Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 2

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

NCT ID: NCT06953089Sponsor: DualityBio Inc.Last updated: 2026-05-22

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

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) or 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.

Arms & interventions

  • DrugDB-1311/BNT324

    Administered I.V.

  • DrugBNT327

    Administered I.V.

  • DrugDB-1305/BNT325

    Administered I.V.

Outcome measures

Primary

  • 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

Secondary

  • 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 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 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 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 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: 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: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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (15)

USA06-0

Los Angeles, California, 90025

Recruiting

USA16-0

Los Angeles, California, 90025

Recruiting

USA01-0

Wheat Ridge, Colorado, 80033

Recruiting

USA08-0

Florida City, Florida, 99208

Recruiting

USA10-0

Atlanta, Georgia, 30318

Recruiting

USA11-0

Bethesda, Maryland, 20817

Recruiting

USA14-0

Lincoln, Nebraska, 68506

Recruiting

USA04-0

New York, New York, 10032

Recruiting

USA15-0

Portland, Oregon, 97239

Recruiting

USA03-0

Charleston, South Carolina, 29425

Recruiting

USA13-0

Anderson, Texas, 46011

Recruiting

USA12-0

Houston, Texas, 77030

Recruiting

USA05-0

Virginia Beach, Virginia, 22031

Recruiting

USA09-0

Puyallup, Washington, 98373

Recruiting

USA07-0

Spokane, Washington, 99208

Recruiting