New hope for advanced cancer: experimental drug DB-1419 enters human trials

NCT ID NCT06554795

Disease control Sponsor: DualityBio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new experimental drug, DB-1419, in adults with advanced or metastatic solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. About 360 participants will take part across multiple centers.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent. 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 level and other biomarkers if no contraindication. Note: there is no minimum B7-H3 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. 11. 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. 12. 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. Exclusion Criteria: 1. Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload. 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 active viral hepatitis. 11. Is a lactating mother, or pregnant as confirmed by pregnancy tests performed within 7 days prior to enrollment. 12. 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. 13. 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. 14. Has a prior history of immune-related adverse event that required permanent immune checkpoint inhibitor discontinuation per NCCN guidelines. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

36 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

AUS01-0
RECRUITING

Randwick, New South Wales, 2031, Australia
AUS02-0
RECRUITING

Nedlands, Washington, 6009, Australia

Contact Email: •••••@•••••
AUS03-0
RECRUITING

North Ryde, New South Wales, 2109, Australia
Site CHN01-0
RECRUITING

Shanghai, Shanghai Municipality, 200030, China
Site CHN03-0
RECRUITING

Luoyang, Henan, 471000, China
Site CHN08-0
RECRUITING

Harbin, Heilongjiang, 150001, China
Site CHN09-0
NOT_YET_RECRUITING

Zhengzhou, Henan, 450000, China
Site CHN13-0
NOT_YET_RECRUITING

Jilin City, Changchun, 130000, China
Site CHN15-0
RECRUITING

Shanghai, Shanghai Municipality, 200030, China
Site CHN16-0
RECRUITING

Chongqing, Chongqing Municipality, 400030, China
Site CHN17-0
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310005, China
Site CHN18-0
RECRUITING

Chengdu, Sichuan, 610041, China
Site CHN19-0
NOT_YET_RECRUITING

Kunming, Yunnan, 650118, China
Site CHN20-0
RECRUITING

Fuzhou, Fujian, 350000, China
Site CHN21-0
RECRUITING

Changsha, Hunan, 410011, China
Site CHN23-0
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150001, China
Site CHN24-0
NOT_YET_RECRUITING

Hefei, Anhui, 230000, China
Site CHN25-0
NOT_YET_RECRUITING

Zhengzhou, Henan, 451191, China
Site CHN26-0
RECRUITING

Linyi, Shandong, 276034, China
Site CHN28-0
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100142, China
Site CHN29-0
NOT_YET_RECRUITING

Jinan, Shandong, 250117, China
Site CHN31-0
NOT_YET_RECRUITING

Shenyang, Liaoning, 110000, China
Site CHN32-0
NOT_YET_RECRUITING

Nanning, Guangxi, 530012, China
Site CHN34-0
RECRUITING

Wuhan, Hubei, 430079, China
Site CHN37-0
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310009, China
Site CHN38-0
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300000, China
Site CHN39-0
NOT_YET_RECRUITING

Hefei, Anhui, 230031, China
Site USA02-0
RECRUITING

Florida City, Florida, 32827, United States
Site USA03
RECRUITING

Huntersville, North Carolina, 28078, United States
Site USA05-0
NOT_YET_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Site USA06-0
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Site USA07-0
RECRUITING

Nashville, Tennessee, 37203, United States
Site USA08-0
RECRUITING

Newport Beach, California, 92663, United States
Site USA09-0
RECRUITING

West Valley City, Utah, 84119, United States
Site USA11-0
RECRUITING

Chicago, Illinois, 60637, United States
Site USA12-0
RECRUITING

Los Angeles, California, 90095, United States

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