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Recruiting NCT06927349

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.

Phase I Interventional Advanced Solid Tumours

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: BA1301.
Who it may be relevant to
Registry conditions: Advanced Solid Tumours. Basic parameters: 18 years — 75 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

An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1301in Participants With Advanced Solid Tumors.

Overview

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1301 in participants with advanced solid tumors.

Interventions

  • Drug BA1301
    BA1301 is administered intravenously once every three weeks.

Primary outcome measures

  • Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0). [Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.]

Eligibility criteria

Inclusion criteria

  • Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan;
  • Age ≥ 18 years old and ≤ 75 years old, male or female;
  • Patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histologically or cytologically confirmed by standard therapy failure or refusal or inability to tolerate standard treatment regimens.
  • Agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of CLDN18.2 expression.
  • Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1.
  • At least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (RECIST1.1).
  • Adequate organ function.
  • Estimated survival ≥ 3 months;
  • Negative blood pregnancy test result for females of childbearing potential at screening.

Exclusion criteria

  • Poorly controlled hypertension as judged by the investigator
  • Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC drug therapy, major surgery, or other anti-cancer therapy within 28 days prior to the first dose of trial drug.
  • Known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol;
  • Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody;
  • Pregnant or lactating females, those who have recently planned to become pregnant;
  • Those who have participated in and received any clinical trial drugs (excluding vitamins and minerals) or clinical trial device intervention within 28 days before signing informed consent;
  • Other serious physical or psychiatric illness or laboratory test abnormalities at screening that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.

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
  • Cancer Hospital Affiliated to Harbin Medical University — Harbin

Identifiers

NCT: NCT06927349 · BA1301/CT-CHN-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗