Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
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|ClinicalTrials.gov Identifier: NCT03425279|
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : October 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Non Small Cell Lung Cancer Melanoma Sarcoma Sarcoma, Ewing Osteosarcoma Leiomyosarcoma Synovial Sarcoma Liposarcoma Soft Tissue Sarcoma Bone Sarcoma Refractory Sarcoma||Biological: CAB-AXL-ADC Biological: PD-1 inhibitor||Phase 1 Phase 2|
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors in Phase 1 and BA3011 alone and in combination with a PD-1 inhibitor in Phase 2.
Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling ACC patients only).
Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/ 2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-AXL-ADC, Alone and in Combination With a PD-1 Inhibitor in Adult Patients With Advanced Solid Tumors (Phase 1) and Adult and Adolescent Patients With Advanced, Refractory Sarcoma (Phase 2)|
|Actual Study Start Date :||February 15, 2018|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
Conditionally active biologic anti-AXL antibody drug conjugate
Experimental: Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
Conditionally active biologic anti-AXL antibody drug conjugate
Biological: PD-1 inhibitor
- Phase 1: Safety Profile [ Time Frame: Up to 24 months ]Assess dose limiting toxicity as defined in the protocol
- Phase 1: Safety Profile [ Time Frame: Up to 24 months ]Assess maximum tolerated dose as defined in the protocol
- Phase 1 and 2: Safety Profile [ Time Frame: Up to 24 months ]Frequency and severity of AEs and/or SAEs
- Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1 [ Time Frame: Up to 24 months ]Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
- Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]Plasma concentrations of ADC, total antibody and MMAE
- Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]Peak Plasma Concentration (Cmax)
- Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]Area under the plasma concentration versus time curve (AUC)
- Phase 1: Overall response rate (ORR) [ Time Frame: Up to 24 months ]Proportion of patients who achieve a confirmed CR or PR
- Phase 1: Immunogenicity [ Time Frame: Up to 24 months ]The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
- Phase 1 and 2: Duration of response (DOR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 24 months ]All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
- Phase 1 and 2: Disease control rate (DCR) [ Time Frame: 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 and 2: Time to response (TTR) [ Time Frame: 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) [ Time Frame: Up to 24 months ]Time from the first dose of BA3011 treatment until death due to any cause
- Phase 1 and 2: Tumor size [ Time Frame: Up to 24 months ]Percent change from baseline in tumor size
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425279
|Contact: Hazel Buncabemail@example.com|
|Contact: Ji Hwan Leefirstname.lastname@example.org|
|Responsible Party:||BioAtla, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 7, 2018 Key Record Dates|
|Last Update Posted:||October 6, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological