ClinicalTrials.gg
RecruitingNCT05620017Updated Feb 9, 2026

Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection

A Phase 1 interventional study of BAT8008 for Injection in Advanced Solid Tumors, sponsored by Bio-Thera Solutions. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

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

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
182
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.

Read the detailed description

In this multi-center, open, dose-increasing, dose-expanding Phase I clinical study, rapid titration and a "3+3" dose-increasing design were used to explore the safety, tolerability and PK characteristics of BAT8008 for injection in patients with advanced solid tumors. During the dose-escalation test, appropriate doses were selected for the extended study according to the previous study data.

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

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

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

04

Who can participate

Ages eligible
18 Years and older
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

All of the following items could be meet to be enrolled the study

  1. Age ≥18 years old, both sexes;
  2. Voluntarily sign the ;
  3. Patients with advanced or epithelial-derived solid tumors that have been histopathologically or confirmed, have failed or not been treated with standard therapy, have been intolerant to or have refused standard therapy.
  4. According to RECIST1.1, there is at least one measurable tumor lesion;
  5. The Eastern Collaborative Oncology Group () Performance Status score requires a score of 0 or 1;
  6. Investigators assessed the expected survival of ≥12 weeks;
  7. Adequate organ and bone marrow reserve function
  8. Fertile female patients willing to use effective /contraception to prevent pregnancy during the study period. Male patients must consent to use an effective method of contraception during the study;
  9. Willing to provide previously archived or fresh tumor tissue samples
  10. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures.

Exclusion criteria

Exclusion Criteria:

If you meet any of the following items, you will not be allowed to enroll this study :

  1. Within 4 weeks before the first administration of the study drug, he has received experimental drug treatment or participated in clinical research of medical devices;
  2. Have received other anti-tumor treatment within 4 weeks before the first administration of the study drug, such as chemotherapy, radiotherapy (palliative radiotherapy should be completed within 2 weeks before the first administration), targeted therapy/immunotherapy (at least 4 weeks or at least 5 half-life, whichever is shorter), hormone therapy (except alternative therapy);
  3. Within 2 weeks before the first administration of the study drug, he has received the treatment of traditional Chinese medicine, Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor effect;
  4. Before the first administration of the study drug, AE (CTCAE5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following conditions: a. alopecia; B pigmentation; c. The distal toxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment;
  5. Major surgery (excluding the operation for diagnosis) is required within 4 weeks before the first administration of the study drug or is expected to be performed during the study period;
  6. Patients who have received Trop2 targeted therapy previously;
  7. Those who have received the treatment containing exatecan or irinotecan and other topoisomerase I inhibitor drugs in the past and have experienced drug related AE ≥ grade 3 or treatment failure of topoisomerase I inhibitor;
  8. Have a history of allograft cell or solid organ transplantation;
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

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

Study arms

  • Experimental
    A/0.8mg/kg

    Drug:BAT8008 for Injection,0.8mg/kg

    Drug: BAT8008 for Injection

  • Experimental
    B/1.2mg/kg

    Drug:BAT8008 for Injection,1.2mg/kg

    Drug: BAT8008 for Injection

  • Experimental
    C/2.4mg/kg

    Drug:BAT8008 for Injection,2.4mg/kg

    Drug: BAT8008 for Injection

  • Experimental
    D/3.6mg/kg

    Drug:BAT8008 for Injection,3.6mg/kg

    Drug: BAT8008 for Injection

  • Experimental
    E/4.8mg/kg

    Drug:BAT8008 for Injection,4.8mg/kg

    Drug: BAT8008 for Injection

  • Experimental
    F/6.0mg/kg

    Drug:BAT8008 for Injection,6.0mg/kg

    Drug: BAT8008 for Injection

  • Experimental
    G/7.2mg/kg

    Drug:BAT8008 for Injection,7.2mg/kg

    Drug: BAT8008 for Injection

Interventions

  • DrugBAT8008 for Injection

    Intravenous infusion, once every 2 weeks (Q2W). It is recommended that the infusion time of the first cycle should be ≥ 3 hours. If no infusion reaction occurs, the subsequent circulation can be completed within 1-2 hours.

    Also known as: Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT)

    DLT was defined as grade 3 or higher toxicity associated with the investigational product that occurred within 21 days of the subject's initial administration

    Time frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)

  2. Maximum tolerated dose (MTD)

    MTD was defined as exploration in a dose group observed ≤1/6 of subjects during the DLT evaluation period to the highest dose level of DLT.

    Time frame: At the end of Cycle 1( first cycle is 21 days, subsequent cycles are 14 days)

Secondary outcomes

  1. AUC(0-inf)after cycle 6 administration

    The area under the concentration-time curve extrapolated from time 0 to infinity

    Time frame: 91 days after first dose of BAT8008

Other outcomes

  1. Presence of ADA/nentralizing antibodies(NAbs)

    presence of anti-drug antibody/ nentralizing antibodies

    Time frame: 91 days after first dose of BAT8008

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05620017
Responsible party
Sponsor
First posted
Nov 17, 2022
Start date
Nov 30, 2022
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Feb 9, 2026

Study contacts

WeiNing Li
Contact
wnli@bio-thera.com
020-31702863(8028)
Zhaohe Wang
Contact
Weier Song
principal investigator · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Oversight

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

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