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NCT06458712 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases), sponsored by Duke Street Bio.

Recruiting
Registry status
Phase 1
Development phase
90
Enrollment target
13
Study locations

NCT06458712: Recruiting Phase 1 study of Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases), sponsored by Duke Street Bio.

NCT06458712 is a Phase 1 study of Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases) that is actively recruiting participants, run by Duke Street Bio. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). The trial reports 13 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06458712, a Phase 1 study of Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases), is actively recruiting participants, sponsored by Duke Street Bio.

RECRUITING
Registry status
Phase 1
Development phase
90 participants
Enrollment target
13
Study locations

Study 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.

Primary Outcome

Number of patients demonstrating dose limiting toxicities and SAEs

Interventions

  • DRUG DSB2455

Study Locations (13)

Other

  • Institut Bergonie - Bordeaux
  • Institut Godinot - Reims
  • Hospital Universitari Vall d'Hebron - Barcelona
  • START Barcelona, CIOCC, Hospital Universitario Nou Delfos - Barcelona
  • Hospital Universitario Reina Sofía - Córdoba
  • Hospital 12 de Octubre - Madrid
  • START Madrid-CIOCC, Hospital Universitario HM Sanchinarro - Madrid
  • Hospital Universitario Virgen de la Victoria - Málaga
  • Universitary Hospital Virgen del Rocio - Seville
  • Instituto Valenciano de Oncologia - Valencia

Connecticut

  • Yale Cancer Center - Yale New Haven Hospital - New Haven

Texas

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

La Rioja

  • START La Rioja, Hospital Universitario San Pedro - Logroño

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-11-21
Est. Completion 2028-08
Phase Phase 1
Duke Street Bio

1 total trials

What NCT06458712 shows while recruiting

NCT06458712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).

The record links to 1 condition, with Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases) appearing as the primary indexed condition, and to 1 intervention - of which DSB2455 is the first listed.

NCT06458712 lists 13 locations in 4 states (Other, Connecticut, Texas).

Frequently Asked Questions

What is clinical trial NCT06458712 about?

NCT06458712 is a clinical study titled "Study to Assess Safety, Tolerability and Activity of DSB2455 in Participants With Advanced Malignancies". 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.

What is the current status of trial NCT06458712?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2024-11-21. Estimated completion is 2028-08.

What conditions does trial NCT06458712 study?

This clinical trial studies the following conditions: Advanced Malignancies With Homologous Recombination Deficiency (HRD) (Breast, Ovarian, mCRPC, Brain Metastases).

What interventions are being tested in trial NCT06458712?

The interventions under investigation include: DSB2455 (DRUG).

Who is sponsoring clinical trial NCT06458712?

This trial is sponsored by Duke Street Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06458712 being conducted?

This trial has 13 study locations across Connecticut, Texas, La Rioja. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06458712's enrollment target sits among peer trials

90 628th of 2000 higher than 1,352 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06458712, the US trial registry maintained by the National Library of Medicine. NCT06458712 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.