Recruiting
Phase 2

DB-1311, BNT327

Sponsor:

DualityBio Inc.

Code:

NCT06953089

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DB-1311/BNT324

BNT327

DB-1305/BNT325

Study Details

Brief 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

Conditions

Solid Tumors

Study ID

NCT06953089

Start date

Jul 18, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy

Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D (Recommended Phase 2 Dose) and RP2D-1 in target population.

experimental: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy

Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population.

experimental: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic HCC

experimental: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/ metastatic CC

experimental: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic melanoma

experimental: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327

In participants with recurrent/metastatic HNSCC

experimental: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325

In participants with advanced/unresectable metastatic NSCLC

experimental: Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy

Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population.

experimental: Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic PSOC

experimental: Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic PDAC

experimental: Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic breast cancer

experimental: Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic CRC

experimental: Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327

In participants with unresectable advanced/metastatic mCRPC

Interventions

DB-1311/BNT324

Administered I.V.

BNT327

Administered I.V.

DB-1305/BNT325

Administered I.V.

Primary outcome measure

  • Part 1: Number of participants with Dose Limiting Toxicities (DLTs). [ Time Frame: During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days ]
  • Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [ Time Frame: up to follow up period, e.g. up to 72 months. ]
  • Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level] [ Time Frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months ]
  • Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment)by arm and dose level. [ Time Frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months ]

Central Contacts and Locations

Central contacts

Jay Ma

540-808-3925jay.ma@dualitybiologics.com

Qiaoli Jiang

+86-15210642683qiaoli.jiang@dualitybiologics.com

Locations

USA06-0

Recruiting

Los Angeles, California, United States, 90025

USA16-0

Recruiting

Los Angeles, California, United States, 90025

USA01-0

Recruiting

Wheat Ridge, Colorado, United States, 80033

USA08-0

Recruiting

Florida City, Florida, United States, 99208

USA10-0

Recruiting

Atlanta, Georgia, United States, 30318

USA11-0

Recruiting

Bethesda, Maryland, United States, 20817

USA14-0

Recruiting

Lincoln, Nebraska, United States, 68506

USA04-0

Recruiting

New York, New York, United States, 10032

USA15-0

Recruiting

Portland, Oregon, United States, 97239

USA03-0

Recruiting

Charleston, South Carolina, United States, 29425

USA13-0

Recruiting

Anderson, Texas, United States, 46011

USA12-0

Recruiting

Houston, Texas, United States, 77030

USA05-0

Recruiting

Virginia Beach, Virginia, United States, 22031

USA09-0

Recruiting

Puyallup, Washington, United States, 98373

USA07-0

Recruiting

Spokane, Washington, United States, 99208

More Information

Sponsor

DualityBio Inc.

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • B7-H3
  • PD-L1/VEGF-A
  • TROP2 (Trophoblast cell surface antigen 2)
  • ADC (antibody-drug conjugate)
  • HNSCC (head and neck squamous cell carcinoma)
  • HCC (hepatocellular carcinoma)
  • Melanoma
  • NSCLC(non-small cell lung cancer)
  • OC (ovarian cancer)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DualityBio Inc. on 2026-05-22.