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A Study of DB-1317 for Advanced/Metastatic Solid Tumors

This study is testing a drug called DB-1317, which is an antibody-drug conjugate and a targeted therapy, for people with advanced or metastatic (spread beyond its original site) solid tumors. You might be able to join if you are an adult with certain solid tumors that have continued to grow even after standard treatments. The main goals of the study are to find a safe dose of DB-1317 and to understand its side effects. The study is currently recruiting about 253 participants. The current status of the study is unclear.

Study design
This is a Phase 1a/1b study, meaning it's an early-stage trial. It is open-label, so both you and your doctors will know you are receiving DB-1317. The study will involve multiple doses of DB-1317 given every three weeks.
What's involved
You would receive DB-1317 intravenously (into a vein) every three weeks. The study will monitor for side effects and assess your tumor's response.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to approximately 1 year after your last treatment to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07141706

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
DualityBio Inc.
~253 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:DB-1317

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs
Measured over up to 21 days after Cycle 1 Day 1
+10 more outcomes measured

Conditions

Advanced/Metastatic Solid Tumors

Explore related trials

Solid Neoplasm

NCT07141706

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AUS01-0

    Randwick, New South Wales, Australiano site contact published

    Recruiting

  • AUS02-0

    Nedlands, Western Australia, Australiano site contact published

    Recruiting

  • AUS03-0

    Liverpool, New South Wales, Australiano site contact published

    Recruiting

  • AUS04-0

    Westmead, New South Wales, Australiano site contact published

    Recruiting

  • Chn01-1/Chn01-2

    Guangzhou, Guangdong, Chinano site contact published

    Recruiting

  • CHN03-0

    Zhengzhou, Henan, Chinano site contact published

    Recruiting

  • CHN04-0

    Jinan, Shandong, Chinano site contact published

    Recruiting

  • CHN05-0

    Harbin, Heilongjiang, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lily Hu · STUDY_DIRECTOR · DualityBio Inc.

Who to contact

Junhua Gao
[email protected]
01067228087
Email the study team

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What this trial measures

  • Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTsup to 21 days after Cycle 1 Day 1

    Percentage of participants in Phase 1a with DLTs

  • Phase 1a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.Up to follow-up period, approximately 1 year post-treatment

    Percentage of participants with TEAEs in Phase 1a graded according to NCI CTCAE v5.0

  • Phase 1a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.Up to follow-up period, approximately 1 year post-treatment

    Percentage of Participants with SAEs in Phase 1a graded according to NCI CTCAE v5.0

  • Maximum Tolerated Dose (MTD) of DB-1317Up to the completion of Phase 1a (assessed up to 12 months)

    MTD on the data collected during Phase 1a

  • Recommended Phase 1b Dose (RP2D) of DB-1317Up to the completion of Phase 1a (assessed up to 12 months)

    RP2D of DB-1317 based on the data collected during Phase 1a

  • Phase 1b: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.Up to follow-up period, approximately 1 year post-treatment

    Percentage of participants with TEAEs in Phase 1b graded according to NCI CTCAE v5.0

  • Phase 1b: Percentage of participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.Up to follow-up period, approximately 1 year post-treatment

    Percentage of participants with SAEs in Phase 1b graded according to NCI CTCAE v5.0

  • Phase 1b: Objective Response Rate (ORR) as determined by investigatorUp to follow-up period, approximately 1 year post-treatment

    Phase 1b: Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-CRPC. The percentage of participants who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks

  • Phase 1b: duration of response (DoR)Up to follow-up period, approximately 1 year post-treatment

    DoR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

  • Phase 1b: disease-control rate (DCR)Up to follow-up period, approximately 1 year post-treatment

    DCR will be determined from tumor assessments by investigator per response

  • Phase 1b: Time to Response (TTR)Up to follow-up period, approximately 1 year post-treatment

    TTR will be determined from tumor assessments by investigator per response