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

NCT06927349 | Recruiting Phase 1

• 1 other identifier: BA1301/CT-CHN-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).

  From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.

Study Arms (1)

BA1301

EXPERIMENTAL

BA1301 is administered intravenously once every three weeks.

Drug: BA1301

Interventions

BA1301 DRUG

BA1301 is administered intravenously once every three weeks.

BA1301

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Boan Biotechnology Co., Ltd: lead

Study Sites (1)

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

Central Study Contacts

Zhang Yanqiao

CONTACT

13845120210; yanqiaozhang@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: April 7, 2025
• First Posted: April 15, 2025
• Study Start: January 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)