NCT07182149 A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
| NCT ID | NCT07182149 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Normunity AccelCo, Inc. |
| Condition | HNSCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2025-10-30 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Viviana Bozon, MD
STUDY DIRECTOR
Normunity AccelCo, Inc.
Frequently Asked Questions
Who can join the NCT07182149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HNSCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07182149 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07182149 currently recruiting?
Yes, NCT07182149 is actively recruiting participants. Contact the research team at judy.schnyder@normunity.com for enrollment information.
Where is the NCT07182149 trial being conducted?
This trial is being conducted at Denver, United States, New Haven, United States, Minneapolis, United States, Maumee, United States and 5 additional locations.
Who is sponsoring the NCT07182149 clinical trial?
NCT07182149 is sponsored by Normunity AccelCo, Inc.. The principal investigator is Viviana Bozon, MD at Normunity AccelCo, Inc.. The trial plans to enroll 150 participants.