Description:
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors
Title
- Brief Title: CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors
- Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
BA3021-001
- NCT ID:
NCT03504488
Conditions
- Solid Tumor
- Non Small Cell Lung Cancer
- Triple Negative Breast Cancer
- Soft Tissue Sarcoma
Interventions
| Drug | Synonyms | Arms |
|---|
| CAB-ROR2-ADC | BA3021 | BA3021 |
Purpose
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) in patients with
advanced solid tumors. This study will consist of a dose escalation phase and a dose
expansion phase.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BA3021 | Experimental | All patients will receive BA3021, CAB-ROR2-ADC. | |
Eligibility Criteria
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 received granulocyte colony stimulating factor (G-CSF) or
granulocyte/macrophage colony stimulating factor support 3 weeks prior to 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 Grade 2 or higher peripheral neuropathy.
- 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3021) |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Measured by frequency and severity of adverse events |
Secondary Outcome Measures
| Measure: | Pharmacokinetics; Cmax |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Maximum observed concentration of BA3021 |
| Measure: | Pharmacokinetics; AUC |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Area under the concentration versus time curve of BA3021 |
| Measure: | Immunogenicity of BA3021 |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Presence of anti-drug antibodies (ADA) |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | BioAtla, LLC |
Last Updated
May 2, 2019
