OncoMatch/Clinical Trials/NCT05270213
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
Is NCT05270213 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including RBS2418 and Pembrolizumab for advanced cancer.
Treatment: RBS2418 · Pembrolizumab · Other approved anti-cancer therapy — 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. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or other approved anticancer therapies or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors. The phase 1a (dose escalation phase) has been completed. The Phase 1b expansion phase of the study has been increased in size and scope.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Allowed: ENPP1 baseline expression level available
ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study
Allowed: MB21D1 baseline expression level available
ENPP1 and/or cGAS baseline expression level in the subject's tumor must be available and may guide enrolment eligibility for the study
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care therapy — advanced/metastatic
have received standard of care (SOC) therapy for their advanced/metastatic tumors and have no other SOC therapy available. Additionally, subjects must have received, have been intolerant to, have been ineligible for, or have declined all SOC therapies known to confer significant clinical benefit.
Cannot have received: systemic anti-cancer therapy
Exception: unless such therapy is being administered in combination with RBS2418 per protocol and has been approved by the Sponsor; or if subject has not recovered (i.e., Less than or equal to Grade 1 or returned to baseline level) from adverse events due to a previously administered agent; exceptions: palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging; hormone-replacement therapy or oral contraceptives; subjects with Grade 2 neuropathy or Grade 2 alopecia
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 with RBS2418 per protocol and has been approved by the Sponsor; or if subject has not recovered (i.e., Less than or equal to Grade 1 or returned to baseline level) from adverse events due to a previously administered agent; the following exceptions are allowed: Palliative radiotherapy for bone metastases or soft tissue lesions should be completed > 7 days prior to baseline imaging; Hormone-replacement therapy or oral contraceptives; Subjects with Grade 2 neuropathy or Grade 2 alopecia
Cannot have received: investigational agent/device
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
Lab requirements
Blood counts
adequate hematological function required
Kidney function
adequate renal function required
Liver function
adequate hepatic function required
Demonstrate adequate organ function: hematological, renal, hepatic, coagulation parameters and obtained within 14 days prior to the first study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Honor Health Research Institute · Scottsdale, Arizona
- University of Arizona · Tucson, Arizona
- Stanford Cancer Institute · Palo Alto, California
- UCLA Hematology/Oncology - Santa Monica · Santa Monica, California
- Christiana Care Health Services · Newark, Delaware
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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