A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies

Shandong Boan Biotechnology Co., Ltd1 site in 1 country167 target enrollmentSeptember 11, 2024

ConditionsNon-Small Cell Lung Cancer Pancreatic Adenocarcinoma Breast Cancer Melanoma

InterventionsBA1302

DrugsBA1302

Overview

Phase: Phase 1
Intervention: BA1302
Conditions: Non-Small Cell Lung Cancer
Sponsor: Shandong Boan Biotechnology Co., Ltd
Enrollment: 167
Locations: 1
Primary Endpoint: Number of participants with dose limiting toxicities
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

September 11, 2024

End Date

December 30, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shandong Boan Biotechnology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Part A: Advanced malignant solid tumors;
•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 ≤
•4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Exclusion Criteria

•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.
•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.

Arms & Interventions

BA1302

Intervention: BA1302

Outcomes

Primary Outcomes

Number of participants with dose limiting toxicities

Time Frame: Up to 21 days

adverse events

Time Frame: Through 28 days after the last study treatment

Secondary Outcomes

Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t)(Up to approximately 1 years)
AUC from time zero to infinity (AUC0-inf)(Up to approximately 1 years)
Area under the concentration-time curve (AUC) at steady state(Up to approximately 1 years)
Maximum serum concentration (Cmax)(Up to approximately 1 years)
Elimination half-life (t1/2)(Up to approximately 1 years)
Incidence of anti-drug antibodies (ADA)(Up to approximately 1 years)
Objective response rate (ORR)(Up to approximately 1 years)
Duration of objective response (DOR)(Up to approximately 1 years)