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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
AP402 (Part 1 Dose esclation)
DrugDose 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.
AP402 (Part 2 Dose Expansion)
DrugAfter 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.
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: Part 1 (Dose escalation)Experimental treatment 1 intervention
Group B: Part 2 (Dose Expansion)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Estimate of Maximum tolerated dose (MTD)
This will be based on dose limiting toxicities (DLT) observed during the DLT evaluation period.
Time frame
Baseline to 90 days after the last dose2
Number of participants with Adverse events (AEs) and Serious Adverse events (SAE) as assessed by CTCAE V5
Time frame
Baseline to 90 days after the last dose3
To evaluate R2PD based on PK parameters- Cmax (Maximum plasma concentration)
Time frame
Baseline to 90 days after the last dose4
To evaluate R2PD based on PK parameters- Tmax (time for maximum concentration)
Time frame
Baseline to 90 days after the last doseSecondary outcomes
1
To evaluate objective response rate (ORR)
The proportion of patients whose best overall response (BOR) is either confirmed complete responses (CR) or confirmed partial responses (PR).
Time frame
Baseline to 30 days after the last dose2
Number of patients with disease Control Rate (DCR)
The proportion of patients whose best overall response of confirmed CR, confirmed PR, or (confirmed) stable disease (SD) that was assessed at least 4 weeks (28 days) following the initiation of AP402
Time frame
Baseline to 90 days after the last dose3
Number of patients with changes in duration of objective response (DOOR)
The time from first documented objective response (confirmed CR or confirmed PR) until the earlier of disease progression or death from any cause, whichever occurs first.
Time frame
Baseline to 30 days after the last dose4
Duration of disease control response (DODC):
The time from first documented disease control response (confirmed CR, confirmed PR, or confirmed SD) until the earlier of disease progression or death from any cause, whichever occurs first. This will only be applicable for patients who have a confirmed best overall response of CR, PR, or SD. Patients without the events (progressive disease or death) will be censored at the date of their last tumor assessment.
Time frame
Baseline to 30 days after the last doseSponsors and contacts
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Source ClinicalTrials.gov