NSCLC, Melanoma
Conditions
Keywords
metastatic, cancer, First Line Melanoma, First Line NSCLC; 1L NSCLC, Treatment Refractory Melanomas, Nonsquamous Stage IV, Nonsquamous recurrent, 1L NSCLC, Systemic Treatment Naive, Nonsquamous Stage IIB, Nonsquamous Stage IIIA, KRAS, STK11, KEAP1, PD-L1 tumor proportion score (TPS) <1%
Brief summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
Detailed description
This is a multi-center, open-label study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071. Phase 2 is open and currently recruiting patients with: 1. Melanoma - 1L 2. nonsquamous or recurrent NSCLC (Type IIB, IIIA, IV) with single or any combination of the following mutations: KRAS mutation STK11 mutation KEAP1 mutation PD-L1 tumor proportion score (TPS) \<1%
Interventions
BIOLOGICALBA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
BIOLOGICALNivolumab
Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
BIOLOGICALPembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
pemetrexed with either cisplatin or carboplatin
Sponsors
BioAtla, Inc.
Study design
Allocation
NON_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 measurable disease. * Age ≥ 18 years * CLTA-4 blocking-antibody naïve * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS \<1% * Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)
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 well as 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 BA3071 administration. * 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 |
|---|---|---|
| Assess dose limiting toxicity as defined in the protocol | Up to 24 months | Phase 1: Safety Profile |
| Assess maximum tolerated dose as defined in the protocol | Up to 24 months | Phase 1: Safety Profile |
| Frequency and severity of AEs and/or SAEs | Up to 24 months | Phase 1 and 2: Safety Profile |
| Confirmed overall response rate (ORR) per RECIST v1.1 | Up to 24 months | Phase 2: Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Pharmacokinetics | Up to 24 months | Plasma concentrations of ADC |
| Peak Plasma Concentration (Cmax) | Up to 24 months | Phase 1: Pharmacokinetics |
| Area under the plasma concentration versus time curve (AUC) | Up to 24 months | Phase 1: Pharmacokinetics |
| Confirmed best overall response (BOR) | Up to 24 months | Phase 1 and 2: Efficacy |
| Confirmed overall response rate (ORR) | Up to 24 months | Phase 2: Efficacy |
| Disease control rate (DCR) | Up to 24 months | Phase 1 and 2: Efficacy |
| Time to response (TTR) | Up to 24 months | Phase 1 and 2: Efficacy |
| Overall survival (OS) | Up to 24 months | Phase 1 and 2: Efficacy |
| Percent change from baseline in target lesion sum of diameters. | Up to 24 months | Phase 1 and 2: Efficacy |
| Duration of response (DOR) | Up to 24 months | Phase 1 and 2: Efficacy |
| Progression-free survival (PFS) | Up to 24 months | Phase 1 and 2: Efficacy |
Countries
Australia, United States
Outcome results
None listed