A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

NCT ID: NCT05021120

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2025-04-01

Brief Summary

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.

Detailed Description

This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.

Conditions

Advanced or Metastatic Solid Tumours

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention/treatment

Experimental

Group Type: EXPERIMENTAL

AK127

Intervention Type: DRUG

Subjects will receive AK127 by intravenous administration

AK104

Intervention Type: DRUG

After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration

Interventions

AK127

Subjects will receive AK127 by intravenous administration

Intervention Type: DRUG

AK104

After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written and signed informed consent

2. In Phase 1a, patients with relapsed or refractory advanced solid malignancies

3. In Phase 1b, patients must have received no more than three prior lines of systemic therapy

4. Subject must have at least one measurable lesion according to RECIST Version1.1.

5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

6. Available archived or fresh tumor tissue

7. Adequate organ function.

8. For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.

9. Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product.

Exclusion Criteria

1. History of severe hypersensitivity reactions to other mAbs.

2. Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.

3. Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy

4. Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment

5. Any major surgery within 4 weeks prior to the first dose of treatment

6. Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.

7. Active or prior documented inflammatory bowel disease

8. History of organ transplant.

9. History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.

10. Known active hepatitis B or C infections or history of HIV.

11. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.

12. Patients with severe heart and lung dysfunction.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akesobio Australia Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ashford Cancer Centre Research

Adelaide, , Australia

Austin Health

Melbourne, , Australia

Monash Health

Melbourne, , Australia

Southside Cancer Care Centre

Sydney, , Australia

The Kinghorn Cancer Centre, St Vincents Hospital Sydney

Sydney, , Australia

Countries

Australia

Other Identifiers

AK127-101

Identifier Type: -

Identifier Source: org_study_id