Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Boan Biotech

Status and phase

Enrolling

Phase 1

Conditions

Breast Cancer

Melanoma

Pancreatic Adenocarcinoma

Non-Small Cell Lung Cancer

Treatments

Drug: BA1302

Study type

Interventional

Funder types

Industry

Identifiers

NCT06596915

BA1302/CT-CHN-101

Details and patient eligibility

About

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).

Enrollment

167 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.
2. Part A: Advanced malignant solid tumors;
3. 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.
1. 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.