Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

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

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).

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Breast Cancer; Pancreatic Adenocarcinoma; Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: BA1302

• Study Type: Interventional
• Enrollment (Estimated): 167
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: primary investigator; Phone Number: 13911233048; Email: Guoj307@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BA1302	Drug: BA1302; BA1302 administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with dose limiting toxicities	Up to 21 days
adverse events	Through 28 days after the last study treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Maximum serum concentration (Cmax)	Up to approximately 1 years
Elimination half-life (t1/2)	Up to approximately 1 years
Area under the concentration-time curve (AUC) at steady state	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

Collaborators and Investigators

• Sponsor: Shandong Boan Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: BA1302/CT-CHN-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No