DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
NCT ID: NCT06953089
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
492 participants
INTERVENTIONAL
2025-07-18
2030-06-30
Brief Summary
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Detailed Description
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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) are eligible to participate in the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
DB-1311/BNT324
Administered I.V.
DB-1305/BNT325
Administered I.V.
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.
DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 and RP2D-1 of DB-1311/BNT324 + BNT327
In participants with recurrent/metastatic HNSCC
DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
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.
DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
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.
DB-1311/BNT324
Administered I.V.
DB-1305/BNT325
Administered I.V.
Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327
In participants with unresectable advanced/metastatic HCC
DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327
In participants with unresectable advanced/ metastatic CC
DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327
In participants with unresectable advanced/metastatic melanoma
DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
Interventions
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DB-1311/BNT324
Administered I.V.
BNT327
Administered I.V.
DB-1305/BNT325
Administered I.V.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
DualityBio Inc.
INDUSTRY
Responsible Party
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Locations
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USA06-0
Los Angeles, California, United States
USA16-0
Los Angeles, California, United States
USA01-0
Wheat Ridge, Colorado, United States
USA08-0
Florida City, Florida, United States
USA10-0
Atlanta, Georgia, United States
USA11-0
Bethesda, Maryland, United States
USA14-0
Lincoln, Nebraska, United States
USA04-0
New York, New York, United States
USA15-0
Portland, Oregon, United States
USA03-0
Charleston, South Carolina, United States
USA13-0
Anderson, Texas, United States
USA12-0
Houston, Texas, United States
USA05-0
Virginia Beach, Virginia, United States
USA09-0
Puyallup, Washington, United States
USA07-0
Spokane, Washington, United States
AUS07-0
North Sydney, New South Wales, Australia
AUS06-0
Benowa, Queensland, Australia
AUS04-0
Birtinya, Queensland, Australia
AUS05-0
Adelaide, South Australia, Australia
CHN02-0
Beijing, Beijing Municipality, China
CHN13-0
Beijing, Beijing Municipality, China
CHN23-0
Beijing, Beijing Municipality, China
CHN17-0
Dongguan, Guangdong, China
CHN06-0
Henan, Henan, China
CHN12-0
Xinxiang, Henan, China
CHN04-0
Hubei, Hubei, China
CHN26-0
Wuhan, Hubei, China
CHN34-0
Wuhan, Hubei, China
CHN11-0
Changsha, Hunan, China
CHN16-0
Xuzhou, Jiangsu, China
CHN35-0
Shenyang, Liaoning, China
CHN25-0
Xi'an, Shaanxi, China
CHN04-0
Shanghai, Shanghai Municipality, China
CHN01-0
Shanghai, Shanghai Municipality, China
CHN24-0
Chengdu, Sichuan, China
TWN01-0
Taipei, Taipei, Taiwan
TWN02-0
Taipei, Taipei, Taiwan
Countries
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Central Contacts
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Other Identifiers
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DB-1311-201
Identifier Type: -
Identifier Source: org_study_id
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