A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT05954312
- Lead Sponsor
- Vividion Therapeutics, Inc.
- Brief Summary
A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, in combination with docetaxel, and in combination with paclitaxel.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 (Dose Escalation): VVD-130037 Single Agent VVD-130037 Participants will receive ascending doses of VVD-130037, orally, once or twice daily in 21-day treatment cycles during Part 1. Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination Therapy VVD-130037 Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with docetaxel intravenous (IV) infusion administered once every 3 weeks in 21-day treatment cycles during Part 1. Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination Therapy Docetaxel Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with docetaxel intravenous (IV) infusion administered once every 3 weeks in 21-day treatment cycles during Part 1. Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination Therapy VVD-130037 Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 1. Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination Therapy Paclitaxel Participants will receive ascending doses of VVD-130037, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 1. Part 2 (Dose Expansion): VVD-130037 Single Agent VVD-130037 Participants will receive VVD-130037 at the recommended dose for expansion (RDE), orally, once or twice daily in 21-day treatment cycles during Part 2. Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination Therapy VVD-130037 Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with docetaxel IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2. Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination Therapy Docetaxel Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with docetaxel IV infusion administered once every 3 weeks in 21-day treatment cycles during Part 2. Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination Therapy VVD-130037 Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 2. Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination Therapy Paclitaxel Participants will receive VVD-130037 at the RDE, orally, once or twice daily along with paclitaxel IV infusion administered on Days 1, 8, and 15 of each 28-day treatment cycle during Part 2.
- Primary Outcome Measures
Name Time Method Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period Part 1: Single Agent and Docetaxel Combination Therapy Cohorts: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] and Part 1: Paclitaxel Combination Therapy Cohort: From Day 1 to Day 28 of Cycle 1 [cycle length=28 days] Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Part 2 (Dose Expansion): Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory Abnormalities Up to approximately 4 years
- Secondary Outcome Measures
Name Time Method Part 1 (Dose Escalation): Number of Participants With AEs, SAEs, and Clinical Laboratory Abnormalities Up to approximately 4 years Part 2 (Dose Expansion): Recommended Phase 2 Dose (RP2D) of VVD-130037 as a Single Agent and in Combination with Docetaxel and Paclitaxel Up to approximately 4 years The RP2D will be based on safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of VVD-130037 as single agent, and in combination with docetaxel and paclitaxel during Part 2.
Part 2 (Dose Expansion): Overall Response Rate (ORR) Up to approximately 4 years ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.
Part 2 (Dose Expansion): Duration of Response (DOR) Up to approximately 4 years DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.
Part 2 (Dose Expansion): Progression-free Survival (PFS) Up to approximately 4 years PFS is defined as the time from the date of randomization to the time of confirmed disease progression or death, whichever occurs first per RECIST version 1.1 by investigator assessment.
Part 2 (Dose Expansion): Disease Control Rate (DCR) Up to approximately 4 years DCR is defined as the percentage of participants achieving CR or PR, or stable disease (SD) per RECIST version 1.1 by investigator assessment.
Parts 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration-time Curve (AUC) of VVD-130037 Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel Combination Therapy Cohorts and cycle length=28 days for Paclitaxel Combination Therapy Cohorts) Parts 1 and 2 (Dose Escalation and Expansion): Maximum Observed Concentration (Cmax) of VVD-130037 Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel Combination Therapy Cohorts and cycle length=28 days for Paclitaxel Combination Therapy Cohorts) Parts 1 and 2 (Dose Escalation and Expansion): Apparent Terminal Half-life (T1/2) of VVD-130037 Parts 1 and 2: Predose and multiple timepoints post-dose from Cycle 1 Day 1 up to Cycle 5 Day 1 (cycle length=21 days for Single Agent and Docetaxel Combination Therapy Cohorts and cycle length=28 days for Paclitaxel Combination Therapy Cohorts) Parts 1 and 2 (Dose Escalation and Expansion): QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters Parts 1 and 2: Up to approximately 4 years Number of participants with changes in QT/QTc interval and other ECG parameters will be assessed.
Trial Locations
- Locations (25)
National Cancer Center
🇰🇷Goyang, South Korea
Gachon University Gil Medical Center
🇰🇷Incheon, South Korea
Seoul National University; Bundang Hospital
🇰🇷Seongnam, South Korea
Asan Medical Center
🇰🇷Seoul, South Korea
Samsung Medical Center
🇰🇷Seoul, South Korea
Seoul National University Hospital
🇰🇷Seoul, South Korea
Severance Hospital; Yonsei University Health System
🇰🇷Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, South Korea
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Scroll for more (15 remaining)National Cancer Center🇰🇷Goyang, South Korea