Recruiting
Phase 1

DB-1317

Sponsor:

DualityBio Inc.

Code:

NCT07141706

Conditions

Advanced/Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DB-1317

Study Details

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 one randomized dose expansion cohort and two single-arm 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

Study ID

NCT07141706

Start date

Sep 23, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Male or female adults
2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
3. 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.
4. Has a life expectancy of ≥ 3 months.
5. Has an ECOG PS of 0-1.
6. Has LVEF ≥ 50% within 28 days before enrollment.
7. 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.
8. Male and female participants of reproductive/childbearing potential must agree to use adequate contraceptive methods

Key Exclusion Criteria:

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

253 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DB-1317 Dose Level 1

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

experimental: DB-1317 Dose Level 2

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

experimental: DB-1317 Dose Level 3

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

experimental: DB-1317 Dose Level 4

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

experimental: DB-1317 Dose Level 5

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

experimental: DB-1317 Dose Expansion 1

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

experimental: DB-1317 Dose Expansion 2

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

experimental: DB-1317 Dose Expansion 3

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

experimental: DB-1317 Dose Level 6

Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 6 on Day 1 of each cycle Q2W

Interventions

DB-1317

Administered I.V.

Primary outcome measure

  • Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Maximum Tolerated Dose (MTD) of DB-1317 [ Time Frame: Up to the completion of Phase 1a (assessed up to 12 months) ]
  • Recommended Phase 1b Dose (RP2D) of DB-1317 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Phase 1b: Objective Response Rate (ORR) as determined by investigator [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Phase 1b: duration of response (DoR) [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Phase 1b: disease-control rate (DCR) [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
  • Phase 1b: Time to Response (TTR) [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]

Central Contacts and Locations

Locations

USA04-0

Recruiting

Los Angeles, California, United States, 90025

USA05-0

Recruiting

Ann Arbor, Michigan, United States, 48109

Site USA06-0

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

USA02-0

Recruiting

Houston, Texas, United States, 77030

USA03-0

Recruiting

San Antonio, Texas, United States, 78229

USA01-0

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

DualityBio Inc.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • ADAM9
  • Solid tumor
  • DB-1317

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DualityBio Inc. on 2026-07-27.