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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06929663




Registration number
NCT06929663
Ethics application status
Date submitted
16/03/2025
Date registered
16/04/2025
Date last updated
17/07/2025

Titles & IDs
Public title
A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors
Scientific title
A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of AK146D1 for Injection, an Anti-Trop2/Nectin4 Bispecific Antibody-drug Conjugate, in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AK146D1-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AK146D1 for injection

Experimental: AK146D1 for injection - AK146D1 for injection will be administered in pre-specified dose levels


Treatment: Drugs: AK146D1 for injection
AK146D1 for injection is an anti-Trop2/Nectin4 bispecific antibody-drug conjugate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose limiting toxicities (DLTs)
Timepoint [1] 0 0
During the first 3 weeks of treatment.
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
Timepoint [2] 0 0
From the time of informed consent signed through 90 days after the last dose of study drug
Secondary outcome [1] 0 0
Serum PK concentration of AK146D1
Timepoint [1] 0 0
From pre-dose to the end of the last dose, an average of 6 months.
Secondary outcome [2] 0 0
Anti-drug antibodies (ADA)
Timepoint [2] 0 0
From pre-dose to 90 days post end of treatment
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 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. Be able to understand and voluntarily sign the written informed consent form.
2. Aged of = 18 years and =75 years.
3. ECOG PS 0 or 1.
4. The expected lifespan is =3 months.
5. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
6. At least one measurable lesion according to RECIST v1.1.
7. Have sufficient organ function.
8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Having other active malignancies within 3 years.
2. Currently participating in another interventional clinical study.
3. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
4. Having received any treatment targeting Trop2 or Nectin4 or any treatment with topoisomerase I inhibitor agents.
5. Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
7. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
8. Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
9. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
10. Known to be positive for HIV and other infections.
11. Previous history of severe hypersensitivity reactions.
12. Live attenuated vaccines were received within 4 weeks.
13. Subjects with a history of mental illness and incapacitated or limited capacity.
14. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.

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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/05/2027
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

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
Hui Gan
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ting Liu
Address 0 0
Country 0 0
Phone 0 0
+86(0760)8987 3999
Fax 0 0
Email 0 0
[email protected]
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/NCT06929663