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Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009

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: NCT05405621
Recruitment Status : Recruiting
First Posted : June 6, 2022
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Bio-Thera Solutions

Study Description
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Brief Summary:

Primary objectives:

  • To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours.
  • To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).

Condition or disease Intervention/treatment Phase
Locally Advanced/Metastatic Solid Tumours Drug: BAT8009 for Injection Phase 1

Detailed Description:
This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort 2
Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort 3
Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort 4
Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort 5
Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort6
Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort 7
Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate
Experimental: Cohort 8
Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W)
 Drug: BAT8009 for Injection
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
Other Name: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity(DLT) [ Time Frame: A minimum of 21 days after first dose of BAT8009 ]
    A DLT is defined as a toxicity occurring during the DLT observation period


Secondary Outcome Measures :
  1. Cmax (Maximum serum concentration) [ Time Frame: 126 days after first dosing ]
    Maximum observed plasma or serum concentration

  2. Immunogenicity [ Time Frame: 126 days after first dosing ]
    Presence of ADAs / neutralizing antibodies (NAbs).

  3. AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration [ Time Frame: 126 days after first dosing ]
    area under the serum concentration versus time curve from time zero to infinity and to time λ


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
  2. Aged ≥ 18 years and ≤ 75 years.
  3. Life expectancy ≥ 3 months.
  4. ECOG performance status ≤ 1.
  5. Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy.
  6. Has measurable or evaluable disease per RECIST v1.1.
  7. Adequate haematological, liver, kidney, cardiac and coagulation function.
  8. Is willing to provide pre-existing diagnostic or resected tumour samples (if available).
  9. Female patients must: Be of non-child-bearing potential; Male patients must: be willing not to donate sperm.
  10. Must agree to adhere to the current state and national advice regarding minimising exposure to COVID-19 from the first Screening visit until the end of study (28-day Safety Follow-up Visit).

Exclusion Criteria:

  1. Females who are pregnant or nursing.
  2. Receiving concurrent anticancer therapy or investigational therapy.
  3. Persisting AEs that are > Grade 1 from prior antitumour treatment as per CTCAE v5.0.
  4. Patients with primacy central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.
  5. Had major surgery within 28 days of the Screening visit.
  6. History of autologous transplantation ≤ 3 months.
  7. History of severe infection deemed clinically significant by the PI or designee within 4 weeks.
  8. History of human immunodeficiency virus (HIV) infection.
  9. Active hepatitis B or C.
  10. History of a Grade 3 or Grade 4 allergic reaction to treatment with other antibodies.
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): NCT05405621


Contacts
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Contact: Cailing Gu +86-20-22233606 clgu@bio-thera.com
Contact: Zhaohe Wang, Ph.D 86-20-32203220 zhwang@bio-thera.com

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Li Zhang         
Sponsors and Collaborators
Bio-Thera Solutions
Investigators
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Principal Investigator: Li Zhang, M.D, Ph.D Sun Yat-sen University
More Information
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Responsible Party: Bio-Thera Solutions
ClinicalTrials.gov Identifier: NCT05405621    
Other Study ID Numbers: BAT-8009-001-CR
First Posted: June 6, 2022    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exatecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents