New drug combo takes on Hard-to-Treat cancers
NCT ID NCT04344795
First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 40 times
Summary
This early-phase trial tested an experimental oral drug called TPST-1495, given alone or with the immunotherapy Keytruda, in 89 people with advanced solid tumors (like colorectal, lung, and head/neck cancers) that had stopped responding to standard treatments. The main goals were to find the safest dose and to look for early signs that the drug might control tumor growth. Because this is a first-in-human study, the focus is on safety and dosing, not yet on proving the drug works.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Baystate Gynecologic Oncology
Springfield, Massachusetts, 01107, United States
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Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
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SCRI-OK Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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START Midwest
Grand Rapids, Michigan, 49546, United States
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Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
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South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229, United States
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Tennessee Oncology
Nashville, Tennessee, 37203, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
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University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
TPST-1495 (an experimental oral drug) and pembrolizumab (Keytruda, an immunotherapy)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 89 participants, so it is primarily testing safety and dosing. It is too soon to know if the drug will shrink tumors or improve survival, and side effects are expected.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.