Clincosm LogoSign in Get a demo

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

Sponsor
Bio-Thera Solutions (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05405621
Collaborator
(none)
48
Enrollment
8
Arms
30
Anticipated Duration (Months)

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dose-limiting toxicity(DLT) [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) [126 days after first dosing]

      Maximum observed plasma or serum concentration

    2. Immunogenicity [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 [126 days after first dosing]

      area under the serum concentration versus time curve from time zero to infinity and to time λ

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bio-Thera Solutions

    Investigators

    • Principal Investigator: Prunella Blinman, Concord Repatriation General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bio-Thera Solutions
    ClinicalTrials.gov Identifier:
    NCT05405621
    Other Study ID Numbers:
    • BAT-8009-001-CR
    First Posted:
    Jun 6, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Exatecan

    Study Results

    No Results Posted as of Jun 8, 2022