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

NCT05620017 | Recruiting Phase 1

• 1 other identifier: BAT-8008-001-CR
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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.

  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

  91 days after first dose of BAT8008

Other Outcomes (1)

• Presence of ADA/nentralizing antibodies（NAbs）

  91 days after first dose of BAT8008

Study Arms (7)

A/0.8mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,0.8mg/kg

Drug: BAT8008 for Injection

B/1.2mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,1.2mg/kg

Drug: BAT8008 for Injection

C/2.4mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,2.4mg/kg

Drug: BAT8008 for Injection

D/3.6mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,3.6mg/kg

Drug: BAT8008 for Injection

E/4.8mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,4.8mg/kg

Drug: BAT8008 for Injection

F/6.0mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,6.0mg/kg

Drug: BAT8008 for Injection

G/7.2mg/kg

EXPERIMENTAL

Drug：BAT8008 for Injection,7.2mg/kg

Drug: BAT8008 for Injection

Interventions

BAT8008 for Injection 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.

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

A/0.8mg/kg; B/1.2mg/kg; C/2.4mg/kg; D/3.6mg/kg; E/4.8mg/kg; F/6.0mg/kg; G/7.2mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following items could be meet to be enrolled the study
• Age ≥18 years old, both sexes;
• Voluntarily sign the informed consent;
• 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.
• According to RECIST1.1, there is at least one measurable tumor lesion;
• The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1;
• Investigators assessed the expected survival of ≥12 weeks;
• Adequate organ and bone marrow reserve function
• 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;
• Willing to provide previously archived or fresh tumor tissue samples
• Able to understand the test requirements, willing and able to comply with the test and follow-up procedures.

You may not qualify if:

• If you meet any of the following items, you will not be allowed to enroll this study :
• 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;
• 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);
• 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;
• 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;
• 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;
• Patients who have received Trop2 targeted therapy previously;
• 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;
• Have a history of allograft cell or solid organ transplantation;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (2)

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Weier Song

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WeiNing Li

CONTACT

020-31702863（8028）; wnli@bio-thera.com

Zhaohe Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 17, 2022
• Study Start: November 30, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CN (2)