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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05021120




Registration number
NCT05021120
Ethics application status
Date submitted
12/08/2021
Date registered
25/08/2021

Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours
Scientific title
A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours
Secondary ID [1] 0 0
AK127-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumours 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK127
Treatment: Drugs - AK104

Experimental: Intervention/treatment - Experimental


Treatment: Drugs: AK127
Subjects will receive AK127 by intravenous administration

Treatment: Drugs: AK104
After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Nature of Adverse Events (AEs)
Timepoint [1] 0 0
From the time of informed consent signed through to 90 days after end of treatment
Primary outcome [2] 0 0
Number of participants with a Dose Limiting Toxicity (DLT)
Timepoint [2] 0 0
Within the first six weeks of treatment
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics
Timepoint [5] 0 0
From first dose of treatment through to 90 days after end of treatment
Secondary outcome [6] 0 0
Maximum observed concentration (Cmax) of AK127 + AK104
Timepoint [6] 0 0
From first dose of treatment through to 90 days after end of treatment.
Secondary outcome [7] 0 0
Minimum observed concentration (Cmin) of AK127+AK104
Timepoint [7] 0 0
From first dose of treatment through to 90 days after end of treatment
Secondary outcome [8] 0 0
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Timepoint [8] 0 0
From first dose of treatment through to 90 days after end of treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2025
Actual
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ashford Cancer Centre Research - Adelaide
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment hospital [3] 0 0
Monash Health - Melbourne
Recruitment hospital [4] 0 0
Southside Cancer Care Centre - Sydney
Recruitment hospital [5] 0 0
The Kinghorn Cancer Centre, St Vincents Hospital Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akesobio Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Baiyong Li
Address 0 0
Country 0 0
Phone 0 0
+86 (0760) 8987 3999
Fax 0 0
Email 0 0
global.trials@akesobio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05021120