A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

April 22, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2027

Conditions
Advanced Solid Tumor
Interventions
DRUG

AP402 (Part 1 Dose esclation)

Dose escalation will consist of 7 cohorts where an Intraveous infusion of AP402 will be administered once every 2 weeks to determine the maximum tolerated dose (MTD) (ie, the highest safe dose administered to patients) and the recommended phase 2 dose (RP2D) of AP402.

DRUG

AP402 (Part 2 Dose Expansion)

After the MTD and/or RP2D are determined by the SRC, additional patients will be enrolled in Phase 2 dose expansion and will be treated with AP402 at that dose.

Trial Locations (3)

2109

NOT_YET_RECRUITING

Macquarie University Clinical Trials Unit, Macquarie

5043

NOT_YET_RECRUITING

Flinders Medical Centre, Bedford Park

6009

RECRUITING

Linear Clinical Research, Perth

Sponsors
All Listed Sponsors
lead

AP Biosciences Inc.

INDUSTRY

NCT06669975 - A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors | Biotech Hunter | Biotech Hunter