🏛️ Verified NIH Record • Updated 2026-02-19

A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies (NCT05753722)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Incendia Therapeutics

🩺 Plain-English Summary (8th-Grade Level)

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (22 items).

Location: Honor Health Research Institute — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Subject has received prior treatment with systemic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies (e.g., checkpoint inhibitors) within 28 days or five half-lives of the drug, whichever is shorter.
  • Subject has ongoing toxicity from prior therapy \>Grade 1 according to the CTCAE, with the following exceptions. Such exceptions must be assessed by the Investigator (and approved by the Sponsor) as not placing the subject at undue safety risk from participating in this study.
  • Alopecia, and vitiligo
  • Grade ≤2 neuropathy
  • Well-controlled hypo/hyperthyroidism or other endocrinopathies that are well controlled with hormone replacement
  • Subject has undergone a major surgery (excluding minor procedures e.g., placement of vascular access) \<2 months prior to administration of PRTH-101.
  • Subject has received radiation therapy \<28 days prior to administration of PRTH-101. a. Exception: limited (e.g., pain palliation) radiation therapy is allowed prior to and during study treatment as long as there are no acute toxicities, and the subject has measurable disease outside the radiation field.
  • Subject has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time.
  • Subject has a diagnosis of immunodeficiency, either primary or acquired.
  • Subject has received treatment with systemic steroids or any other form of immunosuppressive therapy within 14 days prior to administration of PRTH-101. a. Exception: inhaled or topical (to include mouthwash) steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.
  • Subject has an active or prior history of autoimmune disease requiring immunosuppressive therapy. Exceptions can be made in discussion with the medical monitor.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

  • Honor Health Research Institute — Scottsdale, Arizona
  • Yale Cancer Center — New Haven, Connecticut
  • Mass General Cancer Center — Boston, Massachusetts
  • Providence Cancer Institute Franz Clinic — Portland, Oregon
  • University of Pittsburgh Medical Center Hillman Cancer Center — Pittsburgh, Pennsylvania
  • Vanderbilt-Ingram Cancer Center — Nashville, Tennessee
  • The University of Texas MD Anderson Cancer Center — Houston, Texas
  • NEXT Houston — Houston, Texas
  • Next Oncology — Irving, Texas
  • NEXT Oncology — San Antonio, Texas
  • Next Oncology — Fairfax, Virginia

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗