Study of AMG 650 in Adult Participants With Advanced Solid Tumors
- Registration Number
- NCT04293094
- Lead Sponsor
- Volastra Therapeutics, Inc.
- Brief Summary
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Male and female ≥ 18 years old
- Triple Negative Breast Cancer participants only: Participant must have histologically or cytologically confirmed metastatic or locally recurrent estrogen receptor (ER)-negative (<1% by immunohistochemistry [IHC]), progesterone receptor (PR)-negative (<1% IHC) and human epidermal growth factor receptor 2 (Her2)-negative (either fluorescent in situ hybridisation [FISH] negative, 0 or 1+ by IHC, or IHC2+ and FISH negative per ASCO/CAP definition) breast cancer. Participant must be relapsed/refractory to at least one line of systemic chemotherapy in the metastatic setting (excluding neoadjuvant or adjuvant chemotherapies) or intolerant of existing therapy(ies) known to provide clinical benefit or have no other available treatment options. Prior exposure to an immune checkpoint inhibitor is allowed.
- Platinum-Resistant High Grade Serous Ovarian Cancer, primary peritoneal cancer and/or fallopian-tube cancer participants only: Participant must have histologically or cytologically confirmed diagnosis of metastatic or unresectable high grade serous ovarian cancer, with platinum-resistance defined as progression during or within 6 months of a platinum-containing regimen, with no other treatment option available. Prior exposure to platinum-resistant recurrence therapy is allowed.
- Serous Endometrial Cancer participants only (Dose Exploration only): Participant must have histologically or cytologically confirmed diagnosis of metastatic or recurrent serous endometrial cancer, and be relapsed/refractory to at least one line of systemic therapy in the metastatic/recurrent setting or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
- Participants with advanced or metastatic solid tumor with TP53MUT (Dose Exploration only, as assessed by local testing) that is unresectable and relapsed/refractory to at least one line of systemic chemotherapy or intolerant.
- TNBC participants only (Dose Expansion): Progressed on no more than 3 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with poly ADP ribose polymerase (PARP) inhibitor will be counted as one line of therapy.
- HGSOC participants only (Dose Expansion): Progressed on no more than 5 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with (PARP) inhibitor will be counted as one line of therapy. Induction followed by maintenance will be counted as one line of therapy.
- Untreated or symptomatic brain metastases and leptomeningeal disease (exception: benign asymptomatic tumors are permitted).
- Current primary CNS tumor, hematological malignancies or lymphoma.
- Uncontrolled pleural effusions(s), pericardial effusion, or ascites.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Expansion Phase Group 1: TNBC AMG 650 Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study. Dose Exploration Phase AMG 650 Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD. Dose Expansion Phase Group 2: HGSOC AMG 650 Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
- Primary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events (SAEs) Up to 24 months Number of Participants with Treatment-emergent Adverse Events (TEAEs) Up to 24 months Number of Participants with Treatment-related Adverse Events Up to 24 months Number of Participants with Dose Limiting Toxicities (DLTs) Up to 12 months Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement Up to 24 months Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests Up to 24 months Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement Up to 24 months
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) Up to 24 months Duration of Response (DOR) Up to 24 months Time to Progression (TTP) Up to 24 months Overall Survival (OS) Up to 24 months Time to Maximum Plasma Concentration (Tmax) of AMG 650 Up to 24 months Objective Response Rate (ORR) Up to 24 months Progression-free Survival (PFS) Up to 24 months Clinical Benefit Rate (CBR) Up to 24 months Maximum Plasma Concentration (Cmax) of AMG 650 Up to 24 months Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650 Up to 24 months
Trial Locations
- Locations (22)
The Angeles Clinic and Research Institute, West Los Angeles Office
🇺🇸Los Angeles, California, United States
Sarcoma Oncology Research Center LLC
🇺🇸Santa Monica, California, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Laura and Isaac Perlmutter Cancer Center at New York University Langone
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Texas Oncology - Baylor
🇺🇸Dallas, Texas, United States
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
IRCCS Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain