Myxofibrosarcoma, Undifferentiated Pleomorphic Sarcoma
Conditions
Keywords
late stage, stage 3, stage 4, cancer, undifferentiated pleomorphic sarcoma, myxofibrosarcoma
Brief summary
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
Detailed 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).
Interventions
BIOLOGICALCAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
BIOLOGICALPD-1 inhibitor
PD-1 inhibitor
Sponsors
BioAtla, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Safety Profile | Up to 24 months | Assess dose limiting toxicity as defined in the protocol |
| Phase 1 and 2: Safety Profile | Up to 24 months | Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs |
| Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1 | Up to 24 months | Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 and 2: Duration of response (DOR) | Up to 24 months | Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first |
| Phase 1 and 2: Progression-free survival (PFS) | Up to 24 months | Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first |
| Phase 1 and 2: Best overall response (BOR) | Up to 24 months | All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy |
| Phase 1: Pharmacokinetics | Up to 24 months | Plasma concentrations of ADC, total antibody and MMAE |
| Phase 1 and 2: Time to response (TTR) | Up to 24 months | Time from the first dose of investigational product until the first documentation of OR |
| Phase 1 and 2: Overall survival (OS) | Up to 24 months | Time from the first dose of BA3011 treatment until death due to any cause |
| Phase 1 and 2: Tumor size | Up to 24 months | Percent change from baseline in tumor size |
| Phase 1 and 2: Disease control rate (DCR) | Up to 24 months | Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks |
| Phase 1: Overall response rate (ORR) | Up to 24 months | Proportion of patients who achieve a confirmed CR or PR |
| Phase 1: Immunogenicity | Up to 24 months | The number and percentage of patients who develop detectable anti-drug antibodies (ADAs) |
Countries
Hong Kong, Taiwan, United States
Outcome results
None listed