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A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

PHASE1PHASE2RECRUITING

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

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Study details:

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  • At least 1 measurable lesion (per RECIST 1.1)
  • Provide signed informed consent
  • ECOG performance status (PS) of 0-1.
  • LVEF ≥ 50% by ECHO or MUGA
  • Adequate organ functions
  • Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
  • Life expectancy of ≥ 3 months.
  • Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.

    • Exclusion criteria

  • History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • History of myocardial infarction or unstable angina within 6 months before Day 1.
  • Average QTcF > 450 ms in males and > 470 ms in females
  • History of clinically significant lung diseases
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • HIV infection with AIDS defining illness or active viral hepatitis.
  • Clinically active brain metastases
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
  • A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  • Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-01-31

    Primary completion: 2026-04-01

    Study completion finish: 2027-10-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT05150691

    Intervention or treatment

    BIOLOGICAL: DB-1303/BNT323

    DRUG: Pertuzumab Injection

    DRUG: Ritonavir

    DRUG: Itraconazole

    Conditions

    • • HER2-positive Advanced Solid Tumor
    Image related to HER2-positive Advanced Solid Tumor

    • Condition: HER2-positive Advanced Solid Tumor

    • BIOLOGICAL: DB-1303/BNT323 and other drugs

    • Randwick, New South Wales, Australia and more

    • Sponsor: DualityBio Inc.

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Scientia Clinical Research LTD

    Research sites nearby

    Select from list below to view details:

    • Scientia Clinical Research LTD

      Randwick, New South Wales, Australia

    • Macquarie Clinical Trials Unit

      Sydney, New South Wales, Australia

    • Integrated Clinical Oncology Network Pty Ltd (Icon)

      South Brisbane, Queensland, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 1
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 2
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 3
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 4
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 5
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 1
    • Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 2
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 3
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 4
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 5
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 6
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Level 7
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 6
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 7
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 8
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 9
    • Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 10
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 11
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 12
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 13
    • Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV
    EXPERIMENTAL: DB-1303/BNT323 Dose Expansion 14
    • China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    BIOLOGICAL: DB-1303/BNT323
    • Administered IV

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0.Percentage of participants in Part 1 with DLTsup to 21 days after C1D1
    Phase 1: Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).Up to Safety Follow-Up visit, approximately 35 days post-treatment
    Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0Up to follow-up period, approximately 1 year post-treatment
    Phase 1: Maximum Tolerated Dose (MTD) of DB-1303MTD on the data collected during Part 1Up to Safety Follow-Up visit, approximately 35 days post-treatment
    Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303RP2D of DB-1303 based on the data collected during Part 1Up to Safety Follow-Up visit, approximately 35 days post-treatment
    Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) or Treatment Emergent Adverse Event of Special Interest include those \>/= G3 leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0, abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).Up to follow-up period, approximately 1 year post-treatment
    Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0Up to follow-up period, approximately 1 year post-treatment
    Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.The percentage of subjects who had a best response of CR or PR, for Part 2 only which was maintained ≥4 weeks.Up to follow-up period, approximately 1 year post-treatment
    Phase 2 (Dose Expansion 10 only): To evaluate the effect of ritonavir on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumorsMaximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Ritonavir)up to safety follow-up visit, approx. 35 days post-treatment
    Phase 2 (Dose Expansion 10 only): To evaluate the effect of itraconazole on DB-1303 and P1003 PK in subjects with HER2-expressing, HER2-amplified, or HER2-mutated advanced solid malignant tumors.Maximum observed plasms concentration (Cmax) and Area under the concentration-time curve from 0 to infinity of DB-1303 and P1003 (+/- Itraconazole)up to safety follow-up visit, approx. 35 days post-treatment

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Phase 1 & Phase 2: Pharmacokinetic-AUCArea under the concentration-time curve from time 0 to infinity of DB-1303Up to safety follow up visit, approx. 35 days post-treatment
    Phase 1 & Phase 2: Pharmacokinetic-CmaxMaximum observed plasma concentration (Cmax) of DB-1303Up to safety follow up visit, approx. 35 days post-treatment
    Phase 1 & Phase 2: Pharmacokinetic-TmaxTime to Cmax of DB-1303Up to safety follow up visit, approx. 35 days post-treatment
    Phase 1 & Phase 2: Pharmacokinetic-T1/2Terminal elimination half-lifeUp to safety follow up visit, approx. 35 days post-treatment
    Phase 1 & Phase 2: Pharmacokinetic-CtroughTrough concentration of DB-1303Up to safety follow up visit, approx. 35 days post-treatment
    Phase 1 & Phase 2: Pharmacodynamics-ADAData gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.Up to safety follow up visit, approx. 35 days post-treatment
    Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.Up to follow-up period, approximately 1 year post-treatment
    Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1The duration of time from date of first CR or PR to date of progressive disease or death due to any cause, whichever comes first using RECIST V1.1Up to follow-up period, approximately 1 year post-treatment
    Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1The duration of time when receiving the first dose of study drug to the first date that is evaluated as either CR or PR using RECIST V1.1Up to follow-up period, approximately 1 year post-treatment
    Phase 2: Time on TherapyThe duration of time from participant receiving first dose of study drug to the last dose + 21 daysUp to 21 days after the participant's last dose
    Phase 2: Percent change in target lesions as assessed by RECIST 1.1The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1Up to follow-up period, approximately 1 year post-treatment
    Phase 1 and 2 Cohort b only: Progression-Free SurvivalTime from subject receiving the first dose to disease progression or death by any causeUp to follow-up period, approximately 1 year post-treatment
    Phase 1 and 2 Cohort b only: Overall SurvivalTime from subject receiving the first dose to death by any causeUp to follow-up period, approximately 1 year post-treatment
    Phase I: Percentage of Objective Response Rate (ORR) as assessed by investigator based on RECIST 1.1The percentage of subjects who had a best response of CR or PRUp to follow-up period, approximately 1 year post-treatment
    Phase 2 Cohort b Only: Percentage of ORR as assessed by IRC and as assessed by investigator based on RECIST 1.1 for HER2-expressing subjects and in subjects with prior ICI treatmentThe percentage of subjects who had a best response of CR or PR, for Cohort 2b onlyUp to follow-up period, approximately 1 year post-treatment
    To evaluate the safety of DB-1303 with/without ritonavir or itraconazolePercentage of Participants with Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAE), TEAEs \>/= G3, or TEAEs leading to dose reduction, interruption or discontinuation, Adverse Events of Special Interest, (AESIs), abnormal vital signs, abnormal 12-lead ECGs, abnormal safety laboratory tests, abnormal ECOG PS, abnormal ECHO/MUGA (LVEF).Up to follow-up period, approximately 1 year post-treatment

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    References

    Clinical Trials Gov: A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

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