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

NCT ID: NCT05620017

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2027-05-31

Brief 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.

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C/2.4mg/kg

Drug：BAT8008 for Injection,2.4mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

D/3.6mg/kg

Drug：BAT8008 for Injection,3.6mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

E/4.8mg/kg

Drug：BAT8008 for Injection,4.8mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

F/6.0mg/kg

Drug：BAT8008 for Injection,6.0mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

G/7.2mg/kg

Drug：BAT8008 for Injection,7.2mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

A/0.8mg/kg

Drug：BAT8008 for Injection,0.8mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

B/1.2mg/kg

Drug：BAT8008 for Injection,1.2mg/kg

Group Type: EXPERIMENTAL

BAT8008 for Injection

Intervention Type: DRUG

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.

Interventions

BAT8008 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.

Intervention Type: DRUG

Other Intervention Names

Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate

Eligibility Criteria

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 informed consent;

3. Patients with advanced or metastatic epithelial-derived solid tumors that have been histopathologically or cytologically 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 (ECOG) 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 birth control/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

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bio-Thera Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weier Song

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

WeiNing Li

Role: CONTACT

wnli@bio-thera.com

020-31702863（8028）

Zhaohe Wang

Role: CONTACT

Facility Contacts

Qi Zhou

Role: primary

qizhou9128@163.com

86-13708384529

Weihong Tan

Role: primary

Other Identifiers

BAT-8008-001-CR

Identifier Type: -

Identifier Source: org_study_id