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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

Tracking Information
First Submitted Date  ICMJE May 30, 2022
First Posted Date  ICMJE June 6, 2022
Last Update Posted Date October 27, 2022
Actual Study Start Date  ICMJE August 2, 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2022)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2022)
  • Cmax (Maximum serum concentration) [ Time Frame: 126 days after first dosing ]
    Maximum observed plasma or serum concentration
  • Immunogenicity [ Time Frame: 126 days after first dosing ]
    Presence of ADAs / neutralizing antibodies (NAbs).
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2022)
  • Cmax (Maximum serum concentration) [ Time Frame: every cycle until cycle 6 (one cycle equals 3 weeks) ]
    Maximum observed plasma or serum concentration
  • Immunogenicity [ Time Frame: every cycle until cycle 6 (one cycle equals 3 weeks) ]
    Presence of ADAs / neutralizing antibodies (NAbs).
  • AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration [ Time Frame: every cycle until cycle 6 (one cycle equals 3 weeks) ]
    area under the serum concentration versus time curve from time zero to infinity and to time λ
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009
Official Title  ICMJE A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced/Metastatic Solid Tumours
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort 2
    Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort 3
    Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort 4
    Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort 5
    Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort6
    Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort 7
    Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
  • Experimental: Cohort 8
    Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W)
    Intervention: Drug: BAT8009 for Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2022)		 48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cailing Gu +86-20-22233606 clgu@bio-thera.com
Contact: Zhaohe Wang, Ph.D 86-20-32203220 zhwang@bio-thera.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05405621
Other Study ID Numbers  ICMJE BAT-8009-001-CR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share IPD
Current Responsible Party Bio-Thera Solutions
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bio-Thera Solutions
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Zhang, M.D, Ph.D Sun Yat-sen University
PRS Account Bio-Thera Solutions
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP