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

Phase
Recruitment status
Participants
Lead sponsor
Bio-Thera Solutions
Start date
Number of sites

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.
Short title
Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
Official title
A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
Bio-Thera Solutions
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Dose limiting toxicity (DLT)

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

    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

  2. Maximum tolerated dose (MTD)

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

    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.

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

    Timeframe: 91 days after first dose of BAT8008

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

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

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;
Sources for eligibility

  • Affiliated Cancer Hospital of Chongqing UniversityChongqing, ChinaRecruiting
  • Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)