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

NCT05120375 | Terminated Phase 1

• 1 other identifier: BAT-6021-001-CR
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  Dose-limiting toxicity (DLT) is defined as AE that occurred during the observation period of DLT and are considered to be at least possibly related to the drug under study, as follows: Grade 5 toxicity; Hematological toxicity: Grade 4 anemia; Grade 4 thrombocytopenia lasting ≥7 days; Grade 3 thrombocytopenia with bleeding(grade ≥2) or requiring platelet transfusion; Grade 4 neutropenia ≥7 days or grade 3 neutropenia with infection ≥7 days; Grade ≥3 neutropenia with fever; Non-hematological toxicity: Grade ≥3 non-hematological toxicity (AE not detected by simple laboratory tests); Grade 3 or 4 non-hematological toxicity detected by clinical laboratory tests that meets any of the following criteria: (1) Clinical intervention is required; (2) Resulting in hospitalization; (3) Any treatment-related toxicities resulting in a delay of more than 2 weeks in cycle 2 administration;

  3 weeks

• maximum tolerated dose (MTD)

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

  3 weeks

Secondary Outcomes (2)

• Pharmacokinetics (PK)

  every cycle until cycle 6 (one cycle equals 3 weeks)

• Immunogenicity

  every cycle until cycle 6 (one cycle equals 3 weeks)

Study Arms (8)

A/ Accelerated titration

EXPERIMENTAL

1mg of BAT6021

Drug: BAT6021

B/ Accelerated titration

EXPERIMENTAL

3mg of BAT6021

Drug: BAT6021

C/ Accelerated titration

EXPERIMENTAL

10mg of BAT6021

Drug: BAT6021

D/"standard 3 + 3"

EXPERIMENTAL

30mg of BAT6021

Drug: BAT6021

E/"standard 3 + 3"

EXPERIMENTAL

100mg of BAT6021

Drug: BAT6021

F/"standard 3 + 3"

EXPERIMENTAL

300mg of BAT6021

Drug: BAT6021

G/"standard 3 + 3"

EXPERIMENTAL

600mg of BAT6021

Drug: BAT6021

H/"standard 3 + 3"

EXPERIMENTAL

900mg of BAT6021

Drug: BAT6021

Interventions

BAT6021 DRUG

Ⅳ infusions

Also known as: Recombinant humanized monoclonal antibody against TIGIT injection

A/ Accelerated titration; B/ Accelerated titration; C/ Accelerated titration; D/"standard 3 + 3"; E/"standard 3 + 3"; F/"standard 3 + 3"; G/"standard 3 + 3"; H/"standard 3 + 3"

Eligibility Criteria

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

You may qualify if:

• Age: ≥18 years old, gender: male or female;
• The expected survival was assessed as at least 3 months;
• ECOG physical status score is required to be 0 or 1;
• 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;
• 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;
• 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.

You may not qualify if:

• Prior treatment with anti-TiGit monoclonal antibody or anti-TiGit active double antibody;
• 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;
• , 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;
• \. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first use of the investigational drug;
• \. 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;
• \. Pregnant or lactating women;
• \. Patients whose AE caused by previous antitumor therapy did not recover to CTCAE 5.0≤ 1, except hair loss;
• \. 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;
• \. 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;
• \. Those with a history of tissue or organ transplantation;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (3)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

Study Officials

• Yilong Wu, M.D, Ph.D

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

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: November 3, 2021
• First Posted: November 15, 2021
• Study Start: February 17, 2022
• Primary Completion: April 7, 2023
• Study Completion: April 7, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)