Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06596915

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Led by Shandong Boan Biotechnology Co., Ltd · Updated on 2025-06-06

167

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Metastatic or unresectable solid malignancy confirmed by tissue testing, with progression after or intolerance to standard therapy or no standard therapy available
  • For Part A: advanced malignant solid tumors
  • For Part B: metastatic melanoma, advanced breast cancer, advanced non-small cell lung cancer, or advanced pancreatic adenocarcinoma
  • Ability to provide adequate tumor tissue for biomarker analysis
  • ECOG Performance Status of 0 or 1
  • Measurable disease according to RECIST v1.1 criteria
Not Eligible

You will not qualify if you...

  • Malignant disease within 5 years before first dose, except certain completely resected skin cancers and carcinoma in situ
  • Received chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication, or other anti-cancer treatment within 28 days before first dose
  • History of severe allergic reactions to any study drug ingredients
  • Pregnant or lactating women
  • Any medical condition that may prevent safe participation or affect study compliance or result interpretation according to investigator judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Cancer Hospital

Beijing, China

Actively Recruiting

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Research Team

P

primary investigator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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