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New treatment option for Advanced Cancer
Official title Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05270213
What this study is testing
What is RBS2418?
RBS2418 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with other cancer treatments including monotherapy and in combination with other cancer treatments including immunotherapy or chemotherapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be willing and able to provide written informed consent for the study. The subject may also provide consent for Future biomedical research (FBR)...
- 18 years of age on day of signing informed consent.
- Male and female people with advanced unresectable, recurrent or metastatic tumors who have received standard of care (SOC) therapy for their...
- Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
- Have a predicted life expectancy of greater or equal to 3 months.
You likely can't join if
- Use of any systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy or immunotherapy) within 2 weeks prior to first dose...
- Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \> 7 days prior to baseline imaging
- Hormone-replacement therapy or oral contraceptives
- people with Grade 2 neuropathy or Grade 2 alopecia
- people with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the...
- Currently participating and receiving trial therapy or has participated in a trial of an investigational agent and/or has used an investigational...
See the full eligibility criteria
Who can join
- Be willing and able to provide written informed consent for the study. The subject may also provide consent for Future biomedical research (FBR). However, the subject may participate in the main study without...
- 18 years of age on day of signing informed consent.
- Male and female people with advanced unresectable, recurrent or metastatic tumors who have received standard of care (SOC) therapy for their advanced/metastatic tumors and have no other SOC therapy available...
- Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
- Have a predicted life expectancy of greater or equal to 3 months.
- Have measurable disease based on RECIST 1.1.
- Have a performance status of 0, 1 or 2 using the ECOG Performance Scale within 14 days of first dose of study drug.
- Willing to submit a pre-treatment (archival or fresh-tissue if no archival tissue is available) and on-treatment tissue sample. people in whom the treating physician deems such biopsy is clinically contraindicated will...
- Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug (female people of childbearing potential who are not surgically sterilized or postmenopausal). If the urine...
- Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters and obtained within 14 days prior to the first study treatment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two highly effective contraceptive methods that result in a combined failure rate of \< 1% per year...
- For male people: Agree that during the period specified above, men will not father a child. Male people must remain abstinent (refrain from heterosexual intercourse with women of childbearing potential), must be...
What rules you out
- Use of any systemic anti-cancer therapy (including radiotherapy, chemotherapy, targeted therapy or immunotherapy) within 2 weeks prior to first dose of RBS2418 unless such therapy is being administered in combination...
- Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \> 7 days prior to baseline imaging
- Hormone-replacement therapy or oral contraceptives
- people with Grade 2 neuropathy or Grade 2 alopecia
- people with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
- Currently participating and receiving trial therapy or has participated in a trial of an investigational agent and/or has used an investigational device within 28 days prior to Day 1.
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Malignancies other than indications open for enrollment within 3 years prior to Day 1, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active...
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity allergy or contraindication to any investigational product components administered as part of the combination therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- History or any evidence of interstitial lung disease
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment.
- Active HIV requiring therapy and Uncontrolled HIV\ . HIV antibody testing recommended per investigator's clinical suspicion.
- Active hepatitis B virus (HBV; hepatitis B surface antigen reactive) or active hepatitis C virus (HCV; qualitative RNA detected)\ ; such as requiring active therapy (e.g. people with a history of HCV are eligible as...
- Severe infections within 4 weeks prior to enrollment, including, but not limited to, hospitalization for complications of infection, bacteremia, or the presence of any active infection requiring systemic therapy.
- Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 1
- History or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the treating investigator might confound the results of the trial or interfere with the subject's participation for...
- people with:
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval of \> 480 milliseconds (ms) (CTCAE Grade 1) using Fridericia's QT correction formula
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- The use of concomitant medications that are known to prolong the QT/QTc interval unless there is evidence of the lack of QT/QTc interval prolongation at baseline.
- people with gastrointestinal disorders that may affect the absorption of the drug
- Prior allogeneic stem cell or solid organ transplant.
- Received a live, attenuated vaccine within 28 days prior to enrollment/cohort assignment or anticipation that such a live attenuated vaccine will be required during the trial
- Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Prisoner or subject who is compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infectious disease) illness.
- Pregnant or lactating or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit through 120 days after the last dose of pembrolizumab and/or RBS2418.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Palo Alto, California, United States
- Santa Monica, California, United States
- Newark, Delaware, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- New York, New York, United States
- Huntersville, North Carolina, United States
- Nashville, Tennessee, United States
- Webster, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Tucson, Arizona, United States; Palo Alto, California, United States; Santa Monica, California, United States; Newark, Delaware, United States; Louisville, Kentucky, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.