A Phase 1A/B Study To Evaluate The Safety And Tolerability Of EBC-129 As A Single Agent And In Combination With Pembrolizumab In Advanced Solid Tumours

Primary Objective

This is a first-in-human study to learn more about the investigational drug EBC-129. This study will assess the safety and tolerability of EBC-129 when given alone and in combination with pembrolizumab in patients with advanced solid tumors.

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Description

This study is a prospective, open label study which is divided into 3 parts. Part A will be dose escalation segment to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of EBC-129 monotherapy. Part B will be dose escalation segment to identify the MTD and RP2D of EBC-129 in combination with pembrolizumab. Part C (dose expansion cohort) will be performed in an expanded cohort of patients with advanced solid malignancies at the RP2D of EBC-129 as a monotherapy identified in the dose escalation segment, Part A.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. Visit ClinicalTrials.gov to learn more about this study.
Locations

CTRC Inpatient
University of Colorado Hospital

Principal Investigator
Photograph of Robert Lentz

Robert Lentz

Study ID

Protocol Number: 23-0580

More information available at ClinicalTrials.gov: NCT05701527

Categories

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