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

NCT05109650 | Terminated Phase 1

• 1 other identifier: BAT-6026-002-CR
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity(DLT)

  A DLT is defined as a toxicity occurring during the DLT observation period. Events clearly associated with the underlying disease, disease progression, a concomitant medication, or comorbidity should be excepted, and it should be considered to be at least possibly related to study drug as defined below Grade 5 toxicity; Grade 4 anaemia; Grade 4 thrombocytopenia lasting ≥ 7 days ; Grade 3 thrombocytopenia if associated with clinically significant bleeding (≥ Grade 2 haemorrhage) or with requirement of transfusion of platelets; Grade 4 neutropenia for ≥ 7 days ; ≥ Grade 3 neutropenia associated with infection or febrile neutropenia

  the first cycle of 21 days for monotherapy and the second cycle of another 21 days for combination therapy

• Serious adverse event（SAE)

  Any SAE that is judged by the PI or designee to be related to the study medication must be reported regardless of the amount of time since the last dose received. Follow-up information collected for any initial report of an SAE must also be reported to the Sponsor within 24 hours of receipt by the PI or designee.

  Adverse events will be collected from the time of informed consent to 90 days after the last dose or until the initiation of a new cancer treatment.

Study Arms (6)

0.1mg/kg of BAT6026 + 300mg of BAT1308

EXPERIMENTAL

0.1mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 0.1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Drug: BAT6026; Drug: BAT1308

0.3mg/kg of BAT6026 + 300mg of BAT1308

EXPERIMENTAL

0.3mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 0.3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Drug: BAT6026; Drug: BAT1308

1mg/kg of BAT6026 + 300mg of BAT1308

EXPERIMENTAL

1mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 1mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Drug: BAT6026; Drug: BAT1308

3mg/kg of BAT6026 + 300mg of BAT1308

EXPERIMENTAL

3mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 3mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Drug: BAT6026; Drug: BAT1308

6mg/kg of BAT6026 + 300mg of BAT1308

EXPERIMENTAL

6mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 6mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Drug: BAT6026; Drug: BAT1308

10mg/kg of BAT6026 + 300mg of BAT1308

EXPERIMENTAL

10mg/kg of BAT6026 Ⅳ infusions at cycle 1(monotherapy), and 10mg/kg of BAT6026 IV infusions + 300mg of BAT1308 IV infusions(combination therapy) from cycle 2 until end of treatment

Drug: BAT6026; Drug: BAT1308

Interventions

BAT6026 DRUG

IV infusions

Also known as: Recombinant Anti-OX40 Antibody Solution for Injection

0.1mg/kg of BAT6026 + 300mg of BAT1308; 0.3mg/kg of BAT6026 + 300mg of BAT1308; 10mg/kg of BAT6026 + 300mg of BAT1308; 1mg/kg of BAT6026 + 300mg of BAT1308; 3mg/kg of BAT6026 + 300mg of BAT1308; 6mg/kg of BAT6026 + 300mg of BAT1308

BAT1308 DRUG

Ⅳ infusions

Also known as: Recombinant Anti-PD-1 Antibody Solution for Injection

0.1mg/kg of BAT6026 + 300mg of BAT1308; 0.3mg/kg of BAT6026 + 300mg of BAT1308; 10mg/kg of BAT6026 + 300mg of BAT1308; 1mg/kg of BAT6026 + 300mg of BAT1308; 3mg/kg of BAT6026 + 300mg of BAT1308; 6mg/kg of BAT6026 + 300mg of BAT1308

Eligibility Criteria

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

You may qualify if:

• Subjects able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
• \. Male or female, age ≥ 18 years.
• \. Life expectancy ≥3 months.
• \. ECOG performance status ≤1.
• \. Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumours that are refractory to standard therapy, or for which no standard therapy exists.
• \. Has measurable disease per RECIST v1.1. that was not in a prior radiation or other locally treated area, unless imaging-based progression has been clearly documented following radiation or other local therapy

You may not qualify if:

• \. Pregnant or nursing females.
• \. Receiving concurrent anti-cancer therapy or investigational therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy).
• \. Any remaining AEs \> Grade 1 from prior anti-tumour treatment as per CTCAE v5.0, with exception of alopecia.
• Subjects with primacy central nervous system (CNS) malignancy or symptomatic CNS metastases are not allowed. Subjects with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as ≥4 weeks of stable neurologic function following CNS-directed therapy, and no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to the first dose of study drug. Subjects who are receiving prednisone ≤ 10mg or equivalent steroid therapies and have a stable CNS symptom is allowed.
• \. Subjects who have had major surgery within the 28-days from screening. If surgical procedure occurs \> 28 days, they must have recovered adequately from the toxicity and/or complications from the intervention before the first dose of study drug.
• \. Subjects with a history of tissue or organ transplantation.
• \. Subjects who have had severe infection deemed clinically significant per Investigator within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.
• \. History of human immunodeficiency virus (HIV) infection or history of autoimmune diseases.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (3)

St George Private Hospital

Kogarah, Australia

Location

Blacktown Cancer and Haematology Centre

Sydney, Australia

Location

Scientia Clinical Research Limited

Sydney, Australia

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Prachi Bhave, M.D, Ph.D

  Scientia Clinical Research Ltd

  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 27, 2021
• First Posted: November 5, 2021
• Study Start: February 28, 2022
• Primary Completion: March 23, 2023
• Study Completion: February 2, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)