South African National Clinical Trials Registry
South African Medical Research Council, Cochrane South Africa
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: sactradmin@mrc.ac.za Website: sanctr.samrc.ac.za
Trial no.: DOH-27-112024-4693 Date of Approval: 08/11/2024
Trial Status: Approved
TRIAL DESCRIPTION
Public title RHN001-DX/TX in men with PSMA-positive prostate cancer
Official scientific title A Phase I/II study of RHN001-DX/TX in men with PSMA-positive prostate cancer post adjuvant androgen deprivation therapy and/or taxane-based chemotherapy
Brief summary describing the background and objectives of the trial As of 2020 the global incidence of prostate cancer was over 1.4 million, with over 375,000 deaths. When compared to 2012 figures, an upward trend was seen. Various peptide receptor radioligand therapies have been explored and some have been FDA approved.Despite this, the access to [177Lu] Lu-PSMA-617 and PET/CT imaging facilities remains a challenge in low-income countries. These are costly and not readily available. In the low-income countries without access to PET/CT imaging, [99mTc]Tc is readily available making it a feasible option for imaging with the widely available gamma cameras. Therefore, development of a cheaper and therapeutic agent whose radionuclide has similar chemistry to that of [99mTc]Tc may address this need. [188Re]Re is the ideal candidate since it has similar chemical properties with that of [99mTc]Tc it can label similar compounds with ease. One of the compounds that has been designed to suit this role is the PSMA targeting RHN001 which can be labelled with both [99mTc]Tc and [188Re]Re for imaging and therapy respectively. Primary objective: • To identify the recommended Phase 2 dose (RP2D), and schedule of administration for RHN001-TX in men with progressive PSMA-positive prostate cancer who have had neoadjuvant androgen deprivation therapy and/or taxane-based chemotherapy. Secondary objectives: • Assess the overall safety including the dosimetry of RHN001-TX in men with PSMA-positive prostate cancer. • Assess the safety including the dosimetry of RHN001-DX in men with prostate cancer. • Assess health-related quality of life: Functional Assessment of Cancer Therapy- Prostate (FACT-P), Brief Pain Inventory-Short Form (BPI-SF), EQ-5D-5L and XeQOLS xerostomia questionnaire.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 28/02/2025
Actual trial start date 27/02/2025
Anticipated date of last follow up 28/02/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 27
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://clinicaltrials.gov
Secondary Ids Issuing authority/Trial register
RHN001-100 Sponsor
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RHN001 Patients will receive RHN001-DX for diagnostic purposes and RHN001-TX for therapeutic purposes. RHN001-DX with whole-body imaging will be done prior to the study and before subsequent cycles of RHN001-TX. The RHN001-TX will be given for a maximum of 4 cycles for patient receiving eMTD (50%, 65% and 75%); whereas 3-cycles in patients receiving 100% of eMTD. Cohort A: Dosimetry for RHN001-DX RHN001-DX containing 10µg of the peptide at a specific activity (MBq) will be injected intravenously. Activity will be adjusted for patient weight. Cohort B: Dosimetry for RHN001-TX RHN001-TX containing 10µg of the peptide at a specific activity (MBq) will be injected intravenously. Activity will be adjusted for patient weight. Cohort C: Escalation study with RHN001-TX Administered activity will be based in the estimated maximum tolerable dose(eMTD). These patients will be divided into 4-groups with administration of 50%, 65%, 75% and 100% eMTD with activities, number of cycles and cycle interval. Cohort A and B once off administration Cohort C up to a maximum of 3-4 cycles every 4-6 weeks depending on the group. Study eligible patients will be assigned to one of three cohorts. • Cohort A- RHN001-DX dosimetry cohort: Dosimetry of diagnostic use of RHN001-DX. The required number of patients will be five(n=5). • Cohort B- RHN001-TX dosimetry cohort: Treatment of men with metastatic PSMA-positive prostate cancer on RHN001-DX whole body imaging with or without therapies. The required number of patients will be five(n=5). • Cohort C: Escalation study with RHN001-TX Treatment of men with mCRPC PSMA-positive on RHN001-DX whole body imaging post adjuvant androgen deprivation therapy and/or taxane based chemotherapy. These patients will be divided into 4-groups with administration of different % of the eMTD The number of patients per group in this cohort of patients will be three(n=3) 22
Control Group No control group Not applicable Not applicable Not applicable. 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: 1) Patient must have the ability to understand and sign an approved ICF. 2) Patient must have the ability to understand and comply with all protocol requirements. 3) Patients must be ≥18 years of age. 4) Patients must have an ECOG performance status of 0 to 2. 5) Patient must have had histological, pathological and/or cytological confirmation of prostate cancer. 6) Patients with measurable disease on CT as per PCWG3 recommendations. 7) Patient must have a positive RHN001-DX whole-body imaging performed within 14-days of study entry 8) Patients must have recovered or stabilized to ≤Grade 2 or baseline from all clinically significant toxicities related to prior prostate cancer therapy. 9) Determination of disease progression on treatment prior to enrolment. 10) Patients must have adequate organ function 11) Known HIV-positive patients who are healthy and have a low risk of AIDS-related outcomes are eligible. 12) For patients who have partners of childbearing potential, Patients must use a method of birth control 13) RHN001-DX dosimetry cohort: The patients must be newly diagnosed and have low-volume disease. 14) RHN001-TX dosimetry cohort: The patients must be able to tolerate serial imaging preferably ECOG 0. 1) Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, radium-223 or hemi-body irradiation (Lu-177 or Ac-225 PSMA). 2) Any investigational agents within 28 days of study enrolment. 3) Known hypersensitivity to the components of the study for imaging and therapy and the respective analogues. 4) Other concurrent cytotoxic chemotherapy targeted therapy, biologic agents, immunotherapy, radioligand therapy, or investigational therapy. 5) Transfusion for the purposes of eligibility into the study. 6) Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and are not neurologically impaired. 7) Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 8) Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. 9) Patients with a prior history of malignancy which may interfere with disease assessment who have been disease-free for more than 3 years are eligible. Adult: 19 Year(s)-105 Year(s) 18 Year(s) 100 Year(s) Both
APPROVALS
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/07/2024 SAHPRA
Ethics Committee Address
Street address City Postal code Country
Building A, Loftus Park 2nd Floor, Kirkness Street Arcadia Pretoria 0083 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/09/2024 University of Pretoria Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Pretoria Faculty of Health Sciences Tswelopele Building, Level 4, Rooms 4-59 and 4-60 (opposite the BMS Building), 9 Bophelo Road, Gezina, Pretoria Pretoria 0001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To identify the recommended Phase 2 dose (RP2D), and schedule of administration for RHN001-TX in men with progressive PSMA-positive prostate cancer who have had neoadjuvant androgen deprivation therapy and/or taxane-based chemotherapy. End of Study
Secondary Outcome Assess the overall safety including the dosimetry of RHN001-TX in men with PSMA-positive prostate cancer. End of Study
Secondary Outcome Assess the safety including the dosimetry of RHN001-DX in men with prostate cancer. End of Study
Secondary Outcome Assess health-related quality of life: Functional Assessment of Cancer Therapy- Prostate (FACT-P), Brief Pain Inventory-Short Form (BPI-SF), EQ-5D-5L and XeQOLS xerostomia questionnaire. End of Study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Prof Mike Sathekge Department of Nuclear Medicine Steve Biko Academic Hospital University of Pretoria Corner of Steve Biko and Malan Stre Pretoria 0001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Nuclear Medicine Research Infrastructure NuMeRi Steve Biko Hospital, Corner of Steve Biko Road and Malan Street, Capital Park Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nuclear Medicine Research Infrastructure Room 51312 Level 5 Bridge A, Cnr Steve Biko and Malan Street, Capital Park Pretoria 0001 South Africa Non-profit Research Company
COLLABORATORS
Name Street address City Postal code Country
Rhine Pharma GmbH Schweriner Strasse 50a Dresden 01067 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mike Sathekge mike.sathekge@up.ac.za 0027834617653 Steve Biko Academic Hospital
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Sponsor
Role Name Email Phone Street address
Scientific Enquiries Honest Ndlovu honest.ndlovu@sanumeri.co.za 0027816032807 Steve Biko Academic Hospital
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Sponsor
Role Name Email Phone Street address
Public Enquiries Tertia De Bruin tertia.debruin@abx-cro.com 0027832279896 101, Big Bay Office Park, Beach Estate Boulevard, Big Bay
City Postal code Country Position/Affiliation
Cape Town 7441 South Africa CRO
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes External qualified researchers may request IPD for this study after the study is completed or during the study for inspection. As per the informed consent "Any information obtained in connection with this clinical trial that can identify you will remain confidential. You will be identified by a trial code/participant number. Your health records and any information obtained during the research project are subject to inspection (for verifying the procedures and the data) by the relevant authorities and authorised representatives of the Sponsor. It is anticipated that the results of this clinical trial will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. Informed Consent Form,Study Protocol As per informed consent "The trial (study) doctor will keep the list matching your participant trial code/participant number with your medical and identifying information for at least 15 years after the end of the trial or for at least 2 years after the investigational product is approved for sale by relevant regulatory agencies (whichever comes later). A secured external system with username and password.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 11/02/2025 Updated information 01 Jan 2025 28 Feb 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 05/03/2025 Updated information 27 Feb 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 11/02/2025 Updated information 31 Dec 2026 28 Feb 2027
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 11/02/2025 Updated information 22 27
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/03/2025 Updated information. Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 04/11/2024 Patients will not be randomized. The patients will receive similar IMP at different doses in different stages of the clinical trial. (Dose escalation) Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Single Group
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 10/02/2025 Updated Information ABXCRO Advanced Pharmacuetical Services Forschungsgesellschaft mbH, Schossergasse 19, Dresden, 01067, Germany Rhine Pharma GmbH, Schweriner Strasse 50a , Dresden, 01067, Germany
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 06/11/2024 Updated upon request from SAMRC IPD sharing statement will be provided within 12 months of study completion date. The results of this trial will be publicly disclose or submit for publication as an article, manuscript, abstract, poster, presentation, or other material, in written or electronic form. External qualified researchers may request IPD for this study after the study is completed or during the study for inspection. As per the informed consent "Any information obtained in connection with this clinical trial that can identify you will remain confidential. You will be identified by a trial code/participant number. Your health records and any information obtained during the research project are subject to inspection (for verifying the procedures and the data) by the relevant authorities and authorised representatives of the Sponsor, the institution relevant to this Participant Information Sheet, Steve Biko Academic Hospital (SBAH), or as required by law (including SAHPRA, National Health Research Ethics Council (NHREC), relevant Independent Ethics Committee (IEC) and/or other regulatory authorities. It is anticipated that the results of this clinical trial will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 06/11/2024 Updated upon request from SAMRC External qualified researchers may request IPD for this study after the study is completed or during the study for inspection. As per the informed consent "Any information obtained in connection with this clinical trial that can identify you will remain confidential. You will be identified by a trial code/participant number. Your health records and any information obtained during the research project are subject to inspection (for verifying the procedures and the data) by the relevant authorities and authorised representatives of the Sponsor, the institution relevant to this Participant Information Sheet, Steve Biko Academic Hospital (SBAH), or as required by law (including SAHPRA, National Health Research Ethics Council (NHREC), relevant Independent Ethics Committee (IEC) and/or other regulatory authorities. It is anticipated that the results of this clinical trial will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission. External qualified researchers may request IPD for this study after the study is completed or during the study for inspection. As per the informed consent "Any information obtained in connection with this clinical trial that can identify you will remain confidential. You will be identified by a trial code/participant number. Your health records and any information obtained during the research project are subject to inspection (for verifying the procedures and the data) by the relevant authorities and authorised representatives of the Sponsor. It is anticipated that the results of this clinical trial will be published and/or presented in a variety of forums. In any publication and/or presentation, information will be provided in such a way that you cannot be identified, except with your permission.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 06/11/2024 Timeframe updated as per ICF Within 12 months of study completion date if required by law. As per informed consent "The trial (study) doctor will keep the list matching your participant trial code/participant number with your medical and identifying information for at least 15 years after the end of the trial or for at least 2 years after the investigational product is approved for sale by relevant regulatory agencies (whichever comes later).
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 06/11/2024 Updated information To be shared if required by law. A secured external system with username and password.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 06/11/2024 Updated information www.clinicaltrials.gov