Loading clinical trials...

Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06458712•Duke Street Bio Ltd

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•Provision of formalin-fixed and paraffin embedded (FFPE) is mandatory. If an FFPE sample is not available prior to intervention, then a baseline fresh biopsy is required.
•Has measurable disease per RECIST v1.1
•ECOG performance status of 0 to 1.
•Life expectancy \>12 weeks.
•Willing and able to comply with scheduled visits (including follow-up visits), treatment plan and laboratory tests.
•Willing to provide blood samples for correlative research purposes.
•Able to swallow oral medication as an intact dosage form.
•All participants must have a tumour lesion safely accessible for biopsy.
+3 more 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 within 4 weeks prior to study intervention.
•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.
•Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to Cycle 1 Day 1.
•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.
+16 more criteria

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

Key Dates

Start Date

November 21, 2024

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2028

Last Updated

January 16, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases)

Interventions

DSB2455

DRUG

Contacts

Duke Street Bio

CONTACT

+44 (0)203 890 8710 clinicaltrials@dukesb.com