Expanded Access in Pancreatic CancerNCT05683470
Expanded Access RBS2418 Treatment
A study testing RBS2418 in people with Expanded Access in Pancreatic Cancer, run by Riboscience, LLC..
Trial summary
This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Expanded Access in Pancreatic Cancer
- What is being tested?
- RBS2418
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol.
Who cannot join
- Not applicable
About this study
Official title: Expanded Access to RBS2418 for an Individual Patient With Pancreatic Cancer
This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.
Read the detailed description
Given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with RBS2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. Furthermore, patient's tumor has been shown to express ENPP1, the protein targeted by RBS2418
- Conditions
- Expanded Access in Pancreatic Cancer
- Being tested
- RBS2418
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBS2418Drug
RBS2418 will be administered orally at 200 mg two times per day (BID).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Expanded Access in Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Riboscience, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Bertrand Tuan
- Responsible party
- Sponsor
- Investigators
- Bertrand Tuan, MD, Principal investigator, Pacific Hematology and Oncology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683470
- Sponsor's protocol ID
- RBS2418-EA-002
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to RBS2418 for an Individual Patient With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05683470
- Acronym / sponsor ID
- RBS2418-EA-002
- Conditions
- Expanded Access in Pancreatic Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Riboscience, LLC.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Bertrand Tuan
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.
Detailed description
Given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with RBS2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. Furthermore, patient's tumor has been shown to express ENPP1, the protein targeted by RBS2418
Study design
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patient is willing and able to provide informed consent. Only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the PI. No other patient is authorized to participate in or to receive treatment under this treatment protocol.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBS2418RBS2418 will be administered orally at 200 mg two times per day (BID). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Tuan, MD principal investigator
Pacific Hematology and Oncology Associates
Questions about this trial
What is this clinical trial studying?
A study testing RBS2418 in people with Expanded Access in Pancreatic Cancer, run by Riboscience, LLC..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.