Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiboscience, LLC.
About this trial
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.
Eligibility criteria
Qualifiers
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 participating in FBR.
18 years of age on day of signing informed consent.
Male and female subjects 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. 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.
Have histologically or cytologically confirmed cancer diagnosis based on pathology report.
Disqualifiers
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
Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial.
Trial design
Treatments tested in this trial
- RBS2418
- Pembrolizumab
- Other approved anti-cancer therapy
Treatment groups
164 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov