NC410 + Pembrolizumab for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NextCure, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

Eligibility Criteria

Adults with advanced unresectable/metastatic solid tumors, including specific cancers like colorectal, stomach, esophageal, and ovarian. Participants must have progressed after standard therapy or be ICI refractory. They should agree to contraception use and not expect a child soon. Adequate organ function and an ECOG status of 0-1 are required.

Inclusion Criteria

My cancer is not highly mutated and has worsened after treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer is advanced, cannot be surgically removed, and may have spread.

My cancer has worsened despite treatment with specific immune therapy.

My cancer is not highly mutated and I haven't been treated with immune checkpoint inhibitors after it worsened following standard treatment.

I am at least 18 years old.

I can provide a recent (within 5 years) or new biopsy of my tumor that hasn't been treated with radiation.

Exclusion Criteria

I have not received a live vaccine in the last 30 days.

I have another cancer that is getting worse or was treated in the last 3 years.

I have or had lung inflammation that needed steroids.

I am currently being treated for an infection.

I have received a transplant from another person.

I have an immune system disorder or have been on steroids or other immune-weakening drugs recently.

I am severely allergic to Pembrolizumab, NC410, or their ingredients.

I have a known history of HIV.

I have been treated for an autoimmune disease in the last 2 years.

I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.

I stopped a cancer treatment due to severe side effects.

I received a COVID-19 vaccine less than 14 days before starting the study treatment.

I have active brain metastases or cancer in the lining of my brain.

Participant Groups

The trial is testing the combination of NC410 with Pembrolizumab for safety, tolerability, and effectiveness in treating various advanced solid tumors that are either resistant to immune checkpoint inhibitors (ICIs) or haven't been treated with ICIs if they're microsatellite stable/low.

1Treatment groups

Experimental Treatment

Group I: NC410 and pembrolizumabExperimental Treatment2 Interventions

All participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.