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Clinical Trials in Taiwan / NCT06953089
Recruiting Phase 2

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

NCT06953089 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 2
Started
2025-07-18
Last updated
2026-05-22

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

DB-1311/BNT324BNT327 →DB-1305/BNT325 →

DB-1311/BNT324: Administered I.V.

BNT327: Administered I.V.

DB-1305/BNT325: Administered I.V.

Study summary

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent. * At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria. * Has a life expectancy of ≥ 3 months. * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 * Has adequate organ function within 7 days prior to enrollment/randomization, * Has adequate treatment washout period prior to the first dose of trial treatment. * For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score. * For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology * For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma. * For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease. * For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local/ or systemic therapies)/ (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. * For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC. Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations * For PSOC: Must have PSOC, defined as radiographically documented disease recurrence or progression occurring \>6 months after completion of the last dose of platinum-based chemotherapy. * For PDAC: Participants must have histologically or cytologically confirmed metastatic PDAC., who have progressed after at least one prior line of standard systemic treatment ((≥2L PDAC).) * For breast cancer: * HR+/HER2-low or HR+/HER2-ultralow or HR+/HER2-negative BC participants: Pathologically or cytologically documented HR-positive unresectable or metastatic BC with HER2-low, HER2-ultralow or HER2-negative expression. * Triple negative breast cancer (TNBC): Pathologically or cytologically documented unresectable or metastatic TNBC * For mCRC: Participants who have metastatic CRC and have relapsed or progressed after 1 prior line of systemic treatment including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or have relapsed or progressed after 2 lines of therapy if the participant has received targeted therapy * For mCRPC: Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC Exclusion Criteria: * 1\. Prior treatment with B7H3 targeted therapy. * Prior treatment with antibody-drug conjugate with topoisomerase inhibitor. * Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment. * Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs. * Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy. * Has a history of (non-infectious) ILD/pneumonitis. * Any autoimmune, connective tissue or inflammatory disorders. * Has spinal cord compression or clinically active central nervous system (CNS) metastases. * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
USA06-0 Los Angeles California Recruiting
USA16-0 Los Angeles California Recruiting
USA01-0 Wheat Ridge Colorado Recruiting
USA08-0 Florida City Florida Recruiting
USA10-0 Atlanta Georgia Recruiting
USA11-0 Bethesda Maryland Recruiting
USA14-0 Lincoln Nebraska Recruiting
USA04-0 New York New York Recruiting
USA15-0 Portland Oregon Recruiting
USA03-0 Charleston South Carolina Recruiting
USA13-0 Anderson Texas Recruiting
USA12-0 Houston Texas Recruiting
USA05-0 Virginia Beach Virginia Recruiting
USA09-0 Puyallup Washington Recruiting
USA07-0 Spokane Washington Recruiting
AUS07-0 North Sydney New South Wales Recruiting
AUS06-0 Benowa Queensland Recruiting
AUS04-0 Birtinya Queensland Recruiting
AUS05-0 Adelaide South Australia Recruiting
CHN02-0 Beijing Beijing Municipality Recruiting
CHN13-0 Beijing Beijing Municipality Recruiting
CHN23-0 Beijing Beijing Municipality Recruiting
CHN17-0 Dongguan Guangdong Recruiting
CHN06-0 Henan Henan Recruiting
CHN12-0 Xinxiang Henan Recruiting
CHN04-0 Hubei Hubei Recruiting
CHN26-0 Wuhan Hubei Recruiting
CHN34-0 Wuhan Hubei Recruiting
CHN11-0 Changsha Hunan Recruiting
CHN16-0 Xuzhou Jiangsu Recruiting
CHN35-0 Shenyang Liaoning Recruiting
CHN25-0 Xi'an Shaanxi Recruiting
CHN04-0 Shanghai Shanghai Municipality Recruiting
CHN01-0 Shanghai Shanghai Municipality Recruiting
CHN24-0 Chengdu Sichuan Recruiting
TWN01-0 Taipei Taipei Recruiting
TWN02-0 Taipei Taipei Recruiting

More DualityBio Inc. trials in Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06953089 on ClinicalTrials.gov ↗ ← All trials in Taiwan