Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors
- Conditions
- HER2-positive Breast CancerHER-2 Protein OverexpressionHER-2 Gene AmplificationHER2 Gene Mutation
- Interventions
- Registration Number
- NCT05511844
- Lead Sponsor
- Orum Therapeutics USA, Inc.
- Brief Summary
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Dose Escalation ORM-5029 All participants receive ORM-5029 in escalating dose cohorts in Part 1 Dose Escalation and at the Expansion Dose Level (EDL) in Part 2 Dose Expansion. Part 2 Dose Expansion ORM-5029 All participants receive ORM-5029 at dose levels with pharmacodynamic activity or efficacy signals (Expansion Cohort A) or at the Expansion Dose Level (EDL) (Expansion Cohorts B and C).
- Primary Outcome Measures
Name Time Method Determination of Maximum Tolerated Dose (MTD) and Expansion Dose Level (EDL) [Dose Escalation Only] DLT assessment period: At the end of Cycle 1 (each cycle is 21 or 28 days); Approximately 18 months for MTD and EDL Identify the Dose-limiting Toxicities (DLTs) for each dose level tested and determine the MTD and EDL for ORM-5029
Incidence of Adverse Events (AEs) Every cycle (each cycle is 21 or 28 days) until study discontinuation; Approximately 30 months Evaluate the safety and tolerability of ORM-5029 by identifying the treatment-emergent adverse events (TEAEs)
Define the Objective Response Rate (ORR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only] Approximately 30 months ORR is defined as the percentage of subjects with Partial Response (PR) or Complete Response (CR)
Define the Duration of Response (DOR) of ORM-5029 based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [Dose Expansion Only] Approximately 30 months DOR is defined as the length of time from the date of the first documented response (PR or CR) until the date of first documented progression or date of death from any cause, whichever came first
- Secondary Outcome Measures
Name Time Method Access pharmacokinetic (PK) parameters including terminal rate consent and terminal elimination half-life (t1/2) Serial PK collections at Baseline, Days 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days) Assess pharmacokinetic (PK) parameters including area under the concentration versus time curve from time 0 hours to the last quantifiable concentration (AUC0-last) and from time 0 hours to infinity (AUC0-inf) Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days) Assess maximum plasma and serum drug concentration (Cmax) Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days) Define time to Cmax (Tmax) Serial PK collections at on Days 1, 2, 4, 8 and 15 of Cycle 1 and Day 1 of Cycle 3 (Pre-dose and at multiple timepoints [up to 6 hours]; each cycle is 21 or 28 days) Define Clinical Benefit Rate (CBR) of ORM-5029 based on RECIST 1.1 Approximately 30 months CBR is defined as CR + PR + stable disease (SD) up to 4 months
Define Time to Response (TTR) of ORM-5029 based on RECIST 1.1 Approximately 30 months TTR is defined as the length of time from baseline until the date of first documented response (PR or CR)
Define Duration of Response (DOR) of ORM-5029 based on RECIST 1.1 [Dose Escalation Only] Approximately 30 months DOR is defined as the length of time from the date of the first documented response (PR or CR) until the date of first documented progression or date of death from any cause, whichever came first
Assess Progression-free survival (PFS) of ORM-5029 based on RECIST 1.1 Approximately 30 months PFS is defined as the length of time from baseline until the date of first documented progression or date of death from any cause, whichever came first
Assess overall survival (OS) Following study discontinuation until withdrawal for any reason or death; Approximately 30 months Incidence of anti-drug antibody (ADA) against ORM-5029 Sample collection at Baseline, Day 1 of every Cycle until study discontinuation (each cycle is 21 or 28 days); Approximately 30 months
Trial Locations
- Locations (11)
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Weill Cornell Medicine-New York
🇺🇸New York, New York, United States
Sarah Cannon Research Institute at Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States
NEXT Oncology - Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States