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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Trial sites expanded: 18 → 21 locationsv16
  2. Trial sites expanded: 15 → 18 locations
    • Eligibility criteria expanded, about 15 words
    v15
  3. Study sites: 14 to 15v14
  4. Primary completion pushed from Aug 2027 to Aug 2028v13 Show 4 more changesShow less
    • Enrollment increased: 90 → 180 participants
    • Study completion pushed from Aug 2028 to Dec 2028
    • Study sites: 13 to 14
    • Eligibility criteria revised
  5. Site details revised at 1 of 13 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 12 to 13v11
  2. Study sites: 10 to 12v10
  3. Study sites: 7 to 10
    • Eligibility criteria expanded, about 40 words
    v9
  4. Study sites: 6 to 7v8
  5. Study sites: 4 to 6v7
  6. Study sites: 2 to 4v6
  7. Site contacts updated at 2 of 2 sitesv5
  8. Study sites: 1 to 2v4
  9. Start date changed from estimate of Nov 2024 to Nov 21, 2024v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2024 to Nov 2024
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Open label, multi-centre, Phase Ia/b adaptive design study with an initial 2-stage Dose Escalation Phase followed by a Dose Expansion Phase.
Trial Details
NCT Number NCT06458712
Lead Sponsor Duke Street Bio Ltd
Conditions
(from sponsor)		 Advanced Cancers (Breast, Ovarian, mCRPC, Pancreatic Ductal Adenocarcinoma (PDAC), Brain Mets) With Specific Mutations (Homologous Recombination Deficiency)
Related terms Anophthalmia with pulmonary hypoplasia, Fanconi Anemia, Complementation Group D1, Fanconi Anemia, Complementation Group N
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov