To hear about similar clinical trials, please enter your email below
Trial Title:
Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors
NCT ID:
NCT06596915
Condition:
Non-Small Cell Lung Cancer
Pancreatic Adenocarcinoma
Breast Cancer
Melanoma
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BA1302
Description:
BA1302 administered intravenously
Arm group label:
BA1302
Summary:
This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the
safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in
patients with advanced solid malignancies. The study includes a dose-escalation phase
(Part A) and a dose-expansion phase (Part B).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Metastatic or unresectable solid malignancy that is histologically or
cytologically confirmed. Patients who have progressed on or after standard
therapy, or are intolerant of standard therapy, or have no appropriate standard
therapy available.
1. Part A: Advanced malignant solid tumors;
2. Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell
lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.
- 2.Participants should be able to provide adequate tumor tissue for biomarker
analysis
- 3.ECOG Performance Status ≤ 1.
- 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1
(RECIST v1.1)
Exclusion Criteria:
-
1. Malignant disease within 5 years prior to the first dose of investigational
drug other than that being treated in this study. Except completely resected
basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary
thyroid carcinoma and completely resected carcinoma in situ of any type.
-
2. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy,
immunotherapy, ADC medication or other anti-cancer treatment within 28 days
prior to the first dose.
- 3.History of severe hypersensitivity reactions to any ingredient of study drugs.
- 4.Pregnant or lactating women.
- 5.Any medical condition that would, in the investigator's judgment, prevent the
patient's participation in the clinical study due to safety concerns, compliance
with clinical study procedures or interpretation of study results.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 11, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Shandong Boan Biotechnology Co., Ltd
Agency class:
Industry
Source:
Shandong Boan Biotechnology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06596915
