- A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors. — Recruiting • Phase I • Oncology • NCT06898450.
- Drug Being Tested: NDI-219216, a novel investigational agent being evaluated for safety, tolerability, and efficacy in patients with advanced solid tumours through a phased clinical trial approach.
- Patient Eligibility Overview: The trial recruits patients with advanced solid tumours; specific eligibility criteria (performance status, organ function, prior treatment history) are typical for Phase I/II oncology studies but would be detailed in the full protocol.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * 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 * Resolution of all acute (or toxic) adverse effects of prior therapies, radiation therapy, or surgical procedures to Grade ≤ 1 (except fatigue, alopecia, and peripheral neuropathy).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.