Phase Ia/Ib Open Label, Multi-Centre Dose Escalation Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy or in Combination With Anti-Cancer Agents in Participants With Advanced Malignancies
Study Identifier:
DSB2455-001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To assess the safety, tolerability, and activity of DSB2455 as monotherapy or in combination with anti-cancer agents in participants with advanced malignancies
Study consists of dose escalation (DEsc) Part A and dose expansion (DExp) Part B to further evaluate the activity and safety of DSB2455.
Pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers will be assessed throughout the study.
To investigate PD and exploratory biomarkers to aid understanding of PK-PD, Exposure-Response and Exposure-Safety relationships.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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.
- * 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
- DExp will consist of 4 cohorts: mCRPC, Ovarian cancer, Breast cancer and secondary Brain metastasis with BRCA1/2 mutations or other HRD.
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.
- * 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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START La Rioja
Logroño, La Rioja, Spain, 26006
Investigator
Maria de Miguel
Status
Recruiting
Condition(s) Treated at Site
Breast
Ovarian
Prostate
Neuroendocrine
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Ramon Yarza
Status
Recruiting
Condition(s) Treated at Site
Breast
Ovarian
Prostate
Neuroendocrine
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Roberto Martin Huertas
Status
Will Be Recruiting
Condition(s) Treated at Site
Breast
Ovarian
Prostate
Neuroendocrine