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Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients

NCT05109650 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-08-12

No results posted yet for this study

Summary

This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40 monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects with advanced solid tumours. After a screening period of up to 28 days, qualified subjects will be enrolled to receive their assigned dose regimen until disease progression or intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study, whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on treatment in the absence of disease progression for more than 1 year may continue to receive study drug for the next cycle at the maximum of 2 years.

Conditions

  • Advanced Solid Tumour

Interventions

DRUG

BAT6026

IV infusions

DRUG

BAT1308

Ⅳ infusions

Sponsors & Collaborators

Principal Investigators

  • Prachi Bhave, M.D, Ph.D · Scientia Clinical Research Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-03-23
Completion
2024-02-02

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109650 on ClinicalTrials.gov