Actively Recruiting
Open-Label Phase 1 Study of PRTH-101 Alone or with Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
Led by Incendia Therapeutics · Updated on 2026-02-23
270
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of PRTH-101, alone or combined with pembrolizumab, in adults with advanced or metastatic solid tumors that are difficult to treat. PRTH-101 is a specialized antibody designed to block DDR1, a protein on tumor cells that creates a barrier preventing immune cells from attacking the tumor. This study aims to find safe doses and observe anti-tumor activity of PRTH-101 both alone and with pembrolizumab. Participants will receive either PRTH-101 alone or in combination with pembrolizumab in an open-label setting, meaning both the researchers and participants know the treatment given. The study includes dose escalation and expansion phases to determine the best dose and assess the effects. Treatment schedules and doses will be monitored over time to evaluate safety and how the drugs behave in the body. During the trial, participants will undergo regular assessments including safety monitoring for adverse events, pharmacokinetic testing to measure drug levels, and evaluations of tumor response. Biopsies of tumors and skin will be performed before and after treatment to study drug effects. The study will last up to four years, with ongoing monitoring of side effects, immune response, and anti-tumor activity throughout this period.
CONDITIONS
Brief 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...
- Age 18 years or older
- Willing and able to understand and sign informed consent
- Diagnosed with metastatic or advanced unresectable solid tumor excluding hepatocellular carcinoma, sarcomas, and gliomas
- Cancer refractory, intolerable to, or ineligible for standard treatments
- Eastern Cooperative Oncology Group performance status 0-1
- Predicted life expectancy of at least 3 months
- Meet specific laboratory value requirements including kidney, liver function, blood counts, and heart rhythm
- Women of child-bearing potential must have a negative pregnancy test before treatment
- Agree to use adequate birth control during and 90 days after treatment
- Willing to adhere to study visit schedule and restrictions
- Have disease site suitable for biopsy or available archived tissue
- Not enrolled in another clinical trial or receiving other malignancy treatments
- Willing to undergo pre- and post-treatment skin biopsies
You will not qualify if you...
- Received systemic cancer treatments or monoclonal antibodies within 28 days before study drug
- Ongoing toxicity from prior therapy above grade 1 except specified conditions
- Major surgery within 2 months prior to treatment
- Radiation therapy within 28 days before treatment except limited palliation
- History of organ or stem-cell transplantation
- Immunodeficiency diagnosis
- Systemic steroids or immunosuppressive therapy within 14 days prior except certain exceptions
- Active or prior autoimmune disease needing immunosuppressive therapy unless approved
- Severe intolerance or allergy to monoclonal antibodies or study medications
- Untreated or active central nervous system tumor involvement
- Leptomeningeal carcinomatosis
- Current second malignancy except certain treated cancers
- Active significant infections including hepatitis or HIV
- Received live vaccines within 30 days prior to treatment
- Pregnant or breastfeeding women
- Recent serious heart conditions within 6 months prior
- Contraindications to imaging or study procedures
- Medical or social conditions increasing risk or affecting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 4 years
Participants receive PRTH-101 alone or in combination with pembrolizumab to evaluate safety, tolerability, and anti-tumor activity.
Regular visits during treatment for dosing and safety assessments
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
J
Joseph Paul Eder, MD
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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