Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer; Pancreatic Adenocarcinoma; Breast Cancer; Melanoma
• Interventions: Drug: BA1302

• Registration Number: NCT06596915
• Lead Sponsor: Shandong Boan Biotechnology Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-11
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 167

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.
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BA1302	BA1302	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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