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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
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
Secondary ID [1] 0 0
CLN-418-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with dose-limiting toxicity (DLT)
Timepoint [1] 0 0
From Day 1 until day 21
Secondary outcome [1] 0 0
Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Timepoint [1] 0 0
From signing of Informed Consent Form (ICF) till 84 days after last dose
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
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
Secondary outcome [3] 0 0
Duration of response
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
Secondary outcome [4] 0 0
Disease control rate
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.
Secondary outcome [5] 0 0
Duration of disease control
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.
Secondary outcome [6] 0 0
Maximal tumor shrinkage
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
Secondary outcome [7] 0 0
Pharmacokinetics Analysis - Serum Concentration
Timepoint [7] 0 0
Up to 84 days post last dose
Secondary outcome [8] 0 0
Anti-drug antibodies
Timepoint [8] 0 0
Up to 84 days post last dose
Secondary outcome [9] 0 0
Pharmacokinetics Analysis - Time Deviation
Timepoint [9] 0 0
Up to 84 days post last dose

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
12/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cullinan Therapeutics Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Harbour BioMed US, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05306444
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
Meagan Sardinha
Address 0 0
Country 0 0
Phone 0 0
+1-617-410-4650
Fax 0 0
Email 0 0
ClinOps@cullinanoncology.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05306444