Clinical trial NCT05180799: A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
Official title: A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: NSCLC
Melanoma
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%
Lead sponsor: BioAtla, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%

Eligibility criteria: 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.

Primary outcomes:
measure: Assess dose limiting toxicity as defined in the protocol
timeFrame: Up to 24 months
measure: Assess maximum tolerated dose as defined in the protocol
timeFrame: Up to 24 months
measure: Frequency and severity of AEs and/or SAEs
timeFrame: Up to 24 months
measure: Confirmed overall response rate (ORR) per RECIST v1.1
timeFrame: Up to 24 months
Secondary outcomes:
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Peak Plasma Concentration (Cmax)
timeFrame: Up to 24 months
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 24 months
measure: Confirmed best overall response (BOR)
timeFrame: Up to 24 months
measure: Confirmed overall response rate (ORR)
timeFrame: Up to 24 months
measure: Disease control rate (DCR)
timeFrame: Up to 24 months
measure: Time to response (TTR)
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Percent change from baseline in target lesion sum of diameters.
timeFrame: Up to 24 months
measure: Duration of response (DOR)
timeFrame: Up to 24 months
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Atlanta
country: United States
facility: Piedmont West
state: Georgia
city: Dyer
country: United States
facility: Northwest Cancer Centers
state: Indiana
city: Morristown
country: United States
facility: Morristown Medical Center/Atlantic Health System
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Albury
country: Australia
facility: Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
state: New South Wales
city: Miranda
country: Australia
facility: Cancer Care Foundation
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research South Australia
state: South Australia
Study officials:
References: