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A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

NCT05753722•Incendia Therapeutics

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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. PRTH-101 is a therapeutic antibody that specifically binds to and blocks DDR1, a protein expressed on tumor cells that binds collagen to make a minimally permeable physical barrier that blocks immune cells from interacting with and attacking tumor cells. These "immune cell-excluded" solid tumors are resistant to attack by the immune system (as well as other existing therapies). By disabling DDR1, the collagen fibers lose alignment and loosen, creating gaps in the tumor barrier, thus allowing T-cells to enter and naturally attack the tumor. The main question\[s\] it aims to answer are: * to evaluate the safety and tolerability of PRTH-101 as mono therapy and in combination with pembrolizumab, * to determine the recommended Phase 2 dose as mono therapy and in combination with pembrolizumab, * to evaluate anti-tumor activity of PRTH-101 as mono therapy and in combination with pembrolizumab in selected indications

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject must be willing and able to read, understand, and sign an Informed Consent Form.
•2. Subject must be age ≥18 years.
•3. Subject has metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening, excluding hepatocellular carcinoma, sarcomas, and gliomas.
•4. Subject has a pathologically documented advanced/unresectable or metastatic cancer that is refractory to or intolerable to or the subject is unwilling or ineligible to receive standard treatment known to confer benefit or for which no standard treatment is available.
•5. Subject must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
•6. Subject must have a predicted life expectancy of ≥3 months.
•7. Subject must have the following laboratory values (obtained ≤14 days prior to enrollment):
•1. Calculated creatinine clearance must be ≥30 mL/min by Cockcroft-Gault formula calculation
•2. Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN)
•3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, or ≤3 x ULN in the presence of liver metastases
+11 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•1. Alopecia, and vitiligo
•2. Grade ≤2 neuropathy
•3. Well-controlled hypo/hyperthyroidism or other endocrinopathies that are well controlled with hormone replacement
•3. Subject has undergone a major surgery (excluding minor procedures e.g., placement of vascular access) \<2 months prior to administration of PRTH-101.
•4. 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.
•5. Subject has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time.
•6. Subject has a diagnosis of immunodeficiency, either primary or acquired.
+14 more criteria

Locations (11)

Honor Health Research Institute

Scottsdale, Arizona, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mass General Cancer Center

Boston, Massachusetts, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Houston

Houston, Texas, United States

Next Oncology

Irving, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

March 3, 2023

Primary Completion Date

September 30, 2027

Completion Date

September 30, 2027

Last Updated

February 23, 2026

Enrollment

270

ESTIMATED participants

Conditions

Advanced or Metastatic Solid TumorsNon Small Cell Lung CancerNSCLC

Interventions

PRTH-101

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Contacts

James Corkery

CONTACT

508-851-7690 james.corkery@incendiatx.com

Joseph Paul Eder, MD

CONTACT

857.777.6372 joseph.eder@incendiatx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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