Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: BT02 monoclonal antibody injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06404905

BT02-101

Details and patient eligibility

About

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors

Full description

Overall study design:

This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 at the time of signing the informed consent form, male or female;
2. Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
3. Adequate organ and hematologic function;
4. Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
5. ECOG performance status 0~1;
6. Life expectancy ≥ 3 months;
7. Good compliance and be willing to follow-up visit.

Exclusion criteria

1. Receive treatment before study as below:

   a) Previous systematic anti-cancer therapy;

2. Active or prior documented autoimmune disease within past 2 years;

3. History of clinically significant cardiovascular disease;

4. Significant acute or chronic infections;

5. Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;

6. Any prior Grade≥3 irAE while receiving immunotherapy;

7. Unstable brain metastasis or meningeal metastasis with clinical symptoms;

8. Patients with mental disorders or poor compliance;

9. Known alcohol or drug abuse;

10. Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

BT02 treatment

Experimental group

Description:

BT02 given intravenously administer in patients with advanced solid tumors.

Treatment:

Drug: BT02 monoclonal antibody injection