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A Study of DB-1310 in Advanced Solid Tumors

This study is testing a new drug called DB-1310, alone or in combination with other approved drugs like Trastuzumab, Osimertinib, or capecitabine. It's for adults with advanced solid tumors that have either come back, gotten worse after standard treatments, or for which there are no standard treatments available. The main goals are to find a safe dose of DB-1310 and to understand its side effects. Researchers will also look at how well the treatments work. The study is currently recruiting up to 1000 participants.

Study design
This is an open-label (meaning you and your doctors will know which treatment you are receiving) Phase 1/2a study. It will involve multiple doses and aims to enroll up to 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects for approximately one year after your treatment ends.

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

NCT05785741

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
DualityBio Inc.
~1,000 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:DB-1310TrastuzumabOsimertinibcapecitabine

At a glance

Recruiting sites
21 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: 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
+7 more outcomes measured

Conditions

Advanced Solid Tumor

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Where it's being run

24 sites across 16 states
Florida6
California2
Jiangsu2
Sichuan2
Georgia1
Massachusetts1
Michigan1
New Jersey1

Study leadership

  • Lily Hu · STUDY_DIRECTOR · DualityBio Inc.

Who to contact

Tiana Zhao
[email protected]
1-626-433-3820
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation 10. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. 11. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration. 12. Phase 1 monotherapy subjects (Phase 1 monotherapy ONLY):
Pathologically documented advanced/unresectable, or metastatic solid tumors that is refractory to or intolerable with standard treatment, or for which standard treatment is not available.

What this trial measures

  • Phase 1: 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 Part 1 with DLTs

  • Phase 1: 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 TEAE in Part 1 graded according to NCI CTCAE v5.0

  • Phase 1: 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 Part 1 graded according to NCI CTCAE v5.0

  • Maximum Tolerated Dose (MTD) of DB-131012 months

    MTD on the data collected during Part 1

  • Phase 1: Recommended Phase 2 Dose (RP2D) of DB-131012 months

    RP2D of DB-1310 based on the data collected during Part 1

  • Phase 2a: 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 TEAE in Part 2 graded according to NCI CTCAE v5.0

  • Phase 2a: Percentage 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 Part 2 graded according to NCI CTCAE v5.0

  • Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.Up to follow-up period, approximately 1 year post-treatment

    The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks