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

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DualityBio

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

HER2-positive Advanced Solid Tumor

Treatments

Drug: Itraconazole
Drug: Ritonavir
Drug: Pertuzumab Injection
Biological: DB-1303/BNT323

Study type

Interventional

Funder types

Industry

Identifiers

NCT05150691
DB-1303-O-1001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

766 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Additional Inclusion Criteria for Part 2 Expansion Group 9:

  1. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

766 participants in 21 patient groups

DB-1303/BNT323 Dose Level 1
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 2
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 3
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 4
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 5
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 1
Experimental group
Description:
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
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 2
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 3
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 4
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 5
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 6
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Level 7
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 6
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 7
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 8
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 9
Experimental group
Description:
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
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 10
Experimental group
Description:
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
Treatment:
Biological: DB-1303/BNT323
Drug: Ritonavir
Drug: Itraconazole
DB-1303/BNT323 Dose Expansion 11
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 12
Experimental group
Description:
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
Treatment:
Biological: DB-1303/BNT323
Drug: Pertuzumab Injection
DB-1303/BNT323 Dose Expansion 13
Experimental group
Description:
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
Treatment:
Biological: DB-1303/BNT323
DB-1303/BNT323 Dose Expansion 14
Experimental group
Description:
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
Treatment:
Biological: DB-1303/BNT323

Trial contacts and locations

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Central trial contact

Britney Winterberger

Data sourced from clinicaltrials.gov

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