Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China

NCT05105971 | Completed Phase 1

• 1 other identifier: BAT-6026-001-CR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

the main purpose:

• Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability
• Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules. Secondary purpose:
• Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug;
• Evaluate the immunogenicity of BAT6026 injection;
• Evaluate the pharmacodynamic properties of BAT6026 injection;
• Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• dose-limiting toxicity (DLT)

  safety and tolerability endpoint

  3 weeks

• maximum tolerated dose (MTD)

  maximum tolerated dose (MTD)

  3 weeks

Secondary Outcomes (1)

• Maximum serum drug concentration（Cmax)

  no more than 52 weeks

Study Arms (8)

BAT6026 0.01mg/kg

EXPERIMENTAL

BAT6026 0.01mg/kg,intervenous infusion,sample size 1

Drug: BAT6026

BAT6026 0.03mg/kg

EXPERIMENTAL

BAT6026 0.03mg/kg,intervenous infusion,sample size 1

Drug: BAT6026

BAT6026 0.1mg/kg

EXPERIMENTAL

BAT6026 0.1mg/kg,intervenous infusion,sample size 3\~6

Drug: BAT6026

BAT6026 0.3mg/kg

EXPERIMENTAL

BAT6026 0.3mg/kg,intervenous infusion,sample size 3\~6

Drug: BAT6026

BAT6026 1mg/kg

EXPERIMENTAL

BAT6026 1mg/kg,intervenous infusion,sample size 3\~6

Drug: BAT6026

BAT6026 3mg/kg

EXPERIMENTAL

BAT6026 3mg/kg,intervenous infusion,sample size 3\~6

Drug: BAT6026

BAT6026 6mg/kg

EXPERIMENTAL

BAT6026 6mg/kg,intervenous infusion,sample size 3\~6

Drug: BAT6026

Amplification group

EXPERIMENTAL

BAT6026 10mg/kg,intervenous infusion,sample size 3\~6

Drug: BAT6026

Interventions

BAT6026 DRUG

Phase 1 dose titration study from BAT6026 0.01mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result

Also known as: anti-OX40 monoclonal antibody

Amplification group; BAT6026 0.01mg/kg; BAT6026 0.03mg/kg; BAT6026 0.1mg/kg; BAT6026 0.3mg/kg; BAT6026 1mg/kg; BAT6026 3mg/kg; BAT6026 6mg/kg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years of age ≤75 years of age, gender: men and women are not limited;
• The investigator estimates that the expected survival period is at least 3 months;
• The Eastern Cooperative Oncology Group (ECOG) performance status scoring requirement is 0 or 1;
• Patients with locally advanced or metastatic solid tumors diagnosed by pathology who have failed standard treatment or have no effective treatment methods (refer to CSCO guidelines in 2021);
• According to the tumor efficacy evaluation standard RECIST 1.1, there must be at least one measurable tumor lesion during the dose expansion stage;

You may not qualify if:

• Have received anti-OX40 monoclonal antibody or double-antibody drug therapy with anti-OX40 activity in the past;
• It is receiving or expected to receive other anti-tumor treatments during the first study drug administration, including but not limited to chemotherapy, radiotherapy, immunotherapy, hormone therapy (except alternative therapies), targeted therapy, biological therapy, and anti-tumor effects Chinese patent medicine, etc.;
• Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time, except for the following items:? Nitrosourea or Mitomycin C is within 6 weeks before the first use of the study drug;? Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or 5 half-lives of the drug (whichever is longer);? Chinese medicine with anti-tumor indications should be within 2 weeks before the first use of the study drug;
• Clinical investigators who are participating in this study or who have participated in experimental drugs or medical devices within 4 weeks before the first administration of this study cannot be included;
• Have been vaccinated within 4 weeks before the first administration or plan to vaccinate live/attenuated vaccines and mRNA vaccines during the study period;
• Pregnant or lactating women;
• Patients whose AEs caused by the original anti-tumor therapy within 4 weeks before the first administration of the study drug did not return to CTCAE 5.0≤1 (except for hair loss and fatigue ≤2); previous irAE ≥3 or any level of irAE Those who have terminated immunotherapy;
• Major surgery (defined as grade 3 and 4 surgery) within 4 weeks before the first administration;
• Those who have a history of tissue or organ transplantation;
• Subjects who have had serious infections within 4 weeks before the first administration, including but not limited to infectious complications that require hospitalization, bacteremia, severe pneumonia, etc.; subjects with active infections before the first administration are excluded By;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Study Officials

• Li Zhang, M.D, Ph.D

  Sun Yat-sen University

  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: October 24, 2021
• First Posted: November 3, 2021
• Study Start: December 23, 2021
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (1)