Assessing a new treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of Chicago Medicine
  Chicago, Illinois, United States Recruiting
• University of Louisville James Graham Brown Cancer Center
  Louisville, Kentucky, United States Recruiting
• Levine Cancer Center
  Charlotte, North Carolina, United States Recruiting
• Atrium Health Wake Forest Baptist Center
  Winston-Salem, North Carolina, United States Recruiting
• Taylor Cancer Research Center
  Maumee, Ohio, United States Recruiting

Study contacts

• Study coordinator: Sean Rossi
• Email: sean.rossi@nimbustx.com
• Phone: 857-600-8779

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PQ203 for advanced solid tumors including triple negative breast cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.