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Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05620017
Recruitment Status : Not yet recruiting
First Posted : November 17, 2022
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
Bio-Thera Solutions

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BAT8008 for Injection Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: A/0.8mg/kg
Drug：BAT8008 for Injection,0.8mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Experimental: B/1.2mg/kg
Drug：BAT8008 for Injection,1.2mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Experimental: C/2.4mg/kg
Drug：BAT8008 for Injection,2.4mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Experimental: D/3.6mg/kg
Drug：BAT8008 for Injection,3.6mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Experimental: E/4.8mg/kg
Drug：BAT8008 for Injection,4.8mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Experimental: F/6.0mg/kg
Drug：BAT8008 for Injection,6.0mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate
Experimental: G/7.2mg/kg
Drug：BAT8008 for Injection,7.2mg/kg
 Drug: BAT8008 for Injection
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.
Other Name: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days) ]
    DLT was defined as grade 3 or higher toxicity associated with the investigational product that occurred within 21 days of the subject's initial administration

  2. Maximum tolerated dose (MTD) [ Time Frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days) ]
    MTD was defined as exploration in a dose group observed ≤1/6 of subjects during the DLT evaluation period to the highest dose level of DLT.


Secondary Outcome Measures :
  1. AUC(0-inf)after cycle 6 administration [ Time Frame: 91 days after first dose of BAT8008 ]
    The area under the concentration-time curve extrapolated from time 0 to infinity


Other Outcome Measures:
  1. Presence of ADA/nentralizing antibodies（NAbs） [ Time Frame: 91 days after first dose of BAT8008 ]
    presence of anti-drug antibody/ nentralizing antibodies


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05620017


Contacts
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Contact: WeiNing Li 020-31702863（8028） wnli@bio-thera.com
Contact: Zhaohe Wang

Sponsors and Collaborators
Bio-Thera Solutions
Investigators
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Principal Investigator: Weier Song Sun Yat-sen Memorial Hospital,Sun Yat-sen University
More Information
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Responsible Party: Bio-Thera Solutions
ClinicalTrials.gov Identifier: NCT05620017    
Other Study ID Numbers: BAT-8008-001-CR
First Posted: November 17, 2022    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No