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Trial registered on ANZCTR


Registration number
ACTRN12623000358640
Ethics application status
Approved
Date submitted
17/02/2023
Date registered
6/04/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
6/04/2023
Date results information initially provided
1/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Part A, B and D: A Study of SGR-1505 in Healthy Volunteer Participants
Scientific title
Part A, B and D: A 4-Part Dose-Escalation, Food Effect, And Drug-Drug Interaction Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of SGR-1505 In Healthy Volunteers
Secondary ID [1] 308772 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL) 328716 0
Condition category
Condition code
Cancer 325726 325726 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SGR-1505 is an oral small molecule inhibitor of mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) and is intended for the treatment of mature non-Hodgkin B-cell lymphomas, with the primary indication in activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL).
Investigational Product: SGR-1505
Dosage Formulation: Tablet
Route of Administration: Oral
Study consists of 3 parts:
Part A: study will evaluate the safety, tolerability, and PK of single ascending oral doses (SAD) of SGR-1505. Participants will enroll into each of the 6 SAD cohorts sequentially. All participants in the cohort will be evaluated for safety and tolerability before starting higher doses.
Cohort A1: Participants will receive a single dose of 25 mg of SGR-1505 on Day 1
Cohort A2: Participants will receive a single dose of 50 mg of SGR-1505 on Day 1
Cohort A3: Participants will receive a single dose of 100 mg of SGR-1505 on Day 1
Cohort A4: Participants will receive a single dose of 150 mg of SGR-1505 on Day 1
Cohort A5: Participants will receive a single dose of 200 mg of SGR-1505 on Day 1
Cohort A6: Participants will receive a single dose of 300 mg of SGR-1505 on Day 1
Part B of this study will evaluate multiple ascending oral doses (MAD) up to 10 days. Six participants will enroll into each of the 3 MAD cohorts. All participants in the cohort will be evaluated for safety and tolerability prior to initiating higher doses.
Part B will commence once the safety and tolerability of the 100 mg dose in Part A is established.
Cohort B1: Participants will receive once daily dose of 75 mg of SGR-1505 for 10 days.
Cohort B2: Participants will receive once daily dose of 150 mg of SGR-1505 for 10 days.
Cohort B3: Participants will receive once daily dose of 300 mg of SGR-1505 for 10 days.
Part D of this study will evaluate the effect of posaconazole (a CYP3A inhibitor) on the PK profile of SGR-1505. 200 mg SGR-1505 will be administered with a low dose of an antifungal drug called posaconazole in the fasted state.
Cohort D1: Participants will receive orally single dose of 200 mg of SGR-1505 on Day 1 and 18.
Participants will receive once daily single dose of 100 mg posaconazole on Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18, Day 19, Day 20, Day 21, Day 22, Day 23, Day 24, Day 25, Day 26.
Part D will start after the completion of cohort 5 in Part A
The subjects are domiciled at the Phase 1 unit and dosing administered and verified by the staff for all parts of the study.
Intervention code [1] 325222 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333577 0
To assess the safety and tolerability of SGR-1505 following single and repeat doses in healthy participants.
To be assessed by monitoring
- The Incidence and severity of adverse events (AEs) . An assessment of AE severity will be performed according to the United States Food and Drug Administration (USFDA) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
- Clinical laboratory findings (Clinical Chemistry, Hematology, Coagulation): blood sample collection and analysis by pathology lab
- 12-lead Electrocardiogram (ECG)
- Vital sign measurements of (systolic/diastolic blood pressure - pulse rate -; body temperature - and respiratory rate using standard manual or electronic clinical procedures.
Timepoint [1] 333577 0
Part A: Adverse events (AE) will be monitored once daily from baseline to Day 10 post-dose administration
Part B: Adverse events (AE) will be monitored once daily from baseline to Day 11 post-dose administration
Part D: Adverse events (AE) will be monitored once daily from baseline to Day 27 post-dose administration
Secondary outcome [1] 417580 0
Part D: To assess the effect of posaconazole on the PK of SGR-1505 in healthy participants
Differences in PK parameters for SGR-1505 administered alone relative to the PK after multiple doses of posaconazole, includies area under the plasma drug concentration versus time curve (AUC0-t, AUC0-inf), maximum observed plasma drug concentration (Cmax), time to maximum observed plasma drug concentration (tmax), and apparent terminal half-life (t1/2).
Blood samples will be collected for PK analysis.
Timepoint [1] 417580 0
Part D: Day 1: predose, 30 minutes post-dose, 1, 2, 4, 8, hours post dose. Then once daily Day 2-8. Day 18: predose, 30 minutes post-dose, 1, 2, 4, 8, hours post dose. Then once daily - on Day 19-27
Secondary outcome [2] 417581 0
Part B: To assess dose proportionality of SGR-1505
Plasma sample will be collected for PK assessment.
AUC0-t, AUC0-8, and Cmax following single dose and AUC0-tau, AUC0-8,ss, and Cmax,ss following multiple doses for the assessment of dose proportionality.
Timepoint [2] 417581 0
Part B: predose, 30 minutes post-dose, 1, 2, 4, 8, hours post dose. Then once daily before study drug administration on Day 2-9. Day 10: predose, 30 minutes post-dose, 1, 2, 4, 8, and 24 hours post dose.

Eligibility
Key inclusion criteria
1. Male or female participant must be between 18 and 60 years of age (inclusive) at the time of signing the informed consent form (ICF).
2. Participant must understand and sign an ICF prior to any study-related assessments/procedures being conducted.
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive) with a minimum body weight of 45 kg.
4. Participant must be able to comply with the study protocol and adhere to the study visit schedule in the Investigator’s judgment.
5. Participant must be in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and upon check-in as assessed by the Investigator (or designee), as applicable.
6. Women of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose of study treatment (during screening), and a negative serum or urine pregnancy test within 24 hours of the first dose of study treatment.
7. Men and women of childbearing potential must agree to use highly effective contraception and refrain from egg or sperm donation throughout the study (from signing of the ICF and for 90 days after the last dose of study drug).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diseases or conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
2. Use of any investigational drug within 30 days, or 5 half-lives, whichever is longer, prior to the planned first drug administration.
3. Participant with any clinically significant active symptoms at time of enrollment.
4. Participant has a known allergy to SGR-1505, components of SGR-1505, or an allergy to Posaconazole for participants considered for enrollment into the DDI cohort.
5. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inhibitor or inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
6. Participants with known history of Gilbert’s syndrome.
7. Participants with chronic jaundice and/or a known familial history of jaundice.
8. Participants who are pregnant, breastfeeding or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
9. Participant has any condition, including clinically significant acute bacterial, viral, or fungal infection which places the participant at unacceptable risk if he/she were to participate in the study.

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 design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2023
Actual
17/04/2023
Date of last participant enrolment
Anticipated
31/10/2023
Actual
18/10/2023
Date of last data collection
Anticipated
30/11/2023
Actual
26/10/2023
Sample size
Target
66
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23871 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 39328 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312993 0
Commercial sector/Industry
Name [1] 312993 0
Schrödinger, Inc.
Country [1] 312993 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schrödinger, Inc
Address
1540 Broadway, 24th Floor New York, NY 10036
Country
United States of America
Secondary sponsor category [1] 314676 0
None
Name [1] 314676 0
Address [1] 314676 0
Country [1] 314676 0
Other collaborator category [1] 282526 0
Commercial sector/Industry
Name [1] 282526 0
Novotech (Australia) Pty Limited
Address [1] 282526 0
Level 3, 235 Pyrmont Street Sydney, NSW Australia - 2009
Country [1] 282526 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312258 0
The Alfred Hospital Ethics Committee HREC
Ethics committee address [1] 312258 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 312258 0
Australia
Date submitted for ethics approval [1] 312258 0
23/01/2023
Approval date [1] 312258 0
03/03/2023
Ethics approval number [1] 312258 0

Summary
Brief summary
This study aims to assess the safety, tolerability and pharmacokinetics of a new cancer treatment, SGR-1505 that may be used for non-Hodgkin's lymphoma patients. The study will consist of multiple parts that will assess administration of SGR-1505 alone and in combination with another treatment, posaconazole.

Who is it for?
You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that this study will not be enrolling patients with non-Hodgkin's lymphoma.

Study details
The first sub-study will enrol participants and test single doses of SGR-1505. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher single dose of SGR-1505.
The second sub-study will enrol participants and test multiple doses of SGR-1505 over a 10-day period. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher dose of SGR-1505 over a 10-day period.


It is hoped this research will determine the safest dose of SGR-1505 that can be administered with non-Hodgkin's lymphoma
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124014 0
Dr Dr. Jason Lickliter
Address 124014 0
Nucleus Network,
Level 5 Burnet Tower,
89 Commercial Road, Melbourne,
Victoria 3004
Country 124014 0
Australia
Phone 124014 0
+61 390768960
Fax 124014 0
Email 124014 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 124015 0
Dr Daniel Weiss
Address 124015 0
Schrödinger, Inc.,
1540 Broadway, 21st Floor, New York City, New York, 10036
Country 124015 0
United States of America
Phone 124015 0
+15032991150
Fax 124015 0
Email 124015 0
sdgr-trials-group@schrodinger.com
Contact person for scientific queries
Name 124016 0
Dr Daniel Weiss
Address 124016 0
Schrödinger, Inc.,
1540 Broadway, 21st Floor, New York City, New York, 10036
Country 124016 0
United States of America
Phone 124016 0
+15032991150
Fax 124016 0
Email 124016 0
sdgr-trials-group@schrodinger.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.