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AP402 in HER2-Positive Advanced Solid Tumors

NCT06669975Phase 2

Key facts

Status: Recruiting
Start: Apr 2025
Primary completion: Dec 2026
Countries: 1
Sponsor: AP Biosciences
Modality: Bispecific Antibodies

Drugs: AP402
Conditions: HER2-positive solid tumor

Overview

Phase 2, open-label trial of AP402 in HER2-positive solid tumor (2 arms), sponsored by AP Biosciences. Primary endpoints: Maximum Tolerated Dose, Adverse Events and 4 more. Started Apr 2025; status: recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Part 1 (Dose Escalation)
Dose escalation with 7 cohorts, accelerated then 3+3 design.
Part 2 (Dose Expansion)
Dose expansion at RP2D based on Simon's two-stage design.

Who it enrols

Adult patients with HER2-positive advanced solid tumors, adequate organ function, and no recent prior antitumor therapy or CD137-targeted therapeutics.

Endpoints

Primary

Maximum Tolerated Dose90 days after last dose
Adverse Events90 days after last dose
Maximum Plasma Concentration90 days after last dose
Time to Maximum Concentration90 days after last dose
Area Under Curve90 days after last dose

Secondary

Objective Response Rate30 days after last dose
Disease Control Rate90 days after last dose
Duration of Objective Response30 days after last dose
Duration of Disease Control30 days after last dose
Progression-Free SurvivalUp to 48 months
Overall SurvivalUp to 48 months
Time to Objective Response30 days after last dose
Time to Disease Control30 days after last dose

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