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Trial Title:
Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
NCT ID:
NCT05620017
Condition:
Advanced Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BAT8008 for Injection
Description:
Intravenous infusion, once every 2 weeks (Q2W). It is recommended that the infusion time
of the first cycle should be ≥ 3 hours. If no infusion reaction occurs, the subsequent
circulation can be completed within 1-2 hours.
Arm group label:
A/0.8mg/kg
Arm group label:
B/1.2mg/kg
Arm group label:
C/2.4mg/kg
Arm group label:
D/3.6mg/kg
Arm group label:
E/4.8mg/kg
Arm group label:
F/6.0mg/kg
Arm group label:
G/7.2mg/kg
Other name:
Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Summary:
Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients
with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the
recommended dose for subsequent clinical trials.
Detailed description:
In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid
titration and a "3+3" dose-increasing design were used to explore the safety,
tolerability and PK characteristics of BAT8008 for injection in patients with advanced
solid tumors. During the dose-escalation test, appropriate doses were selected for the
extended study according to the previous study data.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
All of the following items could be meet to be enrolled the study
1. Age ≥18 years old, both sexes;
2. Voluntarily sign the informed consent;
3. Patients with advanced or metastatic epithelial-derived solid tumors that have been
histopathologically or cytologically confirmed, have failed or not been treated with
standard therapy, have been intolerant to or have refused standard therapy.
4. According to RECIST1.1, there is at least one measurable tumor lesion;
5. The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a
score of 0 or 1;
6. Investigators assessed the expected survival of ≥12 weeks;
7. Adequate organ and bone marrow reserve function
8. Fertile female patients willing to use effective birth control/contraception to
prevent pregnancy during the study period. Male patients must consent to use an
effective method of contraception during the study;
9. Willing to provide previously archived or fresh tumor tissue samples
10. Able to understand the test requirements, willing and able to comply with the test
and follow-up procedures.
Exclusion Criteria:
If you meet any of the following items, you will not be allowed to enroll this study :
1. Within 4 weeks before the first administration of the study drug, he has received
experimental drug treatment or participated in clinical research of medical devices;
2. Have received other anti-tumor treatment within 4 weeks before the first
administration of the study drug, such as chemotherapy, radiotherapy (palliative
radiotherapy should be completed within 2 weeks before the first administration),
targeted therapy/immunotherapy (at least 4 weeks or at least 5 half-life, whichever
is shorter), hormone therapy (except alternative therapy);
3. Within 2 weeks before the first administration of the study drug, he has received
the treatment of traditional Chinese medicine, Chinese patent medicine or
immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with
anti-tumor effect;
4. Before the first administration of the study drug, AE (CTCAE5.0) caused by previous
anti-tumor treatment was still greater than grade 1, except for the following
conditions: a. alopecia; B pigmentation; c. The distal toxicity caused by
chemotherapy and radiotherapy can not be further recovered after judgment;
5. Major surgery (excluding the operation for diagnosis) is required within 4 weeks
before the first administration of the study drug or is expected to be performed
during the study period;
6. Patients who have received Trop2 targeted therapy previously;
7. Those who have received the treatment containing exatecan or irinotecan and other
topoisomerase I inhibitor drugs in the past and have experienced drug related AE ≥
grade 3 or treatment failure of topoisomerase I inhibitor;
8. Have a history of allograft cell or solid organ transplantation;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Bio-Thera Solutions
Agency class:
Industry
Source:
Bio-Thera Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620017
