Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
- Conditions
- Advanced Cancer
- Registration Number
- NCT05270213
- Lead Sponsor
- Riboscience, LLC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria:<br><br> 1. Be willing and able to provide written informed consent for the study. The subject<br> may also provide consent for Future biomedical research (FBR). However, the subject<br> may participate in the main study without participating in FBR.<br><br> 2. 18 years of age on day of signing informed consent.<br><br> 3. Male and female subjects with advanced unresectable, recurrent or metastatic tumors<br> who have received standard of care (SOC) therapy for their advanced/metastatic<br> tumors and have no other SOC therapy available. Additionally, subjects must have<br> received, have been intolerant to, have been ineligible for, or have declined all<br> treatment known to confer significant clinical benefit.<br><br> 4. Have histologically or cytologically confirmed cancer diagnosis based on pathology<br> report.<br><br> 5. Have a predicted life expectancy of greater or equal to 3 months.<br><br> 6. Have measurable disease based on RECIST 1.1.<br><br> 7. Have a performance status of 0, 1 or 2 using the ECOG Performance Scale within 14<br> days of first dose of study drug.<br><br> 8. Willing to submit a pre-treatment (archival or fresh-tissue if no archival is<br> available) and on-treatment tissue sample for intra-tumoral ENPP1 assessment.<br> Subjects in whom the treating physician deems such biopsy is clinically<br> contraindicated will be evaluated on a case-by-case basis for enrollment pending<br> Sponsor consultation.<br><br> 9. Have a negative urine or serum pregnancy test within 72 hours prior to receiving the<br> first dose of study drug female subjects of childbearing potential who are not<br> surgically sterilized or postmenopausal). If the urine test is positive, or cannot<br> be confirmed as negative, a serum pregnancy test will be required.<br><br> 10. Demonstrate adequate organ function: hematological, renal, hepatic, coagulation<br> parameters and obtained within 14 days prior to the first study treatment<br><br>Exclusion Criteria:<br><br> 1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule<br> therapy or radiation therapy within 2 weeks prior to trial Day 1; or if subject has<br> not recovered (i.e., Less than or equal to Grade 1 or returned to baseline level)<br> from adverse events due to a previously administered agent; the following exceptions<br> are allowed:<br><br> - Palliative radiotherapy for bone metastases or soft tissue lesions should be<br> completed > 7 days prior to baseline imaging<br><br> - Hormone-replacement therapy or oral contraceptives<br><br> - Subjects with Grade 2 neuropathy or Grade 2 alopecia<br><br> 2. Subjects with evidence of rapid progression on prior therapy resulting in rapid<br> clinical deterioration should be excluded from participation in the trial.<br><br> 3. Currently participating and receiving trial therapy or has participated in a trial<br> of an investigational agent and/or has used an investigational device within 28 days<br> prior to Day 1.<br><br> 4. Uncontrolled tumor-related pain<br><br> 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent<br> drainage procedures<br><br> 6. Malignancies other than indications open for enrollment within 3 years prior to Day<br> 1, with the exception of those with negligible risk of metastasis or death treated<br> with expected curative outcome, undergoing active surveillance or treatment-naïve<br> for indolent tumors<br><br> 7. Treatment with systemic immunomodulating agents (including but not limited to<br> Interferons (IFNs), Interleukin-2 (IL-2), anti-PD-1/PD-L1 inhibitors, ipilimumab)<br> within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first<br> dose.<br><br> 8. History of severe allergic, anaphylactic, or other hypersensitivity reactions to<br> chimeric or humanized antibodies or fusion proteins.<br><br> 9. Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in<br> Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor<br> formulation.<br><br> 10. Active autoimmune disease that has required systemic treatment in the past 2 years<br> (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive<br> drugs).<br><br> 11. History or any evidence of interstitial lung disease<br><br> 12. Treatment with systemic immunosuppressive medication within 2 weeks prior to<br> initiation of study treatment.<br><br> 13. Active HIV requiring therapy and Uncontrolled HIV*. HIV antibody testing recommended<br> per investigator's clinical suspicion.<br><br> 14. Severe infections within 4 weeks prior to enrollment, including, but not limited to,<br> hospitalization for complications of infection, bacteremia, or the presence of any<br> active infection requiring systemic therapy.<br><br> 15. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 1<br><br> 16. Received a live, attenuated vaccine within 28 days prior to enrollment/cohort<br> assignment or anticipation that such a live attenuated vaccine will be required<br> during the trial
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment emergent dose limiting toxicities (DLT);Peak plasma concentration (Cmax) of RBS2418;Area under the plasma concentration versus time curve (AUC);Optimal Biologically Active Dose;Half-life (t1/2);Number of participants with treatment emergent Adverse events
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR) by RECIST