A study to evaluate the safety, tolerability, processing by the body, and response of the body to the drug RO7497987 in single and multiple ascending doses in healthy volunteers
| ISRCTN | ISRCTN92655801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92655801 |
| Secondary identifying numbers | GO43310 |
- Submission date
- 24/11/2021
- Registration date
- 29/11/2021
- Last edited
- 07/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
The aim of this study is to test the drug RO7497987 at different doses to find out if it is safe, to find out the effects of RO7497987 on the body, and to understand how the human body processes it. In this study, participants will receive either one or two dose(s) of RO7497987. RO7497987 is an experimental drug, which means health authorities have not approved RO7497987 for the treatment of any disease, and it has not been tested in people before this study.
Who can participate?
Healthy people aged between 18 to 65 years old.
What does the study involve?
Participants will be screened to see if they may participate in the study. During screening, participants undergo a physical examination and electrocardiogram (ECG) and blood and urine samples will be taken. In addition, their height, weight, and vital signs will be measured.
Participants will be placed in one of the following treatment groups. Group 1 will receive one dose of RO7497987 given as an infusion (into the vein). Group 2 will receive multiple doses of RO7497987, given as an infusion.
Treatment will be given in a clinic. Participants will be required to check into the treatment center 1 day before they receive the study treatment, and the duration of time participants will stay in the treatment center is based on the treatment assigned.
After the treatment period ends, participants will return to the clinic for follow-up visits. During these visits, participants will be asked about their well-being, their vital signs will be taken and additional blood samples will be collected.
What are the possible benefits and risks of participating?
Participants will not receive any benefit from participating in this study, but the information that is learned may help people with certain cancers in the future.
The potential side effects related to the study drug, based on laboratory studies or knowledge of similar drugs, are listed below:
1. Infusion-related or allergic reaction with symptoms such as fever, chills, etc
2. Minimal to mild increase in liver enzymes
3. Increase in the size of participant’s lymph nodes, spleen, or other organs
4. Interactions with vaccine/immunisation
5. There may be a risk in exposing an unborn child to the study drug, and all the risks are not known at this time.
Where is the study run from?
F. Hoffmann-La Roche (USA)
When is the study starting and how long is it expected to run for?
June 2021 to January 2023
Who is funding the study?
F. Hoffmann-La Roche (USA)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Public
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Phase IA open-label single-centre dose-escalation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | A Phase IA, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497987 in single and multiple ascending doses in healthy volunteers |
| Study hypothesis | RO7497987 will be safe and well-tolerated in healthy volunteers. |
| Ethics approval(s) | Approved 14/10/2021, WCG IRB (1019 39th Avenue SE, Suite 120, Puyallup, WA, 98374, USA; +1 (0)855 818 2289; researchquestions@wcgirb.com [given to subjects], clientservices@wcgirb.com [for CROs to contact the IRB]), ref: 20215288 |
| Condition | Safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497987 |
| Intervention | Single Ascending Dose (SAD): RO7497987 monotherapy single dose given intravenously (IV) at Cycle 1 Day 1. Cohorts of at least 6 participants each will be treated at escalating doses of RO7497987 Multiple Ascending Dose (MAD): RO7497987 monotherapy given intravenously (IV) at Cycle 1 Day 1 and Cycle 2 Day 1, 21 days apart. Cohorts of at least 6 participants each will be treated with RO7497987 at dose levels determined based on the safety data, tolerability, pharmacokinetics, and pharmacodynamics tested in the SAD cohorts |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | RO7497987 |
| Primary outcome measure | 1. Percentage of participants with adverse events and severity per National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0) from screening up to approximately 13 months 2. Targeted vital signs measured using clinical examinations at every visit from study initiation up to approximately 3 months after the last dose 3. Targeted clinical laboratory test results measured using blood and urine samples at selected timepoints from study initiation up to approximately 3 months after the last dose |
| Secondary outcome measures | 1. Myeloid cells in the peripheral blood following administration of RO7497987 measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 2. Serum concentration of RO7497987 measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 3. Pharmacokinetic parameters (i.e., AUC, Tmax, Cmax, CL, Vss/F, and t1/2) measured using blood samples at multiple timepoints from study initiation up to approximately 3 months after the last dose 4. Prevalence and incidence of anti-drug antibodies measured using blood samples at baseline and after initiation of study treatment, from study initiation up to approximately 13 months |
| Overall study start date | 24/06/2021 |
| Overall study end date | 19/01/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Age ≥18 years and ≤65 years at the time of signing Informed Consent Form (ICF) 2. A minimum weight of 40 kg at screening 3. Body mass index of 18-32 kg/m² at screening 4. Adequate hematologic and end-organ function |
| Participant exclusion criteria | 1. History or active diseases of bone marrow disorders 2. History of malignancy within 5 years prior to screening 3. Vaccine immunization within 2 weeks prior to initiation of study drug 4. Known infection/COVID-19 positive or persistent symptoms of SARS-CoV-2 5. HIV positive 6. Active Hepatitis B or Hepatitis C infections 7. Current tobacco use 8. History or currently active of autoimmune disease 9. Significant cardiovascular disease 10. Known clinically significant liver and renal diseases |
| Recruitment start date | 30/11/2021 |
| Recruitment end date | 28/08/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
66219
United States of America
Sponsor information
Industry
Building 1, Grenzacherstrasse 124
Basel
CH-4070
Switzerland
| Phone | +1 888-662-6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | https://www.roche.com/about_roche/roche_worldwide.htm |
"ROR" |
https://ror.org/011qkaj49 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 19/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement |
Editorial Notes
07/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 28/08/2022.
2. The overall end date was changed from 28/04/2023 to 19/01/2023.
3. The intention to publish date was changed from 28/04/2024 to 19/01/2024.
4. The sponsor details were updated.
5. The contact details were updated.
6. The plain English summary was updated to reflect these changes.
25/11/2021: Trial's existence confirmed by WCG IRB.
