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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06656390




Registration number
NCT06656390
Ethics application status
Date submitted
20/10/2024
Date registered
24/10/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Scientific title
A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
ALK201-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALK201

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: ALK201
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 ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.
Timepoint [1] 0 0
Approximately 36 months
Secondary outcome [1] 0 0
To evaluate the pharmacokinetics (PK) of ALK201.
Timepoint [1] 0 0
Approximately 36 months
Secondary outcome [2] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [2] 0 0
Approximately 36 months
Secondary outcome [3] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [3] 0 0
Approximately 36 months
Secondary outcome [4] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [4] 0 0
Approximately 36 months
Secondary outcome [5] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [5] 0 0
Approximately 36 months
Secondary outcome [6] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [6] 0 0
Approximately 36 months
Secondary outcome [7] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [7] 0 0
Approximately 36 months
Secondary outcome [8] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [8] 0 0
Approximately 36 months
Secondary outcome [9] 0 0
To evaluate the pharmacokinetics (PK) of ALK201
Timepoint [9] 0 0
Approximately 36 months
Secondary outcome [10] 0 0
To evaluate the immunogenicity of ALK201.
Timepoint [10] 0 0
Approximately 36 months
Secondary outcome [11] 0 0
To evaluate the preliminary antitumor activity of ALK201
Timepoint [11] 0 0
Approximately 36 months
Secondary outcome [12] 0 0
To evaluate the preliminary antitumor activity of ALK201
Timepoint [12] 0 0
Approximately 36 months
Secondary outcome [13] 0 0
To evaluate the preliminary antitumor activity of ALK201
Timepoint [13] 0 0
Approximately 36 months
Secondary outcome [14] 0 0
To evaluate the preliminary antitumor activity of ALK201
Timepoint [14] 0 0
Approximately 36 months
Secondary outcome [15] 0 0
To evaluate the preliminary antitumor activity of ALK201
Timepoint [15] 0 0
Approximately 36 months
Secondary outcome [16] 0 0
To evaluate the biomarkers.
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
* Eastern Cooperative Oncology Group Performance Status (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 from the date of signing the ICF until at least 6 months after the last dose of the IP, 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
* Active or pre-existing autoimmune diseases that may relapse
* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage
* Allergies to any component of ALK201 or other monoclonal antibodies
* Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
* Combined with = Grade 2 stomatitis and/or nose bleeding at screening
* Vaccinated with live vaccines within 4 weeks prior to the first dose

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
24/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/04/2028
Actual
Sample size
Target
202
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Cancer Care Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Allink Biotherapeutics Co., 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
ALK Tang
Address 0 0
Country 0 0
Phone 0 0
+8618502921630
Fax 0 0
Email 0 0
xftang@allinkbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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/NCT06656390