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

NCT ID: NCT06927349

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Advanced Solid Tumours

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BA1301

BA1301 is administered intravenously once every three weeks.

Group Type: EXPERIMENTAL

BA1301

Intervention Type: DRUG

BA1301 is administered intravenously once every three weeks.

Interventions

BA1301

BA1301 is administered intravenously once every three weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan;

2. Age ≥ 18 years old and ≤ 75 years old, male or female;

3. 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.

4. Agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of CLDN18.2 expression.

5. Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1.

6. At least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (RECIST1.1).

7. Adequate organ function.

8. Estimated survival ≥ 3 months;

9. Negative blood pregnancy test result for females of childbearing potential at screening.

Exclusion Criteria

1. Poorly controlled hypertension as judged by the investigator

2. 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.

3. Known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol;

4. Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody;

5. Pregnant or lactating females, those who have recently planned to become pregnant;

6. 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;

7. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Boan Biotechnology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang Yanqiao

Role: CONTACT

yanqiaozhang@126.com

13845120210

Facility Contacts

Zhang Yanqiao

Role: primary

yanqiaozhang@126.com

13845120210

Other Identifiers

BA1301/CT-CHN-101

Identifier Type: -

Identifier Source: org_study_id