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Trial record 1 of 1 for:    DB 1303
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A Study of DB-1303 in Advanced/Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05150691
Recruitment Status : Not yet recruiting
First Posted : December 9, 2021
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
DualityBio Inc.

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.

Condition or disease Intervention/treatment Phase
HER2-positive Advanced Solid Tumor Biological: DB-1303 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Multicenter, Open-Label, Non-Randomized First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients With Advanced/Metastatic Solid Tumors
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : October 2025


Arm Intervention/treatment
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
Biological: DB-1303
Administered IV

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
Biological: DB-1303
Administered IV

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
Biological: DB-1303
Administered IV

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
Biological: DB-1303
Administered IV

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
Biological: DB-1303
Administered IV

Experimental: DB-1303 Dose Expansion 1
Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Biological: DB-1303
Administered IV

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
Biological: DB-1303
Administered IV

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
Biological: DB-1303
Administered IV




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Phase 1: Maximum Tolerated Dose (MTD) of DB-1303 [ Time Frame: 12 months ]
    MTD on the data collected during Part 1

  5. 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

  6. 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

  7. 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

  8. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a pathologically documented HER2-expressing 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.
  • Part 2 only: Prior treatment with HER2 ADC agents except T-DM1, RC48-ADC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05150691


Contacts
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Contact: Britney Winterberger +1-513-403-8568 britney.winterberger@tigermedgrp.com

Locations
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United States, California
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
DualityBio Inc.
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Responsible Party: DualityBio Inc.
ClinicalTrials.gov Identifier: NCT05150691    
Other Study ID Numbers: DB-1303-O-1001
First Posted: December 9, 2021    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DualityBio Inc.:
HER2
HER2-positive
HER2-positive Breast Cancer
HER2-positive Gastric Cancer
HER2-positive Endometrial Cancer
HER2-positive Biliary Tract Cancer
HER2-positive Advanced Solid Tumor
HER2 low
HER2 high
metastatic cancer
HER2-positive GEJ
Uterine serous papillary carcinoma
USPC
recurrent cancer
carcinoma
neoplasms
breast neoplasms
gastrointestinal neoplasms
endometrial neoplasms
biliary tract neoplasms
Antineoplastic Agents, Biological
stomach cancer
bile duct cancer
Cholangiocarcinoma
liver cancer
liver neoplasms
Additional relevant MeSH terms:
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Neoplasms