RightFit
RecruitingPhase 1

A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NRM-823 is safe and can treat certain solid tumors. It is for people whose cancer has grown into nearby areas or spread to other parts of the body and has not responded to treatment.

This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have cancer confirmed by tissue or cell tests that has grown nearby or spread. Types include certain non-small cell lung cancers, triple-negative breast cancer, head and neck squamous cell cancer, certain cancers of the food pipe, stomach or where they meet, and cervical, uterine lining or ovarian cancer.
  • Be fully active or able to walk and do light work, with limits only on hard physical activity.
  • Have liver, kidney, lung and heart function that meets the study’s requirements.
  • Have blood cell levels that meet the study’s requirements.

Who can't join

  • Had chemotherapy, certain cancer medicines or radiation within 3 weeks before the first study dose, or within 5 drug half-lives, whichever is shorter. A half-life is the time it takes for half a drug to leave the body. Radiation only to bones is allowed.
  • Had moderate lung inflammation that needed steroids, or severe or life-threatening lung inflammation, from any past treatment.
  • Had an experimental treatment less than 4 weeks before the first study dose, or within 5 drug half-lives, whichever is shorter.
  • Still have side effects from past treatment that are more than mild when starting the study drug. Hair loss and mild or moderate nerve damage are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate liver, renal, pulmonary, and cardiac function. * Adequate hematologic function. Exclusion Criteria: * Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823 * History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy. * Has received an investigational therapy \<4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823. * With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.

Study sites (18)

CO

CT

DC

MA

MN

MO

NJ

OH

OK

PA

SC

TN

TX

VA