Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BT02 monoclonal antibody injection

• Registration Number: NCT06404905
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2024-01-24
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-05-04
• Study First Posted: 2024-05-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BT02 treatment	BT02 monoclonal antibody injection	BT02 given intravenously administer in patients with advanced solid tumors.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Within day 28 after administration	Safety
Dose Limiting Toxicity	Within day 28 after administration	safety
Maximum tolerated dose	Within day 28 after administration	Maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.	The time from the date of first study treatment to death from any cause.
Duration of response	From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.	The time from first occurrence of a documented response to disease progression.
Objective Response Rate (ORR)	From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.	The sum of the proportion of subjects with CR or PR
The Pharmacokinetics characteristics of BT02	Within day 28 after administration	Levels of BT02 in blood
Progression-free survival (PFS)	From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.	The time from the date of first study treatment to the first occurrence of disease progression.

Trial Locations

Locations (1)

Cancer Institute and Hospital; 🇨🇳 Beijing, Biejing, China