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A Study of DB-1303 in Advanced/Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05150691
Recruitment Status : Recruiting
First Posted : December 9, 2021
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
DualityBio Inc.

Tracking Information
First Submitted Date  ICMJE November 11, 2021
First Posted Date  ICMJE December 9, 2021
Last Update Posted Date October 19, 2023
Actual Study Start Date  ICMJE January 31, 2022
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2023)
  • Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. [ Time Frame: up to 21 days after C1D1 ]
    Percentage of participants in Part 1 with DLTs
  • Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) ot Treatment Emergent Adverse Event of Special Interest include those >/= G3 or leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
  • Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
  • Phase 1: Maximum Tolerated Dose (MTD) of DB-1303 [ Time Frame: 12 months ]
    MTD on the data collected during Part 1
  • Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303 [ Time Frame: 12 months ]
    RP2D of DB-1303 based on the data collected during Part 1
  • Phase 2: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) ot Treatment Emergent Adverse Event of Special Interest include those >/= G3 or leading to dose reduction, interruption or discontinuation as assessed by CTCAE v5.0 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
  • Phase 2: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
  • Phase 2: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2021)
  • Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. [ Time Frame: up to 21 days after C1D1 ]
    Percentage of participants in Part 1 with DLTs
  • Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
  • Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0
  • Phase 1: Maximum Tolerated Dose (MTD) of DB-1303 [ Time Frame: 12 months ]
    MTD on the data collected during Part 1
  • Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1303 [ Time Frame: 12 months ]
    RP2D of DB-1303 based on the data collected during Part 1
  • Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
  • Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
  • Phase 2a: Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1. [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2023)
  • Phase 1 & Phase 2: Pharmacokinetic-AUC [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Area under the concentration-time curve from time 0 to infinity of DB-1303
  • Phase 1 & Phase 2: Pharmacokinetic-Cmax [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Maximum observed plasma concentration (Cmax) of DB-1303
  • Phase 1 & Phase 2: Pharmacokinetic-Tmax [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Time to Cmax of DB-1303
  • Phase 1 & Phase 2: Pharmacokinetic-T1/2 [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Terminal elimination half-life
  • Phase 1 & Phase 2: Pharmacokinetic-Ctrough [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Trough concentration of DB-1303
  • Phase 1 & Phase 2: Pharmacodynamics-ADA [ Time Frame: Before infusion on C1D1, C1D15, Before infusion on day 1 of C2, C4, C6, C8, C10 and every 4 cycles until end of treatment, EOT visit, Safety FU Visit, and 60 and 90 days after last dose (if possible) ]
    Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.
  • Phase 1 & 2: Disease Control Rate (DCR) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.
  • Phase 1 & 2: Duration of Response (DoR) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The 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 V1.1
  • Phase 1 & 2: Time to Response (TTR) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The 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 V1.1
  • Phase 2: Time on Therapy [ Time Frame: Up to 21 days after the participant's last dose ]
    The duration of time from participant receiving first dose of study drug to the last dose + 21 days
  • Phase 2: Percent change in target lesions as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1
  • Phase 2 Cohort b only: Progression-Free Survival [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Time from subject receiving the first dose to disease progression or death by any cause
  • Phase 2 Cohort b only: Overall Survival [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Time from subject receiving the first dose to death by any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2021)
  • Phase 1 & Phase 2a: Pharmacokinetic-AUC [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Area under the concentration-time curve from time 0 to infinity of DB-1303
  • Phase 1 & Phase 2a: Pharmacokinetic-Cmax [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Maximum observed plasma concentration (Cmax) of DB-1303
  • Phase 1 & Phase 2a: Pharmacokinetic-Tmax [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Time to Cmax of DB-1303
  • Phase 1 & Phase 2a: Pharmacokinetic-T1/2 [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Terminal elimination half-life
  • Phase 1 & Phase 2a: Pharmacokinetic-Ctrough [ Time Frame: Pre-Dose, 30 minutes post end of infusion, 4 hours, 8 hours, 24 hours, 72 hours, 7 days, 14 days post start of infusion at Cycle 1 and Cycle 3. Pre-dose and within 30 minutes post end of infusion up to Cycle 8, End of Treatment and Safety Follow-up Visit ]
    Trough concentration of DB-1303
  • Phase 1 & Phase 2a: Pharmacodynamics-ADA [ Time Frame: Before infusion on C1D1, C1D15, Before infusion on day 1 of C2, C4, C6, C8, C10 and every 4 cycles until end of treatment, EOT visit, Safety FU Visit, and 60 and 90 days after last dose (if possible) ]
    Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.
  • Phase 2a: Disease Control Rate (DCR) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.
  • Phase 2a: Duration of Response (DoR) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The 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 V1.1
  • Phase 2a: Time to Response (TTR) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The 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 V1.1
  • Phase 2a: Progression Free Survival (PFS) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The duration of time from date of receiving first dose of study drug to date of progressive disease or death due to any cause, whichever comes first using RECIST V1.1
  • Part 2: Overall Survival (OS) as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    Time from date of receiving first dose of study drug to death due to any cause using RECIST V1.1
  • Part 2: Time on Therapy [ Time Frame: Up to 21 days after the participant's last dose ]
    The duration of time from participant receiving first dose of study drug to the last dose + 21 days
  • Phase 2a: Percent change in target lesions as assessed by RECIST 1.1 [ Time Frame: Up to follow-up period, approximately 1 year post-treatment ]
    The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of DB-1303 in Advanced/Metastatic Solid Tumors
Official Title  ICMJE A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients With Advanced/Metastatic Solid Tumors
Brief Summary This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.
Detailed Description This is a multicenter, non-randomized, 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HER2-positive Advanced Solid Tumor
Intervention  ICMJE
  • Biological: DB-1303
    Administered IV
  • Drug: Pertuzumab Injection
    Administered IV
  • Drug: Ritonavir
    Administered oral
  • Drug: Itraconazole
    Administered oral
Study Arms  ICMJE
  • Experimental: DB-1303 Dose Level 1
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 1 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Level 2
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 2 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Level 3
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 3 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Level 4
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 4 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Level 5
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 5 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 1
    Enrolled Subjects will be randomized to receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 2
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 3
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 4
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 5
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Level 6
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 6 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Level 7
    Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 7 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 6
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 7
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 8
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 9
    Enrolled Subjects will be randomized to receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 10
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir and itraconazole to assess the DDI potential
    Interventions:
    • Biological: DB-1303
    • Drug: Ritonavir
    • Drug: Itraconazole
  • Experimental: DB-1303 Dose Expansion 11
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
  • Experimental: DB-1303 Dose Expansion 12
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
    Interventions:
    • Biological: DB-1303
    • Drug: Pertuzumab Injection
  • Experimental: DB-1303 Dose Expansion 13
    Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
    Intervention: Biological: DB-1303
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2023)		 631
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2021)		 140
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Britney Winterberger +1-513-403-8568 britney.winterberger@tigermedgrp.com
Listed Location Countries  ICMJE Australia,   China,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05150691
Other Study ID Numbers  ICMJE DB-1303-O-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party DualityBio Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE DualityBio Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account DualityBio Inc.
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP