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Virus Therapy
PRTH-101 + Pembrolizumab for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Incendia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial tests if a new drug combo is safe and works to treat advanced cancer in adults.
Who is the study for?
Adults with advanced or metastatic solid tumors who have not responded to standard treatments, are ineligible for them, or do not wish to receive them. Participants must be over 18, in good physical condition (ECOG PS 0-1), and have a life expectancy of at least 3 months. They should not be on other cancer trials or treatments and must agree to use birth control. People with certain medical conditions, recent surgeries, ongoing toxicity from past therapies above Grade 1 (except specific cases), active infections like hepatitis or HIV, unstable heart disease, CNS tumor involvement that's untreated/active within the last month are excluded.Check my eligibility
What is being tested?
The trial is testing PRTH-101 alone or combined with pembrolizumab in adults with various types of advanced cancers. It aims to assess how safe these treatments are and how well patients tolerate them. The study is open-label which means everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system since both drugs work by activating it against cancer cells; this can sometimes cause inflammation in different parts of the body. Other common side effects might involve fatigue, skin reactions due to biopsies required by the study protocol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anti-tumor activity of PRTH-101 alone and in combination with pembrolizumab
Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with PRTH-101
Maximum Tolerated Dose
+1 moreSecondary outcome measures
To define the PK profile of PRTH-101 together with pembrolizumab
To evaluate the PK of pembrolizumab
To evaluate the incidence and persistence of anti- PRTH-101 antibody formation and its impact on the PK profile of PRTH-101 in combination with pembrolizumab antibody therapy
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PRTH-101 with PembrolizumabExperimental Treatment2 Interventions
Combo therapy
Group II: PRTH-101Experimental Treatment1 Intervention
Mono-therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Incendia TherapeuticsLead Sponsor
Parthenon Therapeutics, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer at more than one site in my body.I can carry out all my usual activities without help.I do not have any serious infections, including Hepatitis or HIV.I've had treatments like immunotherapy or targeted therapy within the last month.I have had or will have an organ or stem-cell transplant.I have been diagnosed with an immune system disorder.I am only using inhaled or topical steroids, not for an active autoimmune disease.I haven't taken steroids or immunosuppressants in the last 14 days.I am 18 years old or older.I received radiation therapy less than 28 days before starting PRTH-101.I am not pregnant or breastfeeding.My brain or spinal cord tumor is active and hasn't been fully treated with surgery or radiation.My advanced cancer cannot be surgically removed, and standard treatments are not suitable for me.My cancer has spread to the lining of my brain and spinal cord.I've had some radiation therapy but no recent side effects and my cancer can still be measured outside the treated area.I had major surgery less than 2 months ago.I can have a biopsy or have tissue samples available.I have not received any live vaccines in the last 30 days.I have or had an autoimmune disease treated with immunosuppressants.I have mild side effects from previous treatments, except for hair loss, skin changes, mild nerve pain, or thyroid issues which are under control.My cancer is advanced, cannot be surgically removed, and can be measured by specific criteria, but it's not liver cancer, sarcoma, or brain tumor.I haven't had serious heart or stroke issues in the last 6 months.I am willing to have skin biopsies before and after treatment.I am not in another clinical trial or receiving other cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: PRTH-101
- Group 2: PRTH-101 with Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available to prospective participants at this time?
"As indicated by clinicaltrials.gov, this medical investigation has opened recruitment opportunities for participants. It was published on March 3rd 2023 and the most recent update happened on April 25th of the same year."
Answered by AI
How many individuals are actively involved in this clinical trial?
"Affirmative. According to the information stored on clinicaltrials.gov, this medical study was first posted on March 3rd 2023 and remains in active recruitment mode. 270 patients are being sought from 1 site for participation in this trial."
Answered by AI
Has the PRTH-101 and Pembrolizumab combination obtained clearance from the Food & Drug Administration?
"The safety of PRTH-101 with Pembrolizumab has been tentatively assessed as a 1 due to the limited data available from Phase 1 research."
Answered by AI
What is the primary aim of this experiment?
"This trial will be monitored for up to 4 years and aims to assess the adverse effects (AEs) of PRTH-101, including any serious AE that may occur. Other objectives include determining antibody formation in serum levels over multiple timepoints and its effect on PK profile when combined with pembrolizumab therapy, analyzing PK parameters such as half-life of plasma concentration of a drug, and defining the overall PK profile when taken alongside pembrolizumab therapy."
Answered by AI
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