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NCT06953089PHASE2Recruiting

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

DualityBio Inc.

Start Date

7/18/2025

Completion Date

6/30/2030

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

Detailed Description

This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants. Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC), platinum-resistant ovarian cancer (PROC) or non-small cell lung cancer (NSCLC), platinum-sensitive ovarian cancer (PSOC), pancreatic ductal carcinoma (PDAC), breast cancer, colorectal cancer (CRC), or metastatic castration resistant prostate cancer (mCRPC) are eligible to participate in the trial.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

DB-1311/BNT324

DRUG

BNT327

DRUG

DB-1305/BNT325

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Conditions

Solid Tumors

Locations

USA06-0

Los Angeles, California 90025

United States

USA16-0

Los Angeles, California 90025

United States

USA01-0

Wheat Ridge, Colorado 80033

United States

USA08-0

Florida City, Florida 99208

United States

USA10-0

Atlanta, Georgia 30318

United States

USA11-0

Bethesda, Maryland 20817

United States

USA14-0

Lincoln, Nebraska 68506

United States

USA04-0

New York, New York 10032

United States

USA15-0

Portland, Oregon 97239

United States

USA03-0

Charleston, South Carolina 29425

United States

USA13-0

Anderson, Texas 46011

United States

USA12-0

Houston, Texas 77030

United States

USA05-0

Virginia Beach, Virginia 22031

United States

USA09-0

Puyallup, Washington 98373

United States

USA07-0

Spokane, Washington 99208

United States

AUS07-0

North Sydney, New South Wales 2060

Australia

AUS06-0

Benowa, Queensland 4217

Australia

AUS04-0

Birtinya, Queensland 4575

Australia

AUS05-0

Adelaide, South Australia 5000

Australia

CHN02-0

Beijing, Beijing Municipality 100021

China

CHN13-0

Beijing, Beijing Municipality 100032

China

CHN23-0

Beijing, Beijing Municipality 100142

China

CHN17-0

Dongguan, Guangdong 523000

China

CHN06-0

Henan, Henan 450008

China

CHN12-0

Xinxiang, Henan 453100

China

CHN04-0

Hubei, Hubei 430014

China

CHN26-0

Wuhan, Hubei 00000

China

CHN34-0

Wuhan, Hubei 430079

China

CHN11-0

Changsha, Hunan 410013

China

CHN16-0

Xuzhou, Jiangsu 221000

China

CHN35-0

Shenyang, Liaoning 110042

China

CHN25-0

Xi'an, Shaanxi 710061

China

CHN04-0

Shanghai, Shanghai Municipality 200032

China

CHN01-0

Shanghai, Shanghai Municipality 200120

China

CHN24-0

Chengdu, Sichuan 610041

China

TWN01-0

Taipei, Taipei 0

Taiwan

TWN02-0

Taipei, Taipei 23561

Taiwan