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

NCT06953089 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DB-1311-201
• Study Type: interventional
• Target: 492
• Locations: 4 countries
• Sites: 37

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

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)

Outcome Measures

Primary Outcomes (4)

• Part 1: Number of participants with Dose Limiting Toxicities (DLTs).

  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)

  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]

  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.

  From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

Secondary Outcomes (19)

• Part 1: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment).

  From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

• Part 1 and 2: Duration of response (DoR) per RECIST 1.1 based on the investigator's assessment.

  From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

• Part 1 and 2: Overall survival (OS)

  From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

• Part 1 and 2: Disease-control rate (DCR) per RECIST 1.1 based on the investigator's assessment.

  From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

• Part 1 and 2: Time to response (TTR) per RECIST 1.1 based on the investigator's assessment.

  From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

Study Arms (8)

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

EXPERIMENTAL

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

Drug: DB-1311/BNT324; Drug: BNT327

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

EXPERIMENTAL

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

Drug: DB-1311/BNT324; Drug: DB-1305/BNT325

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

EXPERIMENTAL

In participants with unresectable advanced/metastatic HCC

Drug: DB-1311/BNT324; Drug: BNT327

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

EXPERIMENTAL

In participants with unresectable advanced/ metastatic CC

Drug: DB-1311/BNT324; Drug: BNT327

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

EXPERIMENTAL

In participants with unresectable advanced/metastatic melanoma

Drug: DB-1311/BNT324; Drug: BNT327

Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327

EXPERIMENTAL

In participants with recurrent/metastatic HNSCC

Drug: DB-1311/BNT324; Drug: BNT327

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

EXPERIMENTAL

In participants with advanced/unresectable metastatic NSCLC

Drug: DB-1311/BNT324; Drug: DB-1305/BNT325

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

EXPERIMENTAL

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

Drug: DB-1311/BNT324; Drug: BNT327

Interventions

DB-1311/BNT324 DRUG

Administered I.V.

Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy; Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy; Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy; Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327; Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327; Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327; Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325; Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327

BNT327 DRUG

Administered I.V.

Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy; Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy; Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327; Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327; Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327; Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327

DB-1305/BNT325 DRUG

Administered I.V.

Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy; Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• BioNTech SE: collaborator
• DualityBio Inc.: lead

Study Sites (37)

USA06-0

Los Angeles, California, 90025, United States

RECRUITING

USA16-0

Los Angeles, California, 90025, United States

RECRUITING

USA01-0

Wheat Ridge, Colorado, 80033, United States

RECRUITING

USA08-0

Florida City, Florida, 99208, United States

RECRUITING

USA10-0

Atlanta, Georgia, 30318, United States

RECRUITING

USA11-0

Bethesda, Maryland, 20817, United States

RECRUITING

USA14-0

Lincoln, Nebraska, 68506, United States

RECRUITING

USA04-0

New York, New York, 10032, United States

RECRUITING

USA15-0

Portland, Oregon, 97239, United States

RECRUITING

USA03-0

Charleston, South Carolina, 29425, United States

RECRUITING

USA13-0

Anderson, Texas, 46011, United States

RECRUITING

USA12-0

Houston, Texas, 77030, United States

RECRUITING

USA05-0

Virginia Beach, Virginia, 22031, United States

RECRUITING

USA09-0

Puyallup, Washington, 98373, United States

RECRUITING

USA07-0

Spokane, Washington, 99208, United States

RECRUITING

AUS07-0

North Sydney, New South Wales, 2060, Australia

RECRUITING

AUS06-0

Benowa, Queensland, 4217, Australia

RECRUITING

AUS04-0

Birtinya, Queensland, 4575, Australia

RECRUITING

AUS05-0

Adelaide, South Australia, 5000, Australia

RECRUITING

CHN02-0

Beijing, Beijing Municipality, 100021, China

RECRUITING

CHN13-0

Beijing, Beijing Municipality, 100032, China

RECRUITING

CHN23-0

Beijing, Beijing Municipality, 100142, China

RECRUITING

CHN17-0

Dongguan, Guangdong, 523000, China

RECRUITING

CHN06-0

Henan, Henan, 450008, China

RECRUITING

CHN12-0

Xinxiang, Henan, 453100, China

RECRUITING

CHN04-0

Hubei, Hubei, 430014, China

RECRUITING

CHN26-0

Wuhan, Hubei, 00000, China

RECRUITING

CHN34-0

Wuhan, Hubei, 430079, China

RECRUITING

CHN11-0

Changsha, Hunan, 410013, China

RECRUITING

CHN16-0

Xuzhou, Jiangsu, 221000, China

RECRUITING

CHN35-0

Shenyang, Liaoning, 110042, China

RECRUITING

CHN25-0

Xi'an, Shaanxi, 710061, China

RECRUITING

CHN04-0

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

CHN01-0

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

CHN24-0

Chengdu, Sichuan, 610041, China

RECRUITING

TWN01-0

Taipei, Taipei, 0, Taiwan

RECRUITING

TWN02-0

Taipei, Taipei, 23561, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Hepatocellular; Melanoma; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Jay Ma

CONTACT

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

Qiaoli Jiang

CONTACT

+86-15210642683; qiaoli.jiang@dualitybiologics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 1, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 6, 2026

Record last verified: 2025-08

Locations

CN (16); TW (2); US (15); AU (4)