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Recruiting NCT06596915

Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Phase I Interventional Non-Small Cell Lung Cancer Pancreatic Adenocarcinoma Breast Cancer Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BA1302.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer, Pancreatic Adenocarcinoma, Breast Cancer, Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug BA1302
    BA1302 administered intravenously

Primary outcome measures

  • 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 outcome measures (8)
  • Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) [Time frame: Up to approximately 1 years]
  • AUC from time zero to infinity (AUC0-inf) [Time frame: Up to approximately 1 years]
  • Maximum serum concentration (Cmax) [Time frame: Up to approximately 1 years]
  • Elimination half-life (t1/2) [Time frame: Up to approximately 1 years]
  • Area under the concentration-time curve (AUC) at steady state [Time frame: Up to approximately 1 years]
  • Incidence of anti-drug antibodies (ADA) [Time frame: Up to approximately 1 years]
  • Objective response rate (ORR) [Time frame: Up to approximately 1 years]
  • Duration of objective response (DOR) [Time frame: Up to approximately 1 years]

Eligibility criteria

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.
  • 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 ≤ 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT06596915 · BA1302/CT-CHN-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗