A Single-arm, Open, Dose-increasing Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006 in Patients with Her2-positive Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Dose limiting toxicity (DLT)
Study Overview
Brief Summary
Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of BAT1006 after single and multiple dosing; 2) To study the immunogenicity of BAT1006; 3) Preliminary evaluation of anti-tumor efficacy of BAT1006.
Detailed Description
This trial is an open phase I, dose-escalation clinical study. The first administration period was the 21st day, namely the DLT observation period. DLT observation was conducted to explore the safety, tolerability, pharmacokinetics and immunogenicity of MTD, single administration. After the observation period of DLT, the drug was administered once every 3 weeks, and the tolerance, pharmacokinetics, immunogenicity and preliminary effectiveness of multiple administration were evaluated. If some dose groups show better efficacy, the investigator and the sponsor may select 1-2 dose groups that have been found to have efficacy after negotiation and discussion for extended study to further explore the safety and efficacy of the drug.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A1/3mg/kg
Dose: 3mg/kg
Intervention: BAT1006 (Drug)
A2/6mg/kg
Dose: 6mg/kg
Intervention: BAT1006 (Drug)
A3/10mg/kg
Dose: 10mg/kg
Intervention: BAT1006 (Drug)
A4/15mg/kg
Dose: 15mg/kg
Intervention: BAT1006 (Drug)
A5/20mg/kg
Dose: 20mg/kg
Intervention: BAT1006 (Drug)
Outcomes
Primary Outcomes
Dose limiting toxicity (DLT)
Time Frame: 21 days
Dose-limiting toxicity (DLT) is defined as any of the following adverse events (CTCAE Version 5.0 classification for the evaluation of adverse effects) that occur during the first treatment cycle that are definitely or possibly related to the investigatory drug: 1. Grade ≥3 non-hematological toxicity (nausea, vomiting and diarrhea can be relieved within 3 days after supportive treatment, except for infusion reactions that can be recovered within 2 hours after symptomatic treatment); 2. Hematological toxicity 2.1 Grade ≥3 neutropenia with fever, or grade 3 thrombocytopenia with significant bleeding; 2.2 Grade ≥4 hematologic toxicity: thrombocytopenia for more than 5 days, or grade 4 neutropenia for more than 7 days; 3. LVEF decreased by \> 15% or LVEF value decreased by \< 50% from baseline; 4. In the case of other SAE or AE that the researcher considers unacceptable, the researcher will communicate with the sponsor to decide whether to judge it as DLT.
Maximum tolerance dose（MTD）
Time Frame: 21 days
MTD is defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period
Secondary Outcomes
No secondary outcomes reported