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

Conditions

• HER2-positive Advanced Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DB-1303/BNT323 — BIOLOGICAL
  Administered IV
• Pertuzumab Injection — DRUG
  Administered IV
• Ritonavir — DRUG
  Administered oral
• Itraconazole — DRUG
  Administered oral

Study Details

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.

Key Dates

Start date

Jan 31, 2022

Status verified

Jan 2026

Primary completion

Apr 30, 2026

Completion

Oct 31, 2027

Study Design

Enrollment

796 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Experimental: DB-1303/BNT323 Dose Expansion 15
  China Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
• Experimental: DB-1303/BNT323 Dose Expansion 16
  Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
• Experimental: DB-1303/BNT323 Dose Expansion 17
  Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Primary Outcome Measure

Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. [ Time Frame: up to 21 days after C1D1 ]

Central Contacts

• Britney Winterberger
  +1-513-403-8568
  [email protected]

Locations (35)

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