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

RECRUITINGPhase 1Sponsored by Normunity AccelCo, Inc.

Actively Recruiting

PhasePhase 1

SponsorNormunity AccelCo, Inc.

Started2025-10-30

Est. completion2027-05-30

Eligibility

Age18 Years+

Healthy vol.Accepted

Locations9 sites

View on ClinicalTrials.gov →

NCT07182149

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted

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.

Conditions12

Breast CancerCancerCervical CancerESCCEndometrial CancerEsophageal AdenocarcinomaGEJ AdenocarcinomaGastric AdenocarcinomaHNSCCNSCLC