RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-21

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06458712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * Participants may have received up to one prior line of therapy with a PARP inhibitor-based regimen in a first-line setting. * Histologically confirmed diagnosis of locally advanced and/or metastatic breast cancer, prostate cancer or ovarian cancer. * Must have known asymptomatic or symptomatic brain metastasis, as confirmed by an MRI brain scan, from a primary tumour	* 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. * 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. * 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.

Inclusion Criteria

Exclusion 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.
* Participants may have received up to one prior line of therapy with a PARP inhibitor-based regimen in a first-line setting.
* Histologically confirmed diagnosis of locally advanced and/or metastatic breast cancer, prostate cancer or ovarian cancer.
* Must have known asymptomatic or symptomatic brain metastasis, as confirmed by an MRI brain scan, from a primary tumour

* 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.
* 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.
* 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.

Contacts and Locations

Study Contact

Duke Street Bio

CONTACT

+44 (0)203 890 8710

clinicaltrials@dukesb.com

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Duke Street Bio Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21

Study Completion Date2028-08

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

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