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Protocol Details

A Phase 1/2, Open Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects with Advanced or Metastatic Solid Tumors

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Next Cure Inc.;
T-cell Activation;
Intravenous Infusion;
First in Human (FIH);
LAIR-2 IgG1 Fusion protein

Recruitment Keyword(s)



Advanced Non-Small Cell Lung Cancer;
Metastatic Head and Neck Squamous Cell Carcinoma;
Ovarian Cancer;
Gastric Cancer;
Colorectal Cancer

Investigational Drug(s)


Investigational Device(s)



Drug: NC-410

Supporting Site

National Cancer Institute


Sometimes the body's own immune system may slow down or control cancer growth. Other times, though, this natural immune system response stops, and the cancer is not killed by the immune system. Researchers think a drug called NC410 might be able to help the immune system and people with advanced cancer.


To test any good and bad effects of NC410.


Adults age 18 and older who have advanced cancer or metastatic cancer that has not gotten better after treatment or treatment could not be tolerated.


Participants will be screened with a medical history. It will include their cancer and medicine history. They will give data on their age, sex, race, and ethnicity. They will have a physical exam. Their height and weight will be measured. Their vital signs, such as blood pressure, temperature, and pulse rate, will be checked. They will be assessed for how their condition impacts their life and activities. They will give blood and urine samples. Their tumors will be measured using imaging scans, such as CT (computed tomography) scans or MRI (magnetic resonance imaging) scans. They will have an electrocardiogram to check heart function.

Some screening tests will be repeated during the study.

Participants will get NC410 every 14 days as an intravenous (IV) infusion. They will get the study drug for up to 12 months, until their cancer gets worse, or until they choose to leave the study.

Participants will have an end-of-treatment visit and 2 safety follow-up visits.

Participation will last for up to 16 months.

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Dose escalation (Phase 1a)

- Patients with advanced solid tumors who have progressed on standard treatment or have been unable to tolerate standard therapy or who refused standard therapy or for whom no

standard therapy exists

- Age > 18 years or older

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Ravi A. Madan, M.D.
National Cancer Institute (NCI)

(301) 480-7168

Erica Y. Redmond
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N254
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3783

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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