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Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 1 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 2 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 3 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 4 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 5 on Day 1 of each cycle Q3W

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

Enrolled Subjects will receive a single-dose of DB-1303 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 6 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1303 at Dose Level 7 on Day 1 of each cycle Q3W

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

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

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

DB-1303

Pertuzumab Injection

Britney Winterberger

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.

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.

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

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

Percentage of participants in Part 1 with DLTs

Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0

Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0

RP2D of DB-1303 based on the data collected during Part 1

Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0

Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0

The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks.

Area under the concentration-time curve from time 0 to infinity of DB-1303

Maximum observed plasma concentration (Cmax) of DB-1303

Data gathered from blood to determine Levels of anti-drug antibody (ADA) against DB 1303 in serum compared to baseline.

Proportion of participants who had a best response rating of CR or PR, or SD using RECIST V1.1.

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

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

The duration of time from participant receiving first dose of study drug to the last dose + 21 days

The percent change in the participant's target lesions from baseline to last study scan using RECIST V1.1

Time from subject receiving the first dose to disease progression or death by any cause

Time from subject receiving the first dose to death by any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of DB-1303 in Advanced/Metastatic Solid Tumors	NCT05150691	HER2-positive A...	DB-1303 Pertuzumab Inje... Ritonavir Itraconazole	18 Years -	DualityBio Inc.
A Study of DB-1303 in Advanced/Metastatic Solid Tumors	NCT05150691	HER2-positive A...	DB-1303 Pertuzumab Inje... Ritonavir Itraconazole	18 Years -	DualityBio Inc.

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