that have a specific DNA repair problem. The main goals are to check safety and see if the drug shrinks tumors. About 180 participants will receive the drug in increasing doses to find the best dose with manageable side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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.

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Conditions

The condition(s) this trial relates to.

autosomal recessive Kenny-Caffey syndrome brain cancer breast cancer breast carcinoma castration-resistant prostate carcinoma Fanconi anemia complementation group D1 Fanconi anemia complementation group N Matthew-Wood syndrome metastatic prostate carcinoma ovarian cancer pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancers (breast, ovarian, MCRPC, pancreatic ductal adenocarcinoma (PDAC), brain mets) with specific mutations (homologous recombination deficiency) Advanced malignancies with homologous recombination deficiency (HRD) (breast, ovarian, MCRPC, brain metastases) Advanced malignancies with homologous recombination deficiency (HRD) (breast, ovarian, MCRPC, pancreatic ductal adenocarcinoma (PDAC), brain metastases)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Centrum Terapii Wspolczesnej

    RECRUITING

    Lodz, 90-338, Poland

  • Clinica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Reina Sofía

    RECRUITING

    Córdoba, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33000, France

  • Institut Godinot

    RECRUITING

    Reims, 51100, France

  • Instituto Valenciano de Oncologia

    RECRUITING

    Valencia, 46009, Spain

  • Orszagos Onkologiai Intezet

    RECRUITING

    Budapest, 1122, Hungary

  • Polish Mother's Memorial Hospital - Research Institute

    RECRUITING

    Lodz, Poland

  • START Barcelona, CIOCC, Hospital Universitario Nou Delfos

    RECRUITING

    Barcelona, Spain

  • START La Rioja, Hospital Universitario San Pedro

    RECRUITING

    Logroño, La Rioja, 26006, Spain

  • START Madrid-CIOCC, Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, Spain

    Contact Email: •••••@•••••

  • The University of Texas M. D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Tisch Cancer Institute Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • UC Davis Medical Centre

    RECRUITING

    Sacramento, California, 95817, United States

    Contact Email: •••••@•••••

  • Universitary Hospital Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 60-569, Poland

  • Yale Cancer Center - Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06520, United States

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