Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06730386




Registration number
NCT06730386
Ethics application status
Date submitted
9/12/2024
Date registered
12/12/2024
Date last updated
12/12/2024

Titles & IDs
Public title
A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors
Scientific title
A First-in-human, Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK138D1 in the Treatment of Advanced Solid Tumors
Secondary ID [1] 0 0
AK138D1-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK138D1

Experimental: AK138D1 - AK138D1 will be administered in pre-specified dose levels.


Treatment: Drugs: AK138D1
Enrolled subjects will receive intravenous infusion (IV) of AK138D1 according to the dosing regimen specified in their cohort.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AEs
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Dose-limiting toxicity (DLT)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Cmax and Cmin of AK138D1
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Anti-drug antibodies (ADA)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Time to response (TTR) assessed by the investigator per RECIST v1.1
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
1. The subject must sign the written informed consent form (ICF) voluntarily;
2. At enrollment, aged = 18 to = 75 years, both males and females are eligible;
3. ECOG performance status score of 0 or 1;
4. Has a life expectancy of = 3 months;
5. Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;
6. At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
7. Adequate organ function.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
2. Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
3. Presence of active central nervous system (CNS) metastases.
4. Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;
5. Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
6. Untreated subjects with active hepatitis B (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;
7. Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
8. Active syphilis infection;
9. Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
10. Other reasons for ineligibility as evaluated by the investigator.

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
26/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akeso
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
Wenting Li, MD
Address 0 0
Country 0 0
Phone 0 0
+86-18116403289
Fax 0 0
Email 0 0
wenting01.li@akesobio.com
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT06730386