Solid Tumor, AdultPhase 1/2NCT06554795
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing DB-1419 in people with Solid Tumor, Adult, run by DualityBio Inc. at 36 sites in 3 countries.
Trial summary
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- DB-1419
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 36 sitesin 3 countries
- Study dates
- 3 Sep 2024to Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
36 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 3 countries
China24 sites, 24 recruiting
- Not yet recruiting
Site CHN28-0
Beijing, Beijing Municipality, 100142
- Recruiting
Site CHN21-0
Changsha, Hunan, 410011
- Recruiting
Site CHN18-0
Chengdu, Sichuan, 610041
- Recruiting
Site CHN16-0
Chongqing, Chongqing Municipality, 400030
- Recruiting
Site CHN20-0
Fuzhou, Fujian, 350000
- Not yet recruiting
Site CHN17-0
Hangzhou, Zhejiang, 310005
- Not yet recruiting
Site CHN37-0
Hangzhou, Zhejiang, 310009
- Recruiting
Site CHN08-0
Harbin, Heilongjiang, 150001
- Not yet recruiting
Site CHN23-0
Harbin, Heilongjiang, 150001
- Not yet recruiting
Site CHN24-0
Hefei, Anhui, 230000
- Not yet recruiting
Site CHN39-0
Hefei, Anhui, 230031
- Not yet recruiting
Site CHN13-0
Jilin City, Changchun, 130000
- Not yet recruiting
Site CHN29-0
Jinan, Shandong, 250117
- Not yet recruiting
Site CHN19-0
Kunming, Yunnan, 650118
- Recruiting
Site CHN26-0
Linyi, Shandong, 276034
- Recruiting
Site CHN03-0
Luoyang, Henan, 471000
- Not yet recruiting
Site CHN32-0
Nanning, Guangxi, 530012
- Recruiting
Site CHN01-0
Shanghai, Shanghai Municipality, 200030
- Recruiting
Site CHN15-0
Shanghai, Shanghai Municipality, 200030
- Not yet recruiting
Site CHN31-0
Shenyang, Liaoning, 110000
- Not yet recruiting
Site CHN38-0
Tianjin, Tianjin Municipality, 300000
- Recruiting
Site CHN34-0
Wuhan, Hubei, 430079
- Not yet recruiting
Site CHN09-0
Zhengzhou, Henan, 450000
- Not yet recruiting
Site CHN25-0
Zhengzhou, Henan, 451191
United States9 sites, 9 recruiting
- Recruiting
Site USA11-0
Chicago, Illinois, 60637
- Recruiting
Site USA02-0
Florida City, Florida, 32827
- Recruiting
Site USA03
Huntersville, North Carolina, 28078
- Recruiting
Site USA12-0
Los Angeles, California, 90095
- Recruiting
Site USA07-0
Nashville, Tennessee, 37203
- Recruiting
Site USA08-0
Newport Beach, California, 92663
- Not yet recruiting
Site USA05-0
Philadelphia, Pennsylvania, 19107
- Recruiting
Site USA06-0
Washington D.C., District of Columbia, 20007
- Recruiting
Site USA09-0
West Valley City, Utah, 84119
Australia3 sites, 3 recruiting
- Recruiting
AUS02-0
Nedlands, Washington, 6009
cancertrialsonc3@linear.org.au
- Recruiting
AUS03-0
North Ryde, New South Wales, 2109
- Recruiting
AUS01-0
Randwick, New South Wales, 2031
About this study
Official title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
Read the detailed description
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants with Advanced/Metastatic Solid Tumors
- Conditions
- Solid Tumor, Adult
- Being tested
- DB-1419
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1419Drug
Administered Injection of Vein (I.V.)
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 1 Receives: Drug: DB-1419 |
| Dose Level 2 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 2 Receives: Drug: DB-1419 |
| Dose Level 3 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 3 Receives: Drug: DB-1419 |
| Dose Level 4 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 4 Receives: Drug: DB-1419 |
| Dose Level 5 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 5 Receives: Drug: DB-1419 |
| Dose Level 6 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 6 Receives: Drug: DB-1419 |
| Dose Expansion 1 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 2 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 3 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 4 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 5 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 6 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 7 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Expansion 8 | Experimental | Not described Receives: Drug: DB-1419 |
| Dose Level 7 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 7 Receives: Drug: DB-1419 |
| Dose Level 8 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 8 Receives: Drug: DB-1419 |
| Dose Level 9 | Experimental | Enrolled subjects will receive DB-1419 at Dose Level 9 Receives: Drug: DB-1419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The percentage of subjects with best overall response of CR and PR
Measured: 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
PFS will be determined from tumor assessments by investigator per RECIST 1.1
Measured: 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
overall survival (OS)
Measured: 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
the area under the concentration-time curve from time zero to the last quantifiable concentration
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: AUC0-tau
the area under the concentration-time curve from time zero to time tau
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: AUCinf
the area under the concentration-time curve from time zero to infinite
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Cmax
peak observed concentration
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Tmax
Time to Cmax
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Ctrough
trough concentration
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: ADA prevalence
the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline)
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: ADA incidence
the proportion of participants having treatment-emergent ADA.
Measured: within 8 cycles (each cycle is 21 days or 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start3 Sep 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lily Hu, Study director, DualityBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554795
- Sponsor's protocol ID
- DB-1419-O-1001
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40499141
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06554795
- Acronym / sponsor ID
- DB-1419-O-1001
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
Detailed description
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants with Advanced/Metastatic Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 1 |
| Dose Level 2 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 2 |
| Dose Level 3 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 3 |
| Dose Level 4 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 4 |
| Dose Level 5 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 5 |
| Dose Level 6 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 6 |
| 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 | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 7 |
| Dose Level 8 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 8 |
| Dose Level 9 | Experimental | Drug: DB-1419Enrolled subjects will receive DB-1419 at Dose Level 9 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-1419Administered Injection of Vein (I.V.) | Drug | 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 |
Primary outcome
Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)
Time frame: Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Percentage of participants with TEAEs graded according to NCI CTCAE v5.0
Phase 1/2a: Percentage of Participants with serious AE (SAE)
Time frame: Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
Percentage of participants with SAEs graded according to NCI CTCAE v5.0
Phase 1a: Maximum Tolerated Dose (MTD)
Time frame: From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.
MTD on the data collected during Part 1
Phase 1a: Recommended Phase 2 Dose (RP2D)
Time frame: From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.
RP2D of DB-1419 based on the data collected during Part 1
Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1
Time frame: 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.
The percentage of subjects with best overall response of CR and PR
11 secondary outcomes
Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: AUC0-tau
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: AUCinf
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Cmax
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Tmax
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: Ctrough
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: ADA prevalence
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Phase 1/2a: ADA incidence
Time frame: within 8 cycles (each cycle is 21 days or 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 40499141Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lily Hu study director
DualityBio Inc.
36 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB-1419 in people with Solid Tumor, Adult, run by DualityBio Inc. at 36 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milly Zang (201-503-5410, milly.zang@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE) (time frame: Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.