Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Main purpose:

• To evaluate the safety and tolerability of BAT6021 injection in the treatment of locally advanced or metastatic solid tumors with single drug or combined with tislelizumab(anti PD-1 monoclonal antibody);

• Explore the maximum tolerated dose (MTD) or maximum dosing dose (MAD) of BAT6021 injection monotherapy or in combination with tislelizumab and provide recommended dose and reasonable dosing regimen for phase II or subsequent clinical studies.

Secondary purpose:

• To evaluate the pharmacokinetic (PK) characteristics of BAT6021 injection with single or multiple doses of tislelizumab in patients with locally advanced or metastatic solid tumors;

• Evaluate the immunogenicity of BAT6021 injection;

• To evaluate the pharmacodynamics of BAT6021 injection;

• Preliminary evaluation of the anti-tumor efficacy of BAT6021 injection alone or in combination with tislelizumab.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio-Thera Solutions

Criteria

Inclusion Criteria:

1. Age: ≥18 years old, gender: male or female;

2. The expected survival was assessed as at least 3 months;

3. ECOG physical status score is required to be 0 or 1;

4. Patients with locally advanced or metastatic malignant solid tumors confirmed by histology or cytology without standard therapy, failure of standard therapy, or inapplicable standard therapy;

5. According to RECIST 1.1, there must be evaluable tumor focus in dose increase stage, and at least one measurable tumor focus in dose expansion stage;

6. Fertile women must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use an effective method of birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dose. Male patients must agree to use an effective contraceptive method for the duration of the study until 6 months after the study's last dosing; Postmenopausal women must be amenorrhea for at least 12 months before they are considered infertile.

Exclusion Criteria:

1. Prior treatment with anti-TiGit monoclonal antibody or anti-TiGit active double antibody;

2. Are receiving or are expected to receive other anti-tumor therapies during the study period, including but not limited to chemotherapy, radiotherapy, immunotherapy, hormone therapy (except alternative therapy), targeted therapy, biotherapy and proprietary Chinese medicines with anti-tumor effects;

3, first study drug delivery from previous antineoplastic therapy (chemotherapy and endocrine therapy, targeted therapy, immunotherapy, or tumor embolization, etc.) less than three weeks or five half-lives of longer (in time), the last time or distance large radiotherapy under 3 weeks (range palliative radiotherapy for bone metastases should full 2 weeks). Or less than 2 weeks since the last treatment with anti-tumor indications of proprietary Chinese medicine/immunomodulatory drugs (including thymosin, interferon, interleukin, etc.), or less than 8 weeks since the last radiation therapy;

4. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first use of the investigational drug;

5. Have received live/attenuated or mRNA vaccine within 4 weeks prior to screening or plan to receive live/attenuated or mRNA vaccine during the study period;

6. Pregnant or lactating women;

7. Patients whose AE caused by previous antitumor therapy did not recover to CTCAE 5.0≤ 1, except hair loss;

8. Patients with primary CNS tumor or symptomatic CNS metastasis should be excluded. Patients with meningeal metastasis or previous history of epilepsy should be excluded. Patients with clinically controlled CNS metastases who are asymptomatic or symptomatic but stable as determined by the investigator may be included, provided that the following conditions are met: Disease stability ≥4 weeks before first administration; B. Cranial MRI enhancement found no evidence of progression of central nervous system disease within 4 weeks prior to initial administration; C. Antiepileptic drugs have been discontinued and prednisone dosage ≤10mg/ day or equivalent hormone dosage ≥2 weeks before the first medication;

9. Patients who underwent major organ surgery (excluding needle biopsy) within 4 weeks prior to the first use of the study drug or have not recovered from the surgery, or have suffered significant trauma, or need to undergo elective surgery during the study period;

10. Those with a history of tissue or organ transplantation;