First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors

NCT06554795 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DB-1419-O-1001
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 36

Brief Summary

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (5)

• Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)

  Percentage of participants with TEAEs graded according to NCI CTCAE v5.0

  Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first

• Phase 1/2a: Percentage of Participants with serious AE (SAE)

  Percentage of participants with SAEs graded according to NCI CTCAE v5.0

  Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first

• Phase 1a: Maximum Tolerated Dose (MTD)

  MTD on the data collected during Part 1

  From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.

• Phase 1a: Recommended Phase 2 Dose (RP2D)

  RP2D of DB-1419 based on the data collected during Part 1

  From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.

• Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1

  The percentage of subjects with best overall response of CR and PR

  Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.

Secondary Outcomes (11)

• Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1

  Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.

• Phase 1/2a: Progression free survival (PFS) determined from tumor assessments by Investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1

  Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months

• Phase 1/2a: OS

  From the start date of study drug to the date of death due to any cause, whichever occurs first, approximately up to 12 months after last patient first dose.

• Phase 1/2a: AUC0-last

  within 8 cycles (each cycle is 21 days or 14 days)

• Phase 1/2a: AUC0-tau

  within 8 cycles (each cycle is 21 days or 14 days)

Study Arms (17)

Dose Level 1

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 1

Drug: DB-1419

Dose Level 2

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 2

Drug: DB-1419

Dose Level 3

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 3

Drug: DB-1419

Dose Level 4

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 4

Drug: DB-1419

Dose Level 5

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 5

Drug: DB-1419

Dose Level 6

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 6

Drug: DB-1419

Dose Expansion 1

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 2

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 3

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 4

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 5

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 6

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 7

EXPERIMENTAL

Drug: DB-1419

Dose Expansion 8

EXPERIMENTAL

Drug: DB-1419

Dose Level 7

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 7

Drug: DB-1419

Dose Level 8

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 8

Drug: DB-1419

Dose Level 9

EXPERIMENTAL

Enrolled subjects will receive DB-1419 at Dose Level 9

Drug: DB-1419

Interventions

DB-1419 DRUG

Administered Injection of Vein (I.V.)

Dose Expansion 1; Dose Expansion 2; Dose Expansion 3; Dose Expansion 4; Dose Expansion 5; Dose Expansion 6; Dose Expansion 7; Dose Expansion 8; Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5; Dose Level 6; Dose Level 7; Dose Level 8; Dose Level 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥ 18 years at the time of voluntarily signing informed consent.
• Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.
• At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.
• Has a life expectancy of ≥ 3 months.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
• Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
• Has adequate organ function within 7 days prior to the first dose of study treatment.
• Has adequate treatment washout period prior to the first dose of study treatment.
• Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3 level and other biomarkers if no contraindication.
• Note: there is no minimum B7-H3 expression level mandatory for entry into the study.
• Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments.
• Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy during the study and for at least 4 months and 7 months after the last dose of study treatment, respectively.
• Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study treatment administration. Female participants 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 treatment administration.

You may not qualify if:

• Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.
• Has a medical history of symptomatic congestive heart failure (New York Heart Association \[NYHA\] classes II-IV or serious cardiac arrhythmia requiring treatment.
• Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
• Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
• Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis which needs glucocorticoids and antibiotics) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
• Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
• Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.
• Know human immunodeficiency virus (HIV) infection.
• Has active viral hepatitis.
• Is a lactating mother, or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment.
• Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy, and are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg/day prednisone are eligible for study entry.
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 5.0, Grade ≤ 1 or baseline.
• Has a prior history of immune-related adverse event that required permanent immune checkpoint inhibitor discontinuation per NCCN guidelines.

Sponsors & Collaborators

• DualityBio Inc.: lead

Study Sites (36)

Site USA12-0

Los Angeles, California, 90095, United States

RECRUITING

Site USA08-0

Newport Beach, California, 92663, United States

RECRUITING

Site USA06-0

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Site USA02-0

Florida City, Florida, 32827, United States

RECRUITING

Site USA11-0

Chicago, Illinois, 60637, United States

RECRUITING

Site USA03

Huntersville, North Carolina, 28078, United States

RECRUITING

Site USA05-0

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Site USA07-0

Nashville, Tennessee, 37203, United States

RECRUITING

Site USA09-0

West Valley City, Utah, 84119, United States

RECRUITING

AUS03-0

North Ryde, New South Wales, 2109, Australia

RECRUITING

AUS01-0

Randwick, New South Wales, 2031, Australia

RECRUITING

AUS02-0

Nedlands, Washington, 6009, Australia

RECRUITING

Site CHN24-0

Hefei, Anhui, 230000, China

NOT YET RECRUITING

Site CHN39-0

Hefei, Anhui, 230031, China

NOT YET RECRUITING

Site CHN28-0

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

Site CHN13-0

Jilin, Changchun, 130000, China

NOT YET RECRUITING

Site CHN16-0

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Site CHN20-0

Fuzhou, Fujian, 350000, China

RECRUITING

Site CHN32-0

Nanning, Guangxi, 530012, China

NOT YET RECRUITING

Site CHN08-0

Harbin, Heilongjiang, 150001, China

RECRUITING

Site CHN23-0

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

Site CHN03-0

Luoyang, Henan, 471000, China

RECRUITING

Site CHN09-0

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Site CHN25-0

Zhengzhou, Henan, 451191, China

NOT YET RECRUITING

Site CHN34-0

Wuhan, Hubei, 430079, China

RECRUITING

Site CHN21-0

Changsha, Hunan, 410011, China

RECRUITING

Site CHN31-0

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

Site CHN29-0

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Site CHN26-0

Linyi, Shandong, 276034, China

RECRUITING

Site CHN01-0

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Site CHN15-0

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Site CHN18-0

Chengdu, Sichuan, 610041, China

RECRUITING

Site CHN38-0

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Site CHN19-0

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

Site CHN17-0

Hangzhou, Zhejiang, 310005, China

NOT YET RECRUITING

Site CHN37-0

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Related Publications (1)

• Li C, Yao J, Yang J, Zhang Y, Qiu Y, Zhu Z, Hua H. Preclinical Evaluation of DB-1419, a Novel Bifunctional and Bispecific Anti-B7-H3 x PD-L1 Antibody-Drug Conjugate. Clin Cancer Res. 2025 Aug 14;31(16):3581-3593. doi: 10.1158/1078-0432.CCR-25-0634.

  PMID: 40499141 DERIVED

Study Officials

• Lily Hu

  DualityBio Inc.

  STUDY DIRECTOR

Central Study Contacts

Milly Zang

CONTACT

858-375-6788; milly.zang@dualitybiologics.com

Cathy Li

CONTACT

858-375-6788; cathy.li@dualitybiologics.com

Study Design

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

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 15, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); AU (3); CN (24)