First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
NCT ID: NCT06554795
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
360 participants
INTERVENTIONAL
2024-09-03
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Level 1
Enrolled subjects will receive DB-1419 at Dose Level 1
DB-1419
Administered Injection of Vein (I.V.)
Dose Level 2
Enrolled subjects will receive DB-1419 at Dose Level 2
DB-1419
Administered Injection of Vein (I.V.)
Dose Level 3
Enrolled subjects will receive DB-1419 at Dose Level 3
DB-1419
Administered Injection of Vein (I.V.)
Dose Level 4
Enrolled subjects will receive DB-1419 at Dose Level 4
DB-1419
Administered Injection of Vein (I.V.)
Dose Level 5
Enrolled subjects will receive DB-1419 at Dose Level 5
DB-1419
Administered Injection of Vein (I.V.)
Dose Level 6
Enrolled subjects will receive DB-1419 at Dose Level 6
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 1
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 2
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 3
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 4
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 5
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 6
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 7
DB-1419
Administered Injection of Vein (I.V.)
Dose Expansion 8
DB-1419
Administered Injection of Vein (I.V.)
Interventions
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DB-1419
Administered Injection of Vein (I.V.)
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Has a life expectancy of ≥ 3 months.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
7. Has adequate organ function within 7 days prior to the first dose of study treatment.
8. Has adequate treatment washout period prior to the first dose of study treatment.
9. Is willing to provide pre-existing resected tumor samples when available or undergo fresh tumor biopsy if feasible for the measurement of B7-H3/PD-L1 level and other biomarkers if no contraindication.
Note: there is no minimum B7-H3/PD-L1 expression level mandatory for entry into the study.
10. 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.
Exclusion Criteria
2. Has a medical history of symptomatic congestive heart failure (New York Heart Association \[NYHA\] classes II-IV or serious cardiac arrhythmia requiring treatment.
3. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
4. 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.
5. 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.
6. 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.
7. 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.
8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals within 2 weeks before first dose of study treatment.
9. Know human immunodeficiency virus (HIV) infection.
10. 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 (defined as 2 brain images, same imaging modality, both of which are obtained after treatment to the brain metastases; these imaging scans should be obtained at least 4 weeks apart and show no evidence of intracranial progression), and are on stable or decreasing doses of corticosteroids equivalent to ≤10 mg/day prednisone are eligible for study entry.
18 Years
ALL
No
Sponsors
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DualityBio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lily Hu
Role: STUDY_DIRECTOR
DualityBio Inc.
Locations
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Site USA12-0
Los Angeles, California, United States
Site USA08-0
Newport Beach, California, United States
Site USA13-0
Sacramento, California, United States
Site USA06-0
Washington D.C., District of Columbia, United States
Site USA02-0
Florida City, Florida, United States
Site USA11-0
Chicago, Illinois, United States
Site USA03
Huntersville, North Carolina, United States
Site USA05-0
Philadelphia, Pennsylvania, United States
Site USA07-0
Nashville, Tennessee, United States
Site USA09-0
West Valley City, Utah, United States
AUS03-0
North Ryde, New South Wales, Australia
AUS01-0
Randwick, New South Wales, Australia
AUS02-0
Nedlands, Western Australia, Australia
Site CHN24-0
Hefei, Anhui, China
Site CHN28-0
Beijing, Beijing Municipality, China
Site CHN16-0
Chongqing, Chongqing Municipality, China
Site CHN20-0
Fuzhou, Fujian, China
Site CHN32-0
Nanning, Guangxi, China
Site CHN08-0
Harbin, Heilongjiang, China
Site CHN23-0
Harbin, Heilongjiang, China
Site CHN03-0
Luoyang, Henan, China
Site CHN09-0
Zhengzhou, Henan, China
Site CHN25-0
Zhengzhou, Henan, China
Site CHN21-0
Changsha, Hunan, China
Site CHN29-0
Jinan, Shandong, China
Site CHN26-0
Linyi, Shandong, China
Site CHN01-0
Shanghai, Shanghai Municipality, China
Site CHN15-0
Shanghai, Shanghai Municipality, China
Site CHN18-0
Chengdu, Sichuan, China
Site CHN38-0
Tianjin, Tianjin Municipality, China
Site CHN19-0
Kunming, Yunnan, China
Site CHN17-0
Hangzhou, Zhejiang, China
Site CHN37-0
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jennifer Senior Clinical Trial Coordinator
Role: primary
References
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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.
Other Identifiers
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DB-1419-O-1001
Identifier Type: -
Identifier Source: org_study_id