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Tests treatment safety and results for Advanced Solid Tumors
Official title Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
ClinicalTrials.gov ID: NCT05620017
What this study is testing
What is BAT8008 for Injection?
BAT8008 for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Also referred to as Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All of the following items could be meet to be enrolled the study
- Age ≥18 years old, both sexes;
- Voluntarily sign the informed consent;
- Patients with advanced or metastatic epithelial-derived solid tumors that have been histopathologically or cytologically confirmed, have failed or...
- According to RECIST1.1, there is at least one measurable tumor lesion;
You likely can't join if
- If you meet any of the following items, you will not be allowed to enroll this study :
- Within 4 weeks before the first administration of the study drug, he has received experimental drug treatment or participated in clinical research of...
- Have received other anti-tumor treatment within 4 weeks before the first administration of the study drug, such as chemotherapy, radiotherapy...
- Within 2 weeks before the first administration of the study drug, he has received the treatment of traditional Chinese medicine, Chinese patent...
- 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...
- Major surgery (excluding the operation for diagnosis) is required within 4 weeks before the first administration of the study drug or is expected to...
See the full eligibility criteria
- All of the following items could be meet to be enrolled the study
- Age ≥18 years old, both sexes;
- Voluntarily sign the informed consent;
- 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...
- According to RECIST1.1, there is at least one measurable tumor lesion;
- The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1;
- Investigators assessed the expected survival of ≥12 weeks;
- Adequate organ and bone marrow reserve function
- 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;
- Willing to provide previously archived or fresh tumor tissue samples
- Able to understand the test requirements, willing and able to comply with the test and follow-up procedures.
- If you meet any of the following items, you will not be allowed to enroll this study :
- 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;
- 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...
- 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...
- 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...
- 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;
- Patients who have received Trop2 targeted therapy previously;
- 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...
- Have a history of allograft cell or solid organ transplantation;
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.