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A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-08-03
Primary completion: 2025-12-30
Study completion finish: 2026-06-30
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05180799
Intervention or treatment
BIOLOGICAL: BA3071
BIOLOGICAL: Nivolumab
BIOLOGICAL: Pembrolizumab
DRUG: Pemetrexed (Alimta)
Conditions
- • NSCLC
- • Melanoma
Find a site
Closest Location:
Cancer Research South Australia
Research sites nearby
Select from list below to view details:
Cancer Research South Australia
Adelaide, South Australia, Australia
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
Albury, New South Wales, Australia
Cancer Care Foundation
Miranda, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: BA3071
| BIOLOGICAL: BA3071
|
EXPERIMENTAL: Combination Therapy
| BIOLOGICAL: BA3071
|
EXPERIMENTAL: Combination Therapy + Chemotherapy
| BIOLOGICAL: BA3071
|
EXPERIMENTAL: Neoadjuvant Combination Therapy + Chemotherapy
| BIOLOGICAL: BA3071
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Assess dose limiting toxicity as defined in the protocol | Phase 1: Safety Profile | Up to 24 months |
Assess maximum tolerated dose as defined in the protocol | Phase 1: Safety Profile | Up to 24 months |
Frequency and severity of AEs and/or SAEs | Phase 1 and 2: Safety Profile | Up to 24 months |
Confirmed overall response rate (ORR) per RECIST v1.1 | Phase 2: Efficacy | Up to 24 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Phase 1: Pharmacokinetics | Plasma concentrations of ADC | Up to 24 months |
Phase 1: Pharmacokinetics | Plasma concentrations of total antibody | Up to 24 months |
Phase 1: Pharmacokinetics | Plasma concentrations of MMAE | Up to 24 months |
Peak Plasma Concentration (Cmax) | Phase 1: Pharmacokinetics | Up to 24 months |
Area under the plasma concentration versus time curve (AUC) | Phase 1: Pharmacokinetics | Up to 24 months |
Confirmed best overall response (BOR) | Phase 1 and 2: Efficacy | Up to 24 months |
Confirmed overall response rate (ORR) | Phase 2: Efficacy | Up to 24 months |
Disease control rate (DCR) | Phase 1 and 2: Efficacy | Up to 24 months |
Time to response (TTR) | Phase 1 and 2: Efficacy | Up to 24 months |
Overall survival (OS) | Phase 1 and 2: Efficacy | Up to 24 months |
Percent change from baseline in target lesion sum of diameters. | Phase 1 and 2: Efficacy | Up to 24 months |
Duration of response (DOR) | Phase 1 and 2: Efficacy | Up to 24 months |
Progression-free survival (PFS) | Phase 1 and 2: Efficacy | Up to 24 months |
Frequently Asked Questions
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