Recruiting

Testing a new cancer treatment alone and with immunotherapy

Plain-English translation of NCT05669430 on ClinicalTrials.gov ↗ · Source last updated February 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This is a study of a new cancer medication called being tested in people with advanced cancers that have not responded to standard treatments. Researchers want to find the safest and most effective dose of this medication when given alone, and also test how well it works when combined with an existing immunotherapy drug called pembrolizumab. The trial has four parts, starting with finding the right dose and moving on to testing how well the treatment actually works against different types of cancer.

Many people with advanced cancers run out of effective standard treatment options, and their cancer becomes resistant to available therapies. This medication is being studied to offer a new treatment choice for these patients, and researchers want to learn whether combining it with existing immunotherapy might work even better.

Do you qualify?

You likely qualify if…

you are 18 years of age or older
you have been diagnosed with an advanced solid tumor (cancer) that is no longer responding to standard treatments or you cannot tolerate standard therapies
you have measurable disease that can be tracked on scans or imaging
you are in good enough health to participate (having an Eastern Cooperative Oncology Group performance status of 0 or 1)
you have a life expectancy of at least 12 weeks (or 24 weeks for later trial phases)
you are willing to have tumor biopsies taken before and during treatment

You likely don't qualify if…

you have active heart disease or unstable heart rhythm problems
you have an active infection (bacterial, viral, or fungal) that requires treatment with medications
you have an active autoimmune disease or are taking chronic steroids or immune-suppressing medications
you are pregnant or nursing
you have had a severe allergic reaction (Grade 3 or higher) to immunotherapy drugs in the past

What participation looks like

Participation involves receiving the medication either alone or in combination with pembrolizumab during study visits at a medical center. Early in the trial, researchers will carefully increase the dose step-by-step to find the safest level; later participants will receive the established dose and be monitored for how well the treatment works. You will need tumor biopsies (small tissue samples) taken before and during treatment, along with blood tests and imaging scans to track your response.

AI-generated summary from trial data · Jun 18, 2026 · Not medical advice

Trial locations(13 sites)

United States

The Angeles Clinic and Research Institute, Los Angeles, California

HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE, Denver, Colorado

Yale University, New Haven, Connecticut

Florida Cancer Specialists & Research Institute, LLC, Fort Myers, Florida

Community Health Network, Inc., Indianapolis, Indiana