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

NCT06669975 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-04-25

No results posted yet for this study

Summary

This is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.

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.

Sponsors & Collaborators

  • AP Biosciences Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2026-12-01
Completion
2027-12-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06669975 on ClinicalTrials.gov