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

NCT05021120 | Completed Early Phase 1 DMC

• 1 other identifier: AK127-101
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumours

Outcome Measures

Primary Outcomes (2)

• Incidence and Nature of Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  From the time of informed consent signed through to 90 days after end of treatment

• Number of participants with a Dose Limiting Toxicity (DLT)

  DLTs will be assessed during the first treatment cycle and assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.

  Within the first six weeks of treatment

Secondary Outcomes (8)

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics

  From first dose of treatment through to 90 days after end of treatment

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

Experimental

Drug: AK127; Drug: AK104

Interventions

AK127 DRUG

Subjects will receive AK127 by intravenous administration

Intervention/treatment

AK104 DRUG

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

Intervention/treatment

Eligibility Criteria

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

You may qualify if:

• Written and signed informed consent
• In Phase 1a, patients with relapsed or refractory advanced solid malignancies
• In Phase 1b, patients must have received no more than three prior lines of systemic therapy
• Subject must have at least one measurable lesion according to RECIST Version1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Available archived or fresh tumor tissue
• Adequate organ function.
• For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
• 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.

You may not qualify if:

• History of severe hypersensitivity reactions to other mAbs.
• Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
• Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
• 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
• Any major surgery within 4 weeks prior to the first dose of treatment
• Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
• Active or prior documented inflammatory bowel disease
• History of organ transplant.
• History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
• Known active hepatitis B or C infections or history of HIV.
• Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
• Patients with severe heart and lung dysfunction.

Sponsors & Collaborators

• Akesobio Australia Pty Ltd: lead

Study Sites (5)

Ashford Cancer Centre Research

Adelaide, Australia

Location

Austin Health

Melbourne, Australia

Location

Monash Health

Melbourne, Australia

Location

Southside Cancer Care Centre

Sydney, Australia

Location

The Kinghorn Cancer Centre, St Vincents Hospital Sydney

Sydney, Australia

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 25, 2021
• Study Start: October 12, 2021
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)