Clinical Trials in Australia / NCT05180799
Active, not recruiting
Phase 1/2
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
NCT05180799 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
NSCLCMelanoma
Investigational drug(s) / intervention(s)
BA3071: Conditionally active biologic (CAB) antibody that binds to CTLA-4
Nivolumab: Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
Pembrolizumab: Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Pemetrexed (Alimta): pemetrexed with either cisplatin or carboplatin
Study summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
Eligibility
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 outcome measure(s)
- 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
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| The Angeles Clinic and Research Institute | Los Angeles | California | |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | |
| Piedmont West | Atlanta | Georgia | |
| Northwest Cancer Centers | Dyer | Indiana | |
| Morristown Medical Center/Atlantic Health System | Morristown | New Jersey | |
| Icahn School of Medicine at Mt. Sinai | New York | New York | |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | |
| Providence Cancer Institute | Portland | Oregon | |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | |
| Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre | Albury | New South Wales | |
| Cancer Care Foundation | Miranda | New South Wales | |
| Cancer Research South Australia | Adelaide | South Australia |
Other trials for the same condition
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
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Intratumoral N17350 in Advanced Solid Tumors
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A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05180799 on ClinicalTrials.gov ↗ ← All trials in Australia