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

EARLY_PHASE1RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-10-12

Primary completion: 2025-01-10

Study completion finish: 2025-04-07

Study type

TREATMENT

Phase

EARLY_PHASE1

Trial ID

NCT05021120

Intervention or treatment

DRUG: AK127

DRUG: AK104

Conditions

• Advanced or Metastatic Solid Tumours

Image related to Advanced or Metastatic Solid Tumours

Condition: Advanced or Metastatic Solid Tumours
DRUG: AK127 and other drugs
Melbourne, Not Specified, Australia and more
Sponsor: Akesobio Australia Pty Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Health

Research sites nearby

Select from list below to view details:

Austin Health
Melbourne, Not Specified, Australia
Ashford Cancer Centre Research
Adelaide, Not Specified, Australia
Monash Health
Melbourne, Not Specified, Australia
Southside Cancer Care Centre
Sydney, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intervention/treatment Experimental	DRUG: AK127 Subjects will receive AK127 by intravenous administration

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Objective response rate (ORR)	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.	Up to 2 years
Disease control rate (DCR)	Progression-free survival is defined as the time from the start of treatment with AK127 + AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Progression-free survival (PFS)	Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Overall survival (OS)	Overall survival is defined as the time from the start of treatment until death due to any cause.	Up to 2 years
Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics	The endpoints for assessment of PK including serum concentrations of AK127+AK104 at different timepoints after treatment administration.	From first dose of treatment through to 90 days after end of treatment
Maximum observed concentration (Cmax) of AK127 + AK104	The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.	From first dose of treatment through to 90 days after end of treatment.
Minimum observed concentration (Cmin) of AK127+AK104	The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.	From first dose of treatment through to 90 days after end of treatment
Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of AK127+AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).	From first dose of treatment through to 90 days after end of treatment

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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