A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNimbus Wadjet, Inc.
About this trial
The goal of this clinical trial is to learn if NDI-219216 is safe for patients, and if NDI-219216 might be a possible treatment for advanced solid tumors in the later phases of the study.
The main questions it aims to answer are:
Is NDI-219216 safe and what kinds of side effects might it cause? What kind of effects does NDI-219216 have on the body? Does NDI-219216 have any impact on tumor size?
Participants will:
Take NDI-219216 every day by mouth. Visit the clinic 6 times during Cycle 1, 2 times during Cycle 2, once a month thereafter for checkups and tests while on the study, then one time for an end of treatment visit. After the End of Study, a follow up will occur but can be done on the phone.
Keep a diary of their tablet consumption and symptoms experienced.
Eligibility criteria
Qualifiers
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Have unresectable and/or metastatic solid tumors (with or without MSI-H/dMMR) refractory to or intolerant to previous SoC therapy or for which no SoC therapy exists
Presence of measurable disease according to RECIST version 1.1 except for Part A (Dose Escalation)
Adequate bone marrow / hematologic, end-organ, and cardiovascular function
Disqualifiers
Clinically significant cardiovascular disease.
Patients with known WRN syndrome.
Pregnancy, breastfeeding, or intention of becoming pregnant during the study.
Trial design
Treatments tested in this trial
- NDI-219216
Treatment groups
134 Participants
are divided into 3 treatment groupsSponsors and collaborators
Nimbus Wadjet, Inc.
Lead sponsor
Worldwide Clinical Trials
Collaborator
Source ClinicalTrials.gov