Solid TumorsPhase 2NCT06953089
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
A Phase 2 study testing DB-1311/BNT324, BNT327 and DB-1305/BNT325 in people with Solid Tumors, run by DualityBio Inc. at 37 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- DB-1311/BNT324, BNT327 and DB-1305/BNT325
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 37 sitesin 4 countries
- Study dates
- 18 Jul 2025to 30 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 CC with squamous cell, adenocarcinoma, or adenosquamous histology
- For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic/stage IV melanoma.
- For PROC patients (Part 1, Cohort 1A): 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 (Part 2 Arm 6 only): 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 (Part 2 Arm 7 only): Participants with advanced/unresectable metastatic PDAC without AGA who have progressed after only one prior line of standard systemic treatments (2L PDAC without AGA), or participants with AGA who have progressed on or after at least one and a maximum of two prior lines of standard systemic treatment (2L-3L PDAC with AGA).
- For breast cancer (Part 2 Arm 8 only):
- 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 (Part 2 Arm 9 only): Participants with advanced/unresectable mCRC without AGA who have progressed after only one prior line of standard systemic treatment (2L mCRC without AGA), or participants with AGA who have progressed on or after at least one and a maximum of two prior lines of standard systemic treatment (2L-3L mCRC with AGA).
- For mCRPC (Part 2 Arm 10 only): Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC
Who cannot join
- 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.
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- 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.
- Other protocol defined inclusion and exclusion criteria apply.
Trial locations and contacts
37 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 4 countries
China16 sites, 16 recruiting
- Recruiting
CHN02-0
Beijing, Beijing Municipality, 100021
- Recruiting
CHN13-0
Beijing, Beijing Municipality, 100032
- Recruiting
CHN23-0
Beijing, Beijing Municipality, 100142
- Recruiting
CHN11-0
Changsha, Hunan, 410013
- Recruiting
CHN24-0
Chengdu, Sichuan, 610041
- Recruiting
CHN17-0
Dongguan, Guangdong, 523000
- Recruiting
CHN06-0
Henan, Henan, 450008
- Recruiting
CHN04-0
Hubei, Hubei, 430014
- Recruiting
CHN04-0
Shanghai, Shanghai Municipality, 200032
- Recruiting
CHN01-0
Shanghai, Shanghai Municipality, 200120
- Recruiting
CHN35-0
Shenyang, Liaoning, 110042
- Recruiting
CHN26-0
Wuhan, Hubei, 00000
- Recruiting
CHN34-0
Wuhan, Hubei, 430079
- Recruiting
CHN25-0
Xi'an, Shaanxi, 710061
- Recruiting
CHN12-0
Xinxiang, Henan, 453100
- Recruiting
CHN16-0
Xuzhou, Jiangsu, 221000
United States15 sites, 15 recruiting
- Recruiting
USA13-0
Anderson, Texas, 46011
- Recruiting
USA10-0
Atlanta, Georgia, 30318
- Recruiting
USA11-0
Bethesda, Maryland, 20817
- Recruiting
USA03-0
Charleston, South Carolina, 29425
- Recruiting
USA08-0
Florida City, Florida, 99208
- Recruiting
USA12-0
Houston, Texas, 77030
- Recruiting
USA14-0
Lincoln, Nebraska, 68506
- Recruiting
USA06-0
Los Angeles, California, 90025
- Recruiting
USA16-0
Los Angeles, California, 90025
- Recruiting
USA04-0
New York, New York, 10032
- Recruiting
USA15-0
Portland, Oregon, 97239
- Recruiting
USA09-0
Puyallup, Washington, 98373
- Recruiting
USA07-0
Spokane, Washington, 99208
- Recruiting
USA05-0
Virginia Beach, Virginia, 22031
- Recruiting
USA01-0
Wheat Ridge, Colorado, 80033
Australia4 sites, 4 recruiting
- Recruiting
AUS05-0
Adelaide, South Australia, 5000
- Recruiting
AUS06-0
Benowa, Queensland, 4217
- Recruiting
AUS04-0
Birtinya, Queensland, 4575
- Recruiting
AUS07-0
North Sydney, New South Wales, 2060
Taiwan2 sites, 2 recruiting
- Recruiting
TWN01-0
Taipei, Taipei, 0
- Recruiting
TWN02-0
Taipei, Taipei, 23561
About this study
Official title: A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
Read the 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), 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.
- Conditions
- Solid Tumors
- Being tested
- DB-1311/BNT324, BNT327, DB-1305/BNT325
- 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)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Hepatocellular, Melanoma, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-1311/BNT324Drug
Administered I.V.
BNT327Drug
Administered I.V.
DB-1305/BNT325Drug
Administered I.V.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| 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. Receives: 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. Receives: 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 Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/ metastatic CC Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/metastatic melanoma Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with recurrent/metastatic HNSCC Receives: 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 Receives: Drug: DB-1311/BNT324; Drug: DB-1305/BNT325 |
| Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/metastatic PSOC Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/metastatic PDAC Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/metastatic breast cancer Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/metastatic CRC Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
| Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327 | Experimental | In participants with unresectable advanced/metastatic mCRPC Receives: Drug: DB-1311/BNT324; Drug: BNT327 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of participants with Dose Limiting Toxicities (DLTs).
Measured: 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)
Measured: up to follow up period, e.g. 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 by arm and dose level. (Arm 1-9).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per PCWG3-modified RECIST v1.1 as assessed by investigator) (Arm 10).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary outcomes (23)
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).
Measured: 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 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Measured: 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)
Measured: 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 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Measured: 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 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Measured: 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: Progression-free survival (PFS) per RECIST 1.1 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinum-resistant ovarian cancer (PROC).
Measured: From the time of initiation of the first dose of IMP to end of Part 1
Part 1 and 2: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with PROC.
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 2: Prostate-specific antigen (PSA)-based endpoints PSA50 response rate in participants with mCRPC (Arm 10).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 2: Prostate-specific antigen (PSA)-based endpoints PSA90 response rate in participants with mCRPC (Arm 10).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 2: Prostate-specific antigen (PSA)-based endpoints time to PSA progression in participants with mCRPC (Arm 10).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 2: Prostate-specific antigen (PSA)-based endpoints duration of PSA response in participants with mCRPC (Arm 10).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 2:Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)
Measured: 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: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Measured: 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: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Measured: 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 reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Measured: 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 reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Measured: 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: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Measured: 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: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Measured: 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: Terminal elimination half-life (t1/2) of DB-1311/BNT324 total ADC, total antibody and unconjugated P1021 in combination with BNT327.
Measured: 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: Terminal elimination half-life (t1/2) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Measured: 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: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline).
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 1 and Part 2: ADA incidence: the proportion of participants having treatment-emergent ADA.
Measured: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start18 Jul 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953089
- Sponsor's protocol ID
- DB-1311-201
- Other IDs
- 2025-523895-22-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06953089
- Acronym / sponsor ID
- DB-1311-201
- 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)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy | Experimental | Drug: DB-1311/BNT324, Drug: BNT327Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D (Recommended Phase 2 Dose) and RP2D-1 in target population. |
| Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy | Experimental | Drug: DB-1311/BNT324, Drug: BNT327Escalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population. |
| Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapy | Experimental | Drug: DB-1311/BNT324, Drug: DB-1305/BNT325Escalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population. |
| Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic HCC |
| Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/ metastatic CC |
| Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic melanoma |
| Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with recurrent/metastatic HNSCC |
| Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325 | Experimental | Drug: DB-1311/BNT324, Drug: DB-1305/BNT325In participants with advanced/unresectable metastatic NSCLC |
| Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic PSOC |
| Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic PDAC |
| Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic breast cancer |
| Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic CRC |
| Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327 | Experimental | Drug: DB-1311/BNT324, Drug: BNT327In participants with unresectable advanced/metastatic mCRPC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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,
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-1311/BNT324Administered I.V. | Drug | 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 10: RP2D of DB-1311/BNT324 + BNT327, 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, Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325, Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327, Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327, Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327, Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327, Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 |
| BNT327Administered I.V. | Drug | Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapy, Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapy, Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327, 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, Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327, Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327, Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327, Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327, Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327 |
| DB-1305/BNT325Administered I.V. | Drug | 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 |
Primary outcome
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: 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 by arm and dose level. (Arm 1-9).
Time frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per PCWG3-modified RECIST v1.1 as assessed by investigator) (Arm 10).
Time frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
23 secondary outcomes
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).
Time frame: 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 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Time frame: 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)
Time frame: 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 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Time frame: 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 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Time frame: 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: Progression-free survival (PFS) per RECIST 1.1 (Arm 1-9) and per PCWG3-modified RECIST v1.1 (Arm 10) based on the investigator's assessment.
Time frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinum-resistant ovarian cancer (PROC).
Time frame: From the time of initiation of the first dose of IMP to end of Part 1
Part 1 and 2: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with PROC.
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: Prostate-specific antigen (PSA)-based endpoints PSA50 response rate in participants with mCRPC (Arm 10).
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: Prostate-specific antigen (PSA)-based endpoints PSA90 response rate in participants with mCRPC (Arm 10).
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: Prostate-specific antigen (PSA)-based endpoints time to PSA progression in participants with mCRPC (Arm 10).
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: Prostate-specific antigen (PSA)-based endpoints duration of PSA response in participants with mCRPC (Arm 10).
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:Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)
Time frame: 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: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Time frame: 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: Maximum observed concentration (Cmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Time frame: 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 reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Time frame: 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 reach maximum observed concentration (Tmax) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Time frame: 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: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with BNT327.
Time frame: 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: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Time frame: 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: Terminal elimination half-life (t1/2) of DB-1311/BNT324 total ADC, total antibody and unconjugated P1021 in combination with BNT327.
Time frame: 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: Terminal elimination half-life (t1/2) of DB-1311/BNT324 ADC, total antibody and unconjugated P1021 in combination with DB-1305/BNT325.
Time frame: 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: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline).
Time frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 1 and Part 2: ADA incidence: the proportion of participants having treatment-emergent ADA.
Time frame: From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DB-1311/BNT324, BNT327 and DB-1305/BNT325 in people with Solid Tumors, run by DualityBio Inc. at 37 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in China, United States, Australia, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Ma (540-808-3925, jay.ma@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.