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NCT03425279 Clinical Trial

CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

Undifferentiated Pleomorphic Sarcoma Clinical Trial

Official title:
A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03425279
Other study ID # BA3011-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 15, 2018
Est. completion date December 2024

Study information
Verified date April 2024
Source BioAtla, Inc.
Contact BioAtla Medical Affairs
Phone 858-558-0708
Email medicalaffairs@bioatla.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

Description:

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors. Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024). Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Patients must have measurable disease. - Age = 12 years (Phase 2) - Adequate renal function - Adequate liver function - Adequate hematological function - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Life expectancy of at least three months. Exclusion Criteria: - Patients must not have clinically significant cardiac disease. - Patients must not have known non-controlled CNS metastasis. - Patients must not have a history of = Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. - Patients must not have had major surgery within 4 weeks before first BA3011 administration. - Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. - Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. - Patients must not be women who are pregnant or breast feeding.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
• PD-1 inhibitor
PD-1 inhibitor

Locations
Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Memorial Hospital Taoyuan
United States University of Colorado Aurora Colorado
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Northwestern University Chicago Illinois
United States The Christ Hospital Cincinnati Ohio
United States University Hospitals Seidman Cancer Center Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Mary Crowley Cancer Research Dallas Texas
United States Sarah Cannon Research Institute at Health One Denver Colorado
United States Duke Cancer Institute Durham North Carolina
United States MD Anderson Cancer Center Houston Texas
United States Comprehensive Cancer Center of Nevada Las Vegas Nevada
United States Children's Hospital Los Angeles Los Angeles California
United States Precision NextGen Oncology Los Angeles California
United States Tower Hematology Oncology Medical Group Los Angeles California
United States USC Norris Comprehensive Cancer Center Los Angeles California
United States Norton Cancer Institute Louisville Kentucky
United States Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin
United States Tennessee Oncology Nashville Tennessee
United States Vanderbilt Ingram Cancer Center Nashville Tennessee
United States Columbia University New York New York
United States Memorial Sloan Kettering New York New York
United States Abramson Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Washington University School of Medicine - Siteman Cancer Center Saint Louis Missouri
United States University of Utah - Huntsman Cancer Institute Salt Lake City Utah
United States UCSF Medical Center - Cancer Immunotherapy Clinic (CIC) San Francisco California
United States Seattle Cancer Care Alliance Seattle Washington
United States Moffitt Cancer Center Tampa Florida
United States The University of Arizona Cancer Center Tucson Arizona
United States Children's Research Institute Washington District of Columbia
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
BioAtla, Inc.

Countries where clinical trial is conducted

United States,  Hong Kong,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phase 1: Safety Profile Assess dose limiting toxicity as defined in the protocol Up to 24 months
Primary Phase 1: Safety Profile Assess maximum tolerated dose as defined in the protocol Up to 24 months
Primary Phase 1 and 2: Safety Profile Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs Up to 24 months
Primary Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1 Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 Up to 24 months
Secondary Phase 1: Pharmacokinetics Plasma concentrations of ADC, total antibody and MMAE Up to 24 months
Secondary Phase 1: Pharmacokinetics Peak Plasma Concentration (Cmax) Up to 24 months
Secondary Phase 1: Pharmacokinetics Area under the plasma concentration versus time curve (AUC) Up to 24 months
Secondary Phase 1: Overall response rate (ORR) Proportion of patients who achieve a confirmed CR or PR Up to 24 months
Secondary Phase 1: Immunogenicity The number and percentage of patients who develop detectable anti-drug antibodies (ADAs) Up to 24 months
Secondary Phase 1 and 2: Duration of response (DOR) Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first Up to 24 months
Secondary Phase 1 and 2: Progression-free survival (PFS) Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first Up to 24 months
Secondary Phase 1 and 2: Best overall response (BOR) All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy Up to 24 months
Secondary Phase 1 and 2: Disease control rate (DCR) Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) = 12 weeks Up to 24 months
Secondary Phase 1 and 2: Time to response (TTR) Time from the first dose of investigational product until the first documentation of OR Up to 24 months
Secondary Phase 1 and 2: Overall survival (OS) Time from the first dose of BA3011 treatment until death due to any cause Up to 24 months
Secondary Phase 1 and 2: Tumor size Percent change from baseline in tumor size Up to 24 months
See also
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Active, not recruiting NCT03307616 - Nivolumab With and Without Ipilimumab and Radiation Therapy in Treating Patients With Recurrent or Resectable Undifferentiated Pleomorphic Sarcoma or Dedifferentiated Liposarcoma Before Surgery Phase 2
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Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Active, not recruiting NCT03899805 - A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas Phase 2
Active, not recruiting NCT03752398 - A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) Phase 1
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Not yet recruiting NCT03946943 - Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma Phase 2
Recruiting NCT04008238 - Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients N/A
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Active, not recruiting NCT04242238 - Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas Phase 1
Completed NCT02584309 - Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Not yet recruiting NCT06277154 - MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma Phase 2
Active, not recruiting NCT03651375 - Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall Phase 2
Recruiting NCT06113809 - Palbociclib and Pembrolizumab in Undifferentiated Pleomorphic Sarcoma (UPS) Phase 1