Trial Review

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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/NCT05509985




Registration number
NCT05509985
Ethics application status
Date submitted
15/08/2022
Date registered
22/08/2022
Date last updated
14/08/2023

Titles & IDs
Public title
A Phase 1 Study of ASKG315 in Patients With Advanced Solid Tumors
Scientific title
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
ASKG315-101
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
Other interventions - ASKG315

Experimental: ASKG315 - Single or multiple ascending dose of ASKG315


Other interventions: ASKG315
Injection with dose escalation stage of 3mg up to 45mg as well as dose expansion stage with recommended dose level from dose escalation stage.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety[DLTs?AEs?ECG]
Timepoint [1] 0 0
21days
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
21days
Secondary outcome [2] 0 0
Area under the concentration time curve (AUC)
Timepoint [2] 0 0
21days
Secondary outcome [3] 0 0
Cytokine
Timepoint [3] 0 0
21days
Secondary outcome [4] 0 0
Immunocyte
Timepoint [4] 0 0
21days

Eligibility
Key inclusion criteria
1. Signed informed consent form.

2. Male or female = 18 years of age (at the time signed consent is obtained).

3. Histologically or cytologically confirmed advanced malignant solid tumor that is
refractory to or intolerant of all standard therapy or for which no standard therapy
is available.

4. Measurable disease, per RECIST v1.1.

5. ECOG Performance Status of = 2.

6. Life expectancy of =3 months, in the opinion of the Investigator.

7. Adequate organ function defined.

8. Fertile patients must be willing to use effective contraceptive measures (hormonal or
barrier methods or abstinence, etc.) starting with the Screening visit through 90 days
+ 5 drug half-lives after the last dose of study treatment.

9. Negative serum pregnancy test for female patients within 7 days prior to the first
dose of the study drug or documentation of lack of childbearing potential.

10. Willing and able to participate in the trial and comply with all trial requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who meet any of the following criteria are not allowed to be enrolled:

1. Received any other investigational drug for treatment that is not commercially
available within 4 weeks prior to Cycle 1 Day 1.

2. Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy,
immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day
1.

3. Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning
elective surgery during the study period.

4. Received systemic glucocorticoid or other immunosuppressant treatment within 14 days
prior to C1D1.

5. Received immunomodulatory drugs, including but not limited to thymosin and interferon,
within 14 days prior to C1D1.

6. Received a live attenuated vaccine within 4 weeks prior to C1D1.

7. Received IL-2 or IL-15 therapy within 12 weeks prior to C1D1.

8. History of hematologic stem cell transplant or solid organ transplant.

9. Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade
= 1.

10. Cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms.

11. Have an active infection that currently requires intravenous anti-infection therapy.

12. A history of human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of
=350 cells/µL at screening. HIV positive patients must be receiving adequate
treatment.

13. If serological evidence of chronic hepatitis B virus infection (HBV), viral load below
the limit of quantification at screening.

14. If serological evidence of hepatitis C virus infection (HCV), should have completed
curative antiviral treatment and have HCV viral load below the limit of quantification
at screening.

15. Current clinically significant interstitial lung disease.

16. History of serious cardiovascular or cerebrovascular diseases.

17. Active or recurrent autoimmune diseases.

18. History of Grade = 3 Immune-Related Adverse Events (irAE) or Grade = 2
immunotherapy-associated myocarditis associated with treatment with an immune
checkpoint inhibitor.

19. Grade = 3 bleeding .

20. Symptomatic with uncontrolled ascites or pleural effusion.

21. History of a grade = 3 allergic reaction to protein drugs.

22. Known to have alcohol or drug dependence.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
9/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/09/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Blacktown Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AskGene Pharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the
safety, tolerability, PK and PD of ASKG315 as a single agent (Part 1) and in combination with
pembrolizumab (Part 2) in patients with advanced solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05509985
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara Hickingbottom, MD
Address 0 0
Ask-Gene Pharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
805-389-2956
Fax 0 0
Email 0 0
barbara.hickingbottom@ask-gene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05509985