Head and Neck Cancer, Melanoma, Non Small Cell Lung Cancer, Triple Negative Breast Cancer
Conditions
Brief summary
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC 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 BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors. This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.
Interventions
BIOLOGICALCAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
BIOLOGICALPD-1 inhibitor
PD-1 inhibitor
Sponsors
BioAtla, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy. * Patients must have measurable disease. * For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS) * Age ≥ 18 years. * 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 wellas 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 BA3021 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 |
| Phase 2: Confirmed Objective Response Rate (ORR) | Up to 24 months | Proportion of patients who achieve a confirmed CR or PR |
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 (OR) | 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 BA3021 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: Confirmed Objective 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
Greece, Hong Kong, Poland, Spain, Taiwan, United States
Outcome results
None listed