Head and Neck Cancer, Metastatic Cancer, Metastatic Squamous Cell Carcinoma of the Head and Neck, Recurrent Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
Cancer
Brief summary
This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Interventions
BIOLOGICALOzuriftamab Vedotin
Conditionally active biologic anti-ROR2 antibody drug conjugate
BIOLOGICALPembrolizumab
PD-1 inhibitor
BIOLOGICALEvalstotug (BA3071)
Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
BIOLOGICALCetuximab
Epidermal growth factor receptor (EGFR) antagonist
Sponsors
BioAtla, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology). * Neoadjuvant/induction setting (Cohort N1): Patient with newly diagnosed Stage III SCCHN who are eligible for induction therapy with resectable tumors. No prior treatments, including surgery, radiation, or systemic treatment, for SCCHN are allowed. * Recurrent or metastatic setting: Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). * First-line - Combination Cohorts (C1 and C2): Patients must have NO prior systemic therapy administered in the locally recurrent or metastatic setting. Previous treatments with PD-1/L1 inhibitor or anti-CTLA-4 treatment are not allowed. * Second-line (Combination Cohort C3) and Second-line+ (Monotherapy Cohorts M1 and M2): Patients must have documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination. Patients must have measurable disease. * 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 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 known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. * Patients must not be women who are pregnant or are breast feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed Objective 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 |
| Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5 | Up to 24 months | Measured by frequency and severity of adverse events as assessed by CTCAE v5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best overall response (BOR) | Up to 24 months | All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy |
| 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. |
| 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 |
| Overall survival (OS) | Up to 24 months | Time from the first dose of BA3021 treatment until death due to any cause. |
| Complete response (CR) | Up to 24 months | Proportion of patients with a best overall response of confirmed CR |
| Time to response (TTR) | Up to 24 months | Time from the first dose of investigational product until the first documentation of OR. |
| 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. |
Countries
United States
Outcome results
None listed