NCT07141706

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_1

Timeline
25mo left

Started Sep 2025

Typical duration for phase_1

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

August 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

September 23, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

August 18, 2025

Last Update Submit

April 7, 2026

Conditions

Advanced/Metastatic Solid Tumors

Keywords

ADAM9Solid tumorDB-1317

Outcome Measures

Primary Outcomes (11)

  • Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

    Percentage of participants in Phase 1a with DLTs

    up to 21 days after Cycle 1 Day 1

  • Phase 1a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.

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

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

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

    Up to follow-up period, approximately 1 year post-treatment

  • Maximum Tolerated Dose (MTD) of DB-1317

    MTD on the data collected during Phase 1a

    Up to the completion of Phase 1a (assessed up to 12 months)

  • Recommended Phase 1b Dose (RP2D) of DB-1317

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

    Up to the completion of Phase 1a (assessed up to 12 months)

  • Phase 1b: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.

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

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1b: Percentage of participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

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

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1b: Objective Response Rate (ORR) as determined by investigator

    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

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1b: duration of response (DoR)

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

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1b: disease-control rate (DCR)

    DCR will be determined from tumor assessments by investigator per response

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1b: Time to Response (TTR)

    TTR will be determined from tumor assessments by investigator per response

    Up to follow-up period, approximately 1 year post-treatment

Secondary Outcomes (13)

  • Phase 1a: Objective response rate (ORR)

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1a: duration of response (DoR)

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1a: disease-control rate (DCR)

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1a: Time to Response (TTR)

    Up to follow-up period, approximately 1 year post-treatment

  • Phase 1a & Phase 1b: Progression Free Survival (PFS)

    Up to follow-up period, approximately 1 year post-treatment

  • +8 more secondary outcomes

Study Arms (8)

DB-1317 Dose Level 1

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W

Drug: DB-1317

DB-1317 Dose Level 2

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W

Drug: DB-1317

DB-1317 Dose Level 3

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W

Drug: DB-1317

DB-1317 Dose Level 4

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W

Drug: DB-1317

DB-1317 Dose Level 5

EXPERIMENTAL

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W

Drug: DB-1317

DB-1317 Dose Expansion 1

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Drug: DB-1317

DB-1317 Dose Expansion 2

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Drug: DB-1317

DB-1317 Dose Expansion 3

EXPERIMENTAL

Subjects with advanced/unresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317

Drug: DB-1317

Interventions

DB-1317DRUG

Administered I.V.

DB-1317 Dose Expansion 1DB-1317 Dose Expansion 2DB-1317 Dose Expansion 3DB-1317 Dose Level 1DB-1317 Dose Level 2DB-1317 Dose Level 3DB-1317 Dose Level 4DB-1317 Dose Level 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults
  • Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
  • Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.
  • Has a life expectancy of ≥ 3 months.
  • Has an ECOG PS of 0-1.
  • Has LVEF ≥ 50% within 28 days before enrollment.
  • Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.
  • Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods

You may not qualify if:

  • Prior treatment with ADAM9 targeted therapy.
  • Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.
  • Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.
  • Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
  • Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
  • Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 ms in males and females
  • Has a history of (non-infectious) ILD/pneumonitis
  • Has a lung-specific intercurrent clinically significant illness
  • Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.
  • Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;
  • Known chronic, active, or uncontrolled hepatitis C
  • Has clinically significant corneal disease.
  • Has clinically active brain metastases
  • Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \< 3 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

USA04-0

Los Angeles, California, 90025, United States

RECRUITING

Site USA06-0

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

USA02-0

Houston, Texas, 77030, United States

RECRUITING

USA03-0

San Antonio, Texas, 78229, United States

RECRUITING

USA01

Fairfax, Virginia, 22031, United States

RECRUITING

AUS01-0

Randwick, New South Wales, 2031, Australia

RECRUITING

Study Officials

  • Lily Hu

    DualityBio Inc.

    STUDY DIRECTOR

Central Study Contacts

Junhua Gao

CONTACT

01067228087junhua.gao@dualitybiologics.com

Michael Sun

CONTACT

michael.sun@dualitybiologics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 26, 2025

Study Start

September 23, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(5)AU(1)