Advanced Adenocarcinoma
Conditions
Keywords
Advanced, Metastatic, Cancer
Brief summary
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
Detailed description
This is a multi-center, open-label, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3182 in patients with advanced adenocarcinoma.
Interventions
DRUGBA3182
Conditionally active biologic (CAB)-bispecific T-cell engager antibody construct targeting EpCAM
Sponsors
BioAtla, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma * 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.
Exclusion criteria
* Patients must not have clinically significant cardiac disease. * Patients must not have known non-controlled CNS metastasis. * Patients must not have active autoimmune disease or a documented history of autoimmune disease. * 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 incomplete recovery from the effects of major surgery or significant traumatic injury before the first dose of study treatment. * 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 |
|---|---|---|
| Part 1: Assess dose limiting toxicity as defined in the protocol | Up to 24 months | Phase 1 Part 1: Safety Profile of BA3182 |
| Part 1: Assess maximum tolerated dose as defined in the protocol | Up to 24 months | Phase 1 Part 1: Safety Profile of BA3182 |
| Part 2: Confirmed overall response rate (ORR) per RECIST v1.1 | Up to 24 months | Phase 1 Part 2: Antitumor activity of BA3182 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed progression-free survival (PFS) | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
| Confirmed disease control rate (DCR) | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
| Confirmed time to response (TTR) | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
| Confirmed overall survival (OS) | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
| Confirmed overall response rate (ORR) per RECIST v1.1 | Up to 24 months | Phase 1 Part 1: Antitumor activity of BA3182 |
| Area under the plasma concentration versus time curve (AUC) | Up to 24 months | Phase 1: Pharmacokinetics of BA3182 |
| Peak Plasma Concentration (Cmax) Phase 1: Pharmacokinetics | Up to 24 months | Phase 1: Pharmacokinetics of BA3182 |
| Incidence of anti-drug antibody (ADAs) to BA3182 Phase 1: Pharmacokinetics Phase 1: Immunogenicity | Up to 24 months | Phase 1: Immunogenicity of BA3182 |
| Incidence of neutralizing antibodies (nAbs) to BA3182. | Up to 24 months | Phase 1: Immunogenicity of BA3182 |
| Confirmed percent change from baseline in target lesion sum of diameters. | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
| Confirmed best overall response best overall response (BOR) | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
| Confirmed duration of response (DOR) | Up to 24 months | Phase 1: Antitumor activity of BA3182 |
Countries
United States
Contacts
Primary ContactBioAtla Medical Affairs
Outcome results
None listed