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Trial registered on ANZCTR


Registration number
ACTRN12623001217695p
Ethics application status
Submitted, not yet approved
Date submitted
18/10/2023
Date registered
27/11/2023
Date last updated
27/11/2023
Date data sharing statement initially provided
27/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An open, phase Ia safety and dosing clinical trial evaluating IMD-101 in participants with advanced solid tumours.
Scientific title
An Open-Label Dose-Escalation Phase Ia Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of IMD-101 Injectable in Participants with Advanced Malignant Solid Tumours.
Secondary ID [1] 310811 0
AFB-105
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Advanced malignant solid tumours 331802 0
Condition category
Condition code
Cancer 328539 328539 0 0
Lung - Mesothelioma
Cancer 328540 328540 0 0
Lung - Non small cell
Cancer 328541 328541 0 0
Malignant melanoma
Cancer 328542 328542 0 0
Kidney
Cancer 328543 328543 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IMD-101 is given 20 microgram/kg as starting dose, every 2 weeks by intravenous infusion for 3 doses if safe to do so.
When it's safe to do, 20µg/kg, 40µg/kg, 80µg/kg, 120µg/kg, 180µg/kg, or 240µg/kg will be studied separately in order to establish a safe and recommended dose for further study.
Intervention code [1] 327222 0
Treatment: Drugs
Comparator / control treatment
Phase Ia has no comparator or "no control group" except the study drug itself, IMD-101 which is given 20 microgram/kg as starting dose, every 2 weeks by intravenous infusion for 3 doses if safe to do so. When 20 microgram is safe to move on to 40 microgram and other dose level step by step with the same duration, mode and safety monitoring.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336357 0
safety
Timepoint [1] 336357 0
Base line, Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 post-commencement of intervention.
Primary outcome [2] 336358 0
Safe and Recommended Dosing
Timepoint [2] 336358 0
Base line, Day 1, Day 8, Day 15, Day 22, Day 29, Day 43 post-commencement of intervention.
Secondary outcome [1] 427997 0
Pharmacokinetics
Timepoint [1] 427997 0
30 - 60 minutes before drug infusion;
from start of infusion: 30minutes, 1hour, 2hhours, 3hours, 4hours, 8hours, 24hours, 48hours and 72hours.

Eligibility
Key inclusion criteria
1. 18- years of age and older (incl.), male or female.
2. Participants with histologically or cytologically confirmed advanced malignant solid tumours, ie melanoma, non-small cell lung cancer (NSCLC), renal cell cancer, mesothelioma, bladder cancer with at least one evaluable tumour lesion by RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS (RECIST 1.1.), who failed standard of care treatment.
3. An Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
4. Survival expectancy > 3 months.
5. Adequate organ functions.
6. Eligible fertile participants (male and female) must agree to use a reliable contraceptive method (hormone, barrier method or abstinence) with their partners during the trial period and for at least 3 months after the last dose; female participants of childbearing age must have negative blood or urine pregnancy test within 7 days prior to enrollment. However, this requirement is not applicable to the females of non-child bearing potential who have been surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal females who have no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone level consistent with postmenopausal status.
7. Participants must provide informed consent to this study and voluntarily sign the informed consent form prior to the start of the trial. They also need to be able to comply with the study visit schedule and required assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receipt of anti-tumour treatments such as chemotherapy, radiotherapy, biotherapy, and endocrine therapy within 4 weeks prior to the first dose except the followings:
• Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the study drug;
• Oral fluorouracil and small-molecule targeted drugs within 2 weeks prior to the first dose of the study drug or within 5 half-lives of the drugs (whichever is longer);
2. Unlicensed investigational drugs or treatments within 4 weeks prior to the first dose of the study drug.
3. A participant who has previous treatment with IL-2 or IL-15 at investigator’s discretion.
4. Major organ surgery (excluding biopsy), significant trauma within 4 weeks prior to the first dose of the study drug, or the requirement to accept elective surgery during the trial.
5. Use of systemic corticosteroids (prednisone greater than 10 mg/day or an equivalent dose of similar drugs) or other immunosuppressive agents within 14 days prior to the first dose of the study drug except the following:
• Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids (e.g., to prevent contrast agent allergy).
6. Adverse reactions of prior anti-tumour therapy that have not yet reverted to Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade less than or equal to 1 (except for toxicities judged by the investigator to have no safety risk, e.g., alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilised by hormone replacement therapy, etc.).
7. Past history of allogeneic hematopoietic stem cell transplantation or organ transplantation.
8. Past history of serious hypersensitivity to IL-2 and the excipient (sodium thiosulfate) of the study drug.
9. Past history of hypotension.
10. Central nervous system metastases, meningeal metastases with clinical symptoms, or other evidence indicating the participant has uncontrolled central nervous system metastases or meningeal metastases so that the participant is assessed to be ineligible by the investigator.
11. Active COVID19 infection based on positive PCR test at the time screening at investigator’s discretion.

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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Listing and statistical analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
28/11/2025
Actual
Date of last data collection
Anticipated
28/01/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315054 0
Commercial sector/Industry
Name [1] 315054 0
Catalysis Therapeutics Pty Ltd
Country [1] 315054 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Catalysis Therapeutics Pty Ltd
Address
Level 9, 123 Epping Road, Macquarie Park, NSW 2113
Country
Australia
Secondary sponsor category [1] 317076 0
Charities/Societies/Foundations
Name [1] 317076 0
Cancer Care Foundation Limited
Address [1] 317076 0
Level 3, 533 Kingsway, Miranda NSW 2228
Country [1] 317076 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314008 0
Monash Health HREC
Ethics committee address [1] 314008 0
Ethics committee country [1] 314008 0
Australia
Date submitted for ethics approval [1] 314008 0
23/08/2023
Approval date [1] 314008 0
Ethics approval number [1] 314008 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130102 0
Prof Paul De Souza
Address 130102 0
Cancer Care Foundation Limited. Level 3, 533 Kingsway Miranda NSW 2228
Country 130102 0
Australia
Phone 130102 0
+61 2 85569303
Fax 130102 0
Email 130102 0
p.desouza@westernsydney.edu.au
Contact person for public queries
Name 130103 0
Chris Huang
Address 130103 0
Catalysis Therapeutics Pty Ltd. Level 9, 123 Epping Road, Macquarie Park, NSW 2113
Country 130103 0
Australia
Phone 130103 0
+61 2 88757818
Fax 130103 0
Email 130103 0
chrishuang@affinitybiopharma.com
Contact person for scientific queries
Name 130104 0
Paul De Souza
Address 130104 0
Cancer Care Foundation Limited. Level 3, 533 Kingsway Miranda NSW 2228
Country 130104 0
Australia
Phone 130104 0
+61 2 85569303
Fax 130104 0
Email 130104 0
p.desouza@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
for confidentiality reasons, individual participant data will not be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.