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
Qualifiers
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
Treatments tested in this trial
- APX-343A
- Pembrolizumab
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov