A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAptabio Therapeutics, Inc.
About this trial
This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.
Willing and able to give informed consent and to comply with the requirements of the study.
Histologically or cytologically confirmed advanced solid tumor.
Life expectancy of at least 3 months in the judgment of the investigator.
Disqualifiers
Received any prior immunotherapy.
Received prior systemic anticancer therapy including investigational agents.
Received prior radiotherapy.
Received a live or live-attenuated vaccine .
Trial design
Design model
Parallel
Treatments tested in this trial
APX-343A
DrugOral administration twice daily
Pembrolizumab
Drugintravenous \[IV\]
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Part A : APX-343AExperimental treatment 1 intervention
Group B: Part BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To assess the safety and tolerability and to determine the MTD and/or RP2D of APX-343A monotherapy and in combination with pembrolizumab
Number and severity of TEAEs according to NCI-CTCAE v5.0
Time frame
From enrollment to 90 days after End Of TreatmentSecondary outcomes
1
Cmax of APX-343A
To characterize the PK of APX 343A monotherapy
Time frame
From enrollment to 3 weeks2
AUC of APX-343A
To characterize the PK of APX-343A monotherapy
Time frame
From enrollment to 3 weeks3
Tmax of APX-343A
To characterize the PK of APX-343A monotherapy
Time frame
From enrollment to 3 weeks4
t1/2 of APX-343A
To characterize the PK of APX-343A monotherapy
Time frame
From enrollment to 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aptabio Therapeutics, Inc.
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov