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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06707610




Registration number
NCT06707610
Ethics application status
Date submitted
25/11/2024
Date registered
27/11/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
Scientific title
A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
Secondary ID [1] 0 0
ALK202-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALK202

Experimental: Part A: Dose-escalation Phase Part B: Dose-expansion Phase - A dose-escalation study to determine the MTD and the subsequent doses for dose expansion study (Part B). A dose-expansion study which will enroll the select indications.


Treatment: Drugs: ALK202
Administered intravenously, once every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 for subsequent clinical studies.
Assessment method [1] 0 0
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Timepoint [1] 0 0
Approximately 36 months
Secondary outcome [1] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [1] 0 0
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)
Timepoint [1] 0 0
Approximately 36 months
Secondary outcome [2] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [2] 0 0
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
Timepoint [2] 0 0
Approximately 36 months
Secondary outcome [3] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [3] 0 0
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
Timepoint [3] 0 0
Approximately 36 months
Secondary outcome [4] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [4] 0 0
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Timepoint [4] 0 0
Approximately 36 months
Secondary outcome [5] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [5] 0 0
PK parameters after single and multiple doses: trough Concentration(Ctrough)
Timepoint [5] 0 0
Approximately 36 months
Secondary outcome [6] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [6] 0 0
PK parameters after single and multiple doses: Clearance(CL)
Timepoint [6] 0 0
Approximately 36 months
Secondary outcome [7] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [7] 0 0
PK parameters after single and multiple doses: apparent Distribution Volume(Vd)
Timepoint [7] 0 0
Approximately 36 months
Secondary outcome [8] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [8] 0 0
PK parameters after single and multiple doses: steady-state apparent distribution volume (Vss)
Timepoint [8] 0 0
Approximately 36 months
Secondary outcome [9] 0 0
To evaluate the pharmacokinetics (PK) of ALK202
Assessment method [9] 0 0
PK parameters after single and multiple doses: terminal half-life (t1/2)
Timepoint [9] 0 0
Approximately 36 months
Secondary outcome [10] 0 0
To evaluate the immunogenicity of ALK202
Assessment method [10] 0 0
The generation of anti-drug antibodies (ADAs)
Timepoint [10] 0 0
Approximately 36 months
Secondary outcome [11] 0 0
To evaluate the preliminary antitumor activity of ALK202
Assessment method [11] 0 0
Objective Response Rate (ORR)
Timepoint [11] 0 0
Approximately 36 months
Secondary outcome [12] 0 0
To evaluate the preliminary antitumor activity of ALK202
Assessment method [12] 0 0
Duration of Response (DOR)
Timepoint [12] 0 0
Approximately 36 months
Secondary outcome [13] 0 0
To evaluate the preliminary antitumor activity of ALK202
Assessment method [13] 0 0
Disease Control Rate (DCR)
Timepoint [13] 0 0
Approximately 36 months
Secondary outcome [14] 0 0
To evaluate the preliminary antitumor activity of ALK202
Assessment method [14] 0 0
Progression-Free Survival (PFS)
Timepoint [14] 0 0
Approximately 36 months
Secondary outcome [15] 0 0
To evaluate the preliminary antitumor activity of ALK202
Assessment method [15] 0 0
Overall Survival (OS)
Timepoint [15] 0 0
Approximately 36 months
Secondary outcome [16] 0 0
To evaluate the biomarkers
Assessment method [16] 0 0
To explore the correlation between biomarkers (EGFR/c-MET) and the efficacy and other clinical outcomes/parameters of ALK202
Timepoint [16] 0 0
Approximately 36 months

Eligibility
Key inclusion criteria
* Men and women =18 and =75 years old on the day of signing the ICF
* At least 1 measurable lesion per RECIST v1.1
* Expected survival =3 months
* ECOG PS score of 0 or 1
* Adequate organ function
* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received organ transplant or hematopoietic stem cell transplant previously
* Vaccinated with live vaccines within 4 weeks prior to the first dose
* Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
* Pregnant or lactating women
* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
* Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
10/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
234
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [2] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Allink Biotherapeutics Co., Ltd.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shuntong Duan
Address 0 0
Country 0 0
Phone 0 0
8618005141727
Email 0 0
stduan@allinkbio.com
Contact person for scientific queries

Data sharing statement


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/NCT06707610