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

October 25, 2022 updated by: Bio-Thera Solutions

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
A minimum of 21 days after first dose of BAT8009

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax (Maximum serum concentration)
Time Frame: 126 days after first dosing
Maximum observed plasma or serum concentration
126 days after first dosing
Immunogenicity
Time Frame: 126 days after first dosing
Presence of ADAs / neutralizing antibodies (NAbs).
126 days after first dosing
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
126 days after first dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bio-Thera Solutions

Investigators

  • Principal Investigator: Li Zhang, M.D, Ph.D, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAT-8009-001-CR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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