None listed
Conditions
Brief summary
This study is evaluating the safety, dosing, absorption and distribution of IMD-101, an innovative anti-cancer immunotherapy drug, in patients with advanced malignant solid tumours. Who is it for? You may be eligible for this study if you are an adult with histologically or cytologically confirmed advanced malignant solid tumours, including melanoma, non-small cell lung cancer (NSCLC), renal cell cancer, mesothelioma, and bladder cancer, and have failed standard of care treatment. IMD-101 is given 20 microgram/kg by intravenous infusion every 2 weeks for 3 times. When it's safe to do, 40 microgram, 80 microgram, 120 microgram, 180 microgram, or 240 microgram will be tested sequentially. Participants will also be asked to attend to visits for up to 6 weeks following commencement of IMD-101 for blood and urine tests, and physical examinations.
Interventions
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.
Sponsors
Catalysis Therapeutics Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed