Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

NCT06596915 | Recruiting Phase 1

• 1 other identifier: BA1302/CT-CHN-101
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Small Cell Lung Cancer; Pancreatic Adenocarcinoma; Breast Cancer; Melanoma

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities

  Up to 21 days

• adverse events

  Through 28 days after the last study treatment

Secondary Outcomes (8)

• 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

Study Arms (1)

BA1302

EXPERIMENTAL

Drug: BA1302

Interventions

BA1302 DRUG

BA1302 administered intravenously

BA1302

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• Participants should be able to provide adequate tumor tissue for biomarker analysis
• ECOG Performance Status ≤ 1.
• Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

You may not qualify if:

• \. 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.
• History of severe hypersensitivity reactions to any ingredient of study drugs.
• Pregnant or lactating women.
• 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.

Sponsors & Collaborators

• Shandong Boan Biotechnology Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Central Study Contacts

primary investigator

CONTACT

13911233048; Guoj307@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 11, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 6, 2025

Record last verified: 2024-09

Locations

CN (1)