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Assessing a new treatment for advanced solid tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NDI-219216 in Patients With Advanced Solid Tumors With/Without Microsatellite Instability and/or Deficient Mismatch Repair

Phase1; Phase2 Interventional Nimbus Therapeutics · NCT06898450

This study is testing a new medication for people with advanced solid tumors to see if it is safe, how well it works, and what side effects it may cause.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment134 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorNimbus Therapeutics Industry-sponsored
Drugs / interventionsradiation
Locations22 sites (Los Angeles, California and 21 other locations)
Trial IDNCT06898450 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and efficacy of NDI-219216 in patients with advanced solid tumors, including those with microsatellite instability. Participants will take the medication daily and attend multiple clinic visits for monitoring and assessments. The study aims to determine the drug's side effects, its effects on the body, and its impact on tumor size. It is a first-in-human, open-label study that includes both dose escalation and optimization phases.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable or metastatic solid tumors who have not responded to standard therapies.

Not a fit: Patients with significant cardiovascular disease or known Werner syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.

How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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).

Exclusion Criteria:

* Clinically significant cardiovascular disease.
* Patients with known WRN syndrome.
* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.

Where this trial is running

Los Angeles, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid Tumors CancerMSI-H CancerAdvanced Solid TumorsMicrosatellite InstabilityDeficient Mismatch RepairWerner syndrome helicase
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.