Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05306444
Registration number
NCT05306444
Ethics application status
Date submitted
24/02/2022
Date registered
1/04/2022
Date last updated
13/12/2023
Titles & IDs
Public title
CLN-418 Study on Subjects With Advanced Solid Tumors
Query!
Scientific title
A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CLN-418 in Subjects With Advanced Solid Tumors
Query!
Secondary ID [1]
0
0
CLN-418-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - CLN-418
Experimental: CLN-418: Part 1 - Experimental Part 1: Dose escalation
Intravenous IV administrations of CLN-418 on Day 1 of each 21 day treatment cycle
Dose for cohorts to be confirmed following consultation and approval by Safety Review Committee
Experimental: CLN-418: Part 2 - Experimental Part 2: Dose Expansion
Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1
Treatment: Drugs: CLN-418
Intravenous (IV) administration
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of subjects with dose-limiting toxicity (DLT)
Query!
Assessment method [1]
0
0
Number of subjects who experienced DLT events during 21 days after first administration of CLN-418, divided by the number of DLT evaluable Subjects
Query!
Timepoint [1]
0
0
From Day 1 until day 21
Query!
Secondary outcome [1]
0
0
Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Query!
Assessment method [1]
0
0
Number of participants with Adverse Events (including vital signs, physical examinations, and abnormal laboratory parameters).
Query!
Timepoint [1]
0
0
From signing of Informed Consent Form (ICF) till 84 days after last dose
Query!
Secondary outcome [2]
0
0
Objective response rate, defined as the proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
Query!
Assessment method [2]
0
0
Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
Query!
Timepoint [2]
0
0
From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Query!
Secondary outcome [3]
0
0
Duration of response
Query!
Assessment method [3]
0
0
The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first.
Query!
Timepoint [3]
0
0
From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Query!
Secondary outcome [4]
0
0
Disease control rate
Query!
Assessment method [4]
0
0
The proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or stable disease (SD).
Query!
Timepoint [4]
0
0
From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Query!
Secondary outcome [5]
0
0
Duration of disease control
Query!
Assessment method [5]
0
0
The time from the date of start of treatment to the date of disease progression or death for subjects who had CR or PR or SD during treatment
Query!
Timepoint [5]
0
0
From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Query!
Secondary outcome [6]
0
0
Maximal tumor shrinkage
Query!
Assessment method [6]
0
0
The greatest tumor shrinkage achieved at any follow-up assessment
Query!
Timepoint [6]
0
0
From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Query!
Secondary outcome [7]
0
0
Pharmacokinetics Analysis - Serum Concentration
Query!
Assessment method [7]
0
0
Reporting of serum concentration of CLN-418
Query!
Timepoint [7]
0
0
Up to 84 days post last dose
Query!
Secondary outcome [8]
0
0
Anti-drug antibodies
Query!
Assessment method [8]
0
0
Measure of detectable Anti-drug antibody (ADA) and neutralizing antibodies in serum samples at specific study timepoints
Query!
Timepoint [8]
0
0
Up to 84 days post last dose
Query!
Secondary outcome [9]
0
0
Pharmacokinetics Analysis - Time Deviation
Query!
Assessment method [9]
0
0
Reporting time deviation data of CLN-418
Query!
Timepoint [9]
0
0
Up to 84 days post last dose
Query!
Eligibility
Key inclusion criteria
1. Willingness to sign a written informed consent document.
2. Male or female subject aged =18 years old at the time of screening.
3. Histologically or cytologically confirmed advanced solid tumors (e.g., breast cancer,
ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-small cell lung
cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelial carcinoma, head and
neck squamous cell carcinoma (HNSCC)), followed by dose-expansion cohorts (Part 2) of
subjects with advanced and/or metastatic non-small cell lung cancer (NSCLC),
triple-negative breast cancer (TNBC).or recurrent and progressed since last antitumor
therapy for which no alternative, curative standard therapy exists.
4. Adequate organ and bone marrow function.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Prior used anti-B7H4 and/or anti-4-1BB antibody treatment.
2. Immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior to first
dose of investigational product, any other anti-cancer therapy within 2 weeks prior to
first dose of investigational product.
3. Not yet recovered from surgery or (immune-related) toxicity related with previous
treatment.
4. Known history or active infection of hepatitis B or C.
5. History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related,
autoimmune hepatitis.
6. Known brain metastases or other central nervous system metastases that are either
symptomatic or untreated that require concurrent treatment.
7. Active infection that requires treatment with antibiotics or antiviral treatment
within 3 weeks prior to first dose of investigational product.
8. Known history of infection with human immunodeficiency virus or known acquired
immunodeficiency syndrome (AIDS).
9. Known autoimmune disease.
10. Clinically significant cardiac condition.
11. Pregnant or breastfeeding women.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/05/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2024
Query!
Actual
Query!
Sample size
Target
108
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
St George Private Hospital - Kogarah
Query!
Recruitment hospital [2]
0
0
Southern Medical Day Care Centre - Wollongong
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
2500 - Wollongong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
North Carolina
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Texas
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Cullinan Therapeutics Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Harbour BioMed US, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Study to evaluate the safety and tolerability of the study drug CLN-418, to determine the
maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05306444
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Meagan Sardinha
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1-617-410-4650
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05306444
Download to PDF