Clinical trial NCT06404905: Clinical Trial of BT02 in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Advanced Solid Tumors
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: Within day 28 after administration
measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Within day 28 after administration
measure: Maximum tolerated dose
timeFrame: Within day 28 after administration
Secondary outcomes:
measure: The Pharmacokinetics characteristics of BT02
timeFrame: Within day 28 after administration
measure: Progression-free survival (PFS)
timeFrame: 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.
measure: Overall survival (OS)
timeFrame: 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.
measure: Duration of response
timeFrame: 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.
measure: Objective Response Rate (ORR)
timeFrame: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital
state: Biejing
Study officials:
References: