Assessment of Safety and Preliminary Clinical Efficacy with BAT6005 in Advanced Malignant Solid Tumors

NCT05116709 | Completed Phase 1

• 1 other identifier: BAT-6005-001-CR
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

This research design for center, increasing openness, dose and dose extension phase I clinical trials, research the main evaluation BAT6005 injection single drug in patients with advanced malignant solid tumors in the safety, tolerability and PK characteristics, to explore the maximum tolerated dose and preliminary antitumor efficacy, provide the basis for subsequent clinical trials recommended dose. Part I: single drug dose escalation study. Part TWO: dose extension study.

Conditions

Locally Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  AE that occur during the dose-limiting toxicity observation period and are considered to be at least possibly related to the drug under study.

  Complete the first cycle in 21 days

• Maximum Tolerated dose (MTD)

  The highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period.

  Complete the first cycle in 21 days

Secondary Outcomes (10)

• Maximum serum drug concentration(Cmax)Pharmacokinetic endpoint

  0-126days

• Maximum serum drug time(Tmax)

  0-126days

• Half-life period(t1/2)Pharmacokinetic endpoint

  0-126days

• Plasma clearance(CL)Pharmacokinetic endpoint

  0-126days

• Apparent Volume of Distribution（Vd）

  0-126days

Other Outcomes (5)

• Objective response rate (ORR)

  up to 17 cycles（each cycle is 21 days）

• Duration of remission (DOR)

  up to 17 cycles（each cycle is 21 days）

• Disease control rate (DCR)

  up to 17 cycles（each cycle is 21 days）

Study Arms (1)

BAT6005 single drug dose escalation study

EXPERIMENTAL

The whole is divided into two phases.The first stage: 10mg group, 30mg group, 100mg group using accelerated titration method to increase the dose.The second stage: 300mg group, 600mg group, 900mg group according to the standard "3+3" rule dose increase study.

Drug: BAT6005 injection

Interventions

BAT6005 injection DRUG

Six dose groups were set up, including 10mg (initial dose) group, 30mg group, 100mg group, 300mg group, 600mg group and 900mg group, respectively.

BAT6005 single drug dose escalation study

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 (Eastern Oncology Collaboration group) physical status score requirement: 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;
• Had received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to the first use of the study drug
• Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first use of the investigational drug;
• Received live/attenuated vaccine and mRNA vaccine within 4 weeks prior to screening or plan to receive live/attenuated vaccine and mRNA vaccine during the study period;
• Pregnant or lactating women;
• Patients whose AE caused by previous anti-tumor therapy did not recover to CTCAE 5.0≤ 1;
• Patients who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or who required elective surgery during the study period;
• Those with a history of tissue or organ transplantation;
• Patients with active infection prior to the first administration and currently requiring intravenous anti-infection therapy;
• Known history of human immunodeficiency virus (HIV) infection;
• active hepatitis B;
• Active HCV infected subjects
• Subjects with untreated or undergoing treatment for tuberculosis, including but not limited to tuberculosis; Patients who have been prescribed anti-tuberculosis therapy and confirmed by the investigator to have been cured may be included;
• The subject is known to have a history of severe allergy, or is known to have experienced grade ≥3 allergic reactions to macromolecular protein preparations/monoclonal antibodies in the past;
• Patients who have active autoimmune diseases, or have had autoimmune diseases with recurrence risk (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except patients with clinically stable autoimmune thyroid diseases and type I diabetes;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (2)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Location

Shanghai Oriental hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Jin Li

  Shanghai Oriental hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 11, 2021
• Study Start: November 12, 2021
• Primary Completion: January 10, 2024
• Study Completion: September 23, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)