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A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

NCT07141706 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2026-04-09

No results posted yet for this study

Summary

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Conditions

  • Advanced/Metastatic Solid Tumors

Interventions

DRUG

DB-1317

Administered I.V.

Sponsors & Collaborators

  • DualityBio Inc.

    lead INDUSTRY

Principal Investigators

  • Lily Hu · DualityBio Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07141706 on ClinicalTrials.gov