A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAP Biosciences Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy suitable.
Adult patients aged ≥ 18 years at the time of signing informed consent form (ICF).
Written informed consent by the patients or the patient's legally authorized representative prior to Screening.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.
Disqualifiers
Patients who have received concurrent antitumor treatment or investigational products within 28 days or 5 half-lives before the start of IP, whichever comes earlier. The antitumor treatments include chemotherapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin.
Patients who had received CD137-targeted therapeutics within 28 days or 5 half-lives before the start of IP, whichever comes earlier.
Patients who had major surgery within 28 days before the start of IP (excluding prior diagnostic biopsy).
Patients who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, and< Grade 2 sensory neuropathy.
Trial design
Treatments tested in this trial
- AP402 (Part 1 Dose esclation)
- AP402 (Part 2 Dose Expansion)
Treatment groups
85 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov