Actively Recruiting
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Led by Incendia Therapeutics · Updated on 2026-02-23
270
Participants Needed
11
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to read, understand, and sign informed consent
- Age 18 years or older
- Metastatic or advanced, unresectable malignancy with measurable disease (excluding hepatocellular carcinoma, sarcomas, and gliomas)
- Advanced/unresectable or metastatic cancer refractory, intolerant, or ineligible for standard treatments
- Eastern Cooperative Oncology Group performance status 0-1
- Predicted life expectancy of at least 3 months
- Adequate laboratory values within 14 days prior to enrollment including creatinine clearance, bilirubin, liver enzymes, hemoglobin, platelets, neutrophil count, and QTc interval
- Negative pregnancy test for women of child-bearing potential within 3 days prior to first treatment
- Agreement to use birth control during and for 90 days after treatment for women of child-bearing potential and males with female partners
- Willingness to adhere to study visits and protocol restrictions
- Presence of a site of disease suitable for biopsy or availability of archived tissue
- Not enrolled in another clinical trial or receiving other cancer therapies
- Willingness to undergo pre- and post-treatment skin biopsies
You will not qualify if you...
- Prior systemic treatment with agents like radio-immunoconjugates, antibody-drug conjugates, cytokines, or monoclonal antibodies within 28 days or five half-lives
- Ongoing toxicity from prior therapy greater than Grade 1 except certain conditions like alopecia or controlled neuropathy
- Major surgery within 2 months prior to treatment
- Radiation therapy within 28 days prior to treatment except limited pain palliation without acute toxicity
- History or planned organ transplantation
- Diagnosis of immunodeficiency
- Treatment with systemic steroids or immunosuppressives within 14 days prior to treatment except inhaled or topical steroids without active autoimmune disease
- Active or prior autoimmune disease requiring immunosuppressive therapy without medical monitor approval
- Severe intolerance or allergy to monoclonal antibodies, Fc proteins, or study medications
- Untreated or active central nervous system tumor involvement or recent CNS symptoms
- Leptomeningeal carcinomatosis
- Current second malignancy at other sites except certain treated or indolent cancers
- Active significant infections including hepatitis or HIV
- Receipt of live vaccines within 30 days prior to treatment
- Pregnancy or breastfeeding
- Recent serious cardiac conditions within 6 months
- Contraindications to imaging or study procedures
- Medical or social conditions increasing risk, affecting compliance, or confounding study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
Mass General Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
5
University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Completed
6
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 27232
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
NEXT Houston
Houston, Texas, United States, 77054
Actively Recruiting
9
Next Oncology
Irving, Texas, United States, 75039
Actively Recruiting
10
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Next Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
J
James Corkery
CONTACT
J
Joseph Paul Eder, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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