ClinicalTrials.gg
Sign In
Status unknownNCT05405621Updated Oct 27, 2022

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

A Phase 1 interventional study of BAT8009 for Injection in Locally Advanced/Metastatic Solid Tumours, sponsored by Bio-Thera Solutions. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Bio-Thera Solutions · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).
Read the 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.

02

Conditions studied

  • Locally Advanced/Metastatic Solid Tumours
03

In context

Lead sponsor

Bio-Thera Solutions is the lead sponsor of 57 studies on the registry; 4 are open to participants now.

Browse Bio-Thera Solutions studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    Experimental: BAT8009 for Injection 0.6 mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort 2

    Drug: BAT8009 for Injection 1.2 mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort 3

    Drug: BAT8009 for Injection 2.4 mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort 4

    Drug: BAT8009 for Injection 3.6mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort 5

    Drug: BAT8009 for Injection 4.8mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort6

    Drug: BAT8009 for Injection 6.0mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort 7

    Drug: BAT8009 for Injection 7.2mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

  • Experimental
    Cohort 8

    Drug: BAT8009 for Injection 8.4mg/kg (frequency: Q3W)

    Drug: BAT8009 for Injection

Interventions

  • DrugBAT8009 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.

    Also known as: Recombinant Humanized Anti-B7H3 Monoclonal Antibody-Exatecan Conjugate

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity(DLT)

    A DLT is defined as a toxicity occurring during the DLT observation period

    Time frame: A minimum of 21 days after first dose of BAT8009

Secondary outcomes

  1. Cmax (Maximum serum concentration)

    Maximum observed plasma or serum concentration

    Time frame: 126 days after first dosing

  2. Immunogenicity

    Presence of ADAs / neutralizing antibodies (NAbs).

    Time frame: 126 days after first dosing

  3. AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration

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

    Time frame: 126 days after first dosing

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China
    • Li Zhang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — no plan to share IPD

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05405621
Lead sponsor
Bio-Thera Solutions
Responsible party
Sponsor
First posted
Jun 6, 2022
Start date
Aug 2, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 27, 2022

Study contacts

Cailing Gu
Contact
clgu@bio-thera.com
+86-20-22233606
Zhaohe Wang, Ph.D
Contact
zhwang@bio-thera.com
86-20-32203220
Li Zhang, M.D, Ph.D
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Bio-Thera Solutions →

Start the discussion