DB-1311 antibody-drug conjugate (ADC) for Non-small cell lung cancer | Cervical cancer | Melanoma | Hepatocellular carcinoma | Ovarian cancer | Squamous cell carcinoma of head and neck

Inclusion criteria

• {"criterion_text":"- Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent\n- Are POCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial, starting at the time of giving informed consent and continuously until 8 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.\n- Are males who are fertile or if they are potentially fertile (i.e., are not surgically [e.g., have had a vasectomy] or congenitally sterile) and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their female sexual partners to practice a highly effective form of contraception during the trial, starting at the time of giving informed consent and continuously until 5 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.\n- Are potentially fertile males who are willing to refrain from sperm donation, starting at the time of giving informed consent and continuously until 5 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last.\n- Please see Section 5.3 of the protocol for additional Cohort/Arm-specific inclusion criteria.\n- At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.\n- Has a life expectancy of ≥ 3 months.\n- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (see Section 8.4.3 of the protocol for details).\n- Has adequate organ function within 7 days prior to enrollment/randomization, as defined in Section 5.3 of the protocol.\n- Has adequate treatment washout period prior to the first dose of trial treatment, as defined in Section 5.3 of the protocol. Previous effective treatment will not be discontinued due to study participation.\n- Is capable of comprehending trial procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the trial and the schedule of assessments.\n- Are POCBP (participant of childbearing potential) who have a negative serum beta-hCG pregnancy test.\n- Are POCBP who agree to practice a highly effective form of contraception and to require their male partners to use condoms starting at the time of giving informed consent and continuously until 8 months after the last dose of DB-1311 or DB-1305, or until 6 months after the last dose of BNT327, whichever occurs last."}

Exclusion criteria

• {"criterion_text":"- Prior treatment with B7H3 targeted therapy.\n- Has a medical, psychological, or social condition or substance abuse which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol-described requirements.\n- Is vulnerable individual as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. This includes all sponsor, trial site, or third party (e.g., CRO, vendor) personnel directly involved in the conduct of the trial and their family members or dependents, as well as all trial site personnel otherwise supervised by the investigator.\n- Please see Section 5.4 of the protocol for additional Cohort/Arm-specific exclusion criteria.\n- Prior treatment with antibody-drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).\n- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as “radical” intent), per investigator’s assessment.\n- 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, including conditions specified in Section 5.4 of the protocol.\n- Has uncontrolled or significant disease or disorder, or history of specific diseases and disorders, as detailed in Section 5.4 of the protocol.\n- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. Toxicities that have resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement hormones) are allowed, if not associated with increased risk of complications per investigator’s assessment.\n- Has a history of allergies, hypersensitivities, or intolerance to the trial treatments including any excipients thereof.\n- Has a history of another primary malignancy within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated or have a known additional malignancy that is progressing or requires treatment.\n- Use of any IMP within 28 days or five half-lives if known (whichever is longer) before administration of first dose of trial treatment or ongoing participation in the active treatment phase of another interventional clinical trial or prior randomization or treatment in a previous trial with the same IMPs as the current trial, regardless of treatment assignment."}

Primary endpoints

• {"endpoint_text":"- Part 1: Number of participants with Dose Limiting Toxicities (DLTs)","definition_or_measurement_approach":"Count of participants experiencing Dose Limiting Toxicities (DLTs) in Part 1."}
• {"endpoint_text":"- Part 1: Treatment emergent adverse events (TEAEs) and treatment emergent serious AE (TESAEs)","definition_or_measurement_approach":"Collection and reporting of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) as per protocol safety reporting."}
• {"endpoint_text":"- Part 2: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST v1.1 based on the investigator’s assessment).","definition_or_measurement_approach":"Proportion of participants with confirmed complete response (CR) or partial response (PR) as best overall response assessed by Investigator per RECIST v1.1."}
• {"endpoint_text":"- Part 2: Safety and tolerability: TEAEs and TESAEs","definition_or_measurement_approach":"Collection and reporting of TEAEs and TESAEs during Part 2 per protocol safety reporting."}

Secondary endpoints

• {"endpoint_text":"- Part 1: Efficacy evaluations: objective response rate (ORR), defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator’s assessment)","definition_or_measurement_approach":"ORR determined as proportion with confirmed CR or PR per RECIST v1.1 by Investigator."}
• {"endpoint_text":"- Part 1: Duration of response (DoR), disease-control rate (DCR), Time to Response (TTR), Progression Free Survival (PFS) will be determined from tumor assessments by Investigator per RECIST v1.1.","definition_or_measurement_approach":"DoR, DCR, TTR, and PFS determined from Investigator tumor assessments per RECIST v1.1."}
• {"endpoint_text":"- Part 1: Cancer antigen 125 (CA-125) response rate assessed per Gynecological Cancer Intergroup (GCIG) criteria in participants with platinumresistant ovarian cancer (PROC).","definition_or_measurement_approach":"CA-125 response rate assessed using GCIG criteria in PROC participants."}
• {"endpoint_text":"- Part 1: Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured from specified baseline to death from any cause."}
• {"endpoint_text":"- Part 1: PK parameters of DB-1311 antibody-drug conjugate (ADC), total antibody, and unconjugated P1021 in combination with BNT327 or in combination with DB-1305.","definition_or_measurement_approach":"Pharmacokinetic parameters for DB-1311 ADC, total antibody, and unconjugated P1021 measured from serial blood samples per PK assay and schedule."}
• {"endpoint_text":"- Part 1: Anti-drug antibody (ADA) prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.","definition_or_measurement_approach":"ADA prevalence and incidence assessed via validated immunogenicity assays at specified timepoints."}
• {"endpoint_text":"- Part 2: DoR, DCR, TTR, and PFS determined by Investigator as per RECIST v1.1","definition_or_measurement_approach":"DoR, DCR, TTR and PFS determined from Investigator RECIST v1.1 assessments."}
• {"endpoint_text":"- Part 2: Safety and tolerability: TEAEs and TESAEs","definition_or_measurement_approach":"Collection and reporting of TEAEs and TESAEs during Part 2 per protocol safety reporting."}
• {"endpoint_text":"- Part 2: OS","definition_or_measurement_approach":"Overall survival measured from specified baseline to death from any cause."}
• {"endpoint_text":"- Part 2: PK parameters of DB-1311 ADC, total anti-B7H3 antibody, and unconjugated P1021.","definition_or_measurement_approach":"PK parameters measured from serial blood sampling and analysis per validated assays."}
• {"endpoint_text":"- Part 2: ADA prevalence: the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline). ADA incidence: the proportion of participants having treatment-emergent ADA.","definition_or_measurement_approach":"ADA prevalence and incidence assessed via validated immunogenicity assays at specified timepoints."}

France

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

54

Number Of Sites

7

Number Of Participants

17

Germany

Earliest CTIS Part Ii Submission Date

04-05-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

8

Number Of Sites

2

Number Of Participants

15

Italy

Earliest CTIS Part Ii Submission Date

29-04-2026

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

13

Number Of Sites

8

Number Of Participants

25

Spain

Earliest CTIS Part Ii Submission Date

30-04-2026

Latest Decision Or Authorization Date

14-05-2026

Processing Time Days

14

Number Of Sites

5

Number Of Participants

26

Poland

Earliest CTIS Part Ii Submission Date

30-04-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

15

Number Of Sites

1

Number Of Participants

19

Primary sponsor

Full Name

Dualitybio Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaron (US) Clinical Services Inc.

Responsibilities

Pharmacovigilance

Name

Labcorp Development (Asia) Pte Ltd

Responsibilities

Bioanalysis testing and reporting of samples according to study protocol/plan and regulatory compliance

Name

CluePoints

Responsibilities

Data Surveillance

Name

Bioclinica Inc.

Responsibilities

Clinical adjudication

Name

Calyx China Co. Ltd.

Responsibilities

IMP management, Backfill and part 2 randomization

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Management, testing, and reporting of clinical trial samples in accordance with the executed Statement of Work (SOW), supporting study execution and regulatory compliance

Name

Guangzhou Burning Rock Dx Co. Ltd.

Responsibilities

Sample testing

Name

United-Power Pharma Tech Co. Ltd.

Responsibilities

Clinical Sample Analysis

Name

Parexel International Limited

Name

Novotech Laboratory Services (Shanghai) Co. Ltd.

Third parties

• {"country":"United States","full_name":"Pharmaron (US) Clinical Services Inc.","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Bioanalysis testing and reporting of samples according to study protocol/plan and regulatory compliance","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Data Surveillance","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Clinical adjudication","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"China","full_name":"Calyx China Co. Ltd.","duties_or_roles":"IMP management, Backfill and part 2 randomization","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Management, testing, and reporting of clinical trial samples in accordance with the executed Statement of Work (SOW), supporting study execution and regulatory compliance","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Guangzhou Burning Rock Dx Co. Ltd.","duties_or_roles":"Sample testing","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"United-Power Pharma Tech Co. Ltd.","duties_or_roles":"Clinical Sample Analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Parexel International Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Novotech Laboratory Services (Shanghai) Co. Ltd.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Developing and maintaining clinical trial software, ensuring data accuracy and compliance, managing customer and partner relationships","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"BNT327 PK and ADA sample testing","organisation_type":"Pharmaceutical company"}