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Checkpoint Inhibitor
TransCon TLR7/8 Agonist + Pembrolizumab for Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Ascendis Pharma Oncology Division A/S
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 average of two years
Awards & highlights
Study Summary
This trial is testing a new drug for solid tumors that is given as an injection into the tumor. The goal is to see if it is safe and what the best dose is.
Who is the study for?
Adults with advanced or metastatic solid tumors who have progressed after standard treatments, or for whom no standard care exists. They must not be pregnant, breastfeeding, HIV positive, or have active hepatitis B/C. Participants need resolved immune-related toxicities from prior therapies to ≤Grade 1 and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing TransCon TLR7/8 Agonist alone or combined with Pembrolizumab in patients with solid tumors. It involves injecting the drug directly into the tumor and aims to find the safest and most effective dose levels.See study design
What are the potential side effects?
Potential side effects include reactions at injection site, general inflammation due to immune response activation, fatigue, possible organ-specific inflammation related to pembrolizumab if used in combination therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average of two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average of two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose (RP2D)
Response
+1 moreSecondary outcome measures
Duration of Response
Event free survival (EFS) by RECIST 1.1 per investigator assessment
Overall Response Rate
+8 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 3 Phase 2 Combination Dose Expansion: TransCon TLR7/8 Agonist with PembrolizumabExperimental Treatment2 Interventions
TransCon TLR7/8 Agonist with Pembrolizumab using RP2D from Part 2 to evaluate safety/tolerability and anti-tumor activity of the combination in indication-specific dose expansion cohorts.
Group II: Part 2 Combination Dose Escalation and Optimization: TransCon TLR7/8 Agonist with PembrolizumabExperimental Treatment2 Interventions
TransCon TLR7/8 Agonist with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D.
Group III: Part 1 Monotherapy Dose Escalation and Optimization: TransCon TLR7/8 AgonistExperimental Treatment1 Intervention
TransCon TLR7/8 Agonist in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D.
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?
Ascendis Pharma Oncology Division A/SLead Sponsor
2 Previous Clinical Trials
485 Total Patients Enrolled
1 Trials studying Melanoma
393 Patients Enrolled for Melanoma
Gil NyamuswaStudy DirectorMedical Monitor
1 Previous Clinical Trials
393 Total Patients Enrolled
1 Trials studying Melanoma
393 Patients Enrolled for Melanoma
Joan MorrisStudy DirectorMedical Monitor
2 Previous Clinical Trials
152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder that makes certain cancer tests risky for me.I have at least 2 measurable cancer lesions.I have an autoimmune disease but it's under control with hormone replacement therapy.I have not had any other cancers in the last 2 years.Any side effects from previous immune therapy have mostly gone away.I am not on strong immune-suppressing drugs, except for low-dose steroids.I have brain metastases causing symptoms.My condition worsened after standard treatments or no standard treatments are available for me.I've had anti-PD-1, anti-PD-L1, or anti-CTLA 4 treatment over 4 weeks ago and my cancer has progressed.I have not received any live vaccines in the last 4 weeks.I have not been treated with TLR agonists, except for topical ones for a different condition.I haven't had cancer treatment or radiation in the last 4 weeks.I am allergic to ingredients in TransCon TLR7/8 Agonist or pembrolizumab.I do not have any untreated infections.I am HIV positive or have an active hepatitis B or C infection.I have risk factors for a specific heart rhythm problem (like heart failure or low potassium).I am 18 years old or older.I haven't taken any medications that affect my heart's rhythm in the last 14 days.I have a serious heart condition.My heart's electrical cycle is longer than usual.My organs are functioning well as of a recent check.My cancer is advanced and cannot be cured with surgery or radiation.I am able to care for myself and perform daily activities.I am willing to have biopsies done.I agree to use effective birth control if I can have children and am sexually active.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Monotherapy Dose Escalation and Optimization: TransCon TLR7/8 Agonist
- Group 2: Part 2 Combination Dose Escalation and Optimization: TransCon TLR7/8 Agonist with Pembrolizumab
- Group 3: Part 3 Phase 2 Combination Dose Expansion: TransCon TLR7/8 Agonist 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.
What has research indicated TransCon TLR7/8 Agonist is beneficial in treating?
"TransCon TLR7/8 Agonist is frequently utilized to treat malignant neoplasms. It has also been found to be helpful in mitigating the effects of conditions such as microsatellite instability high, unresectable melanoma, and post-chemotherapy disease progression."
Answered by AI
Are there many research centers running this investigation in the city?
"Ten medical facilities are currently running this trial, with prominent locations in Chicago, Fairfax and Pittsburgh. To reduce the burden of travel for participants, it is wise to select a center located proximally from your residence."
Answered by AI
Is this trial currently accepting new participants?
"Affirmative. Data posted on clinicaltrials.gov demonstrates that this medical investigation is presently enrolling subjects, having been originally shared on March 18th 2021 and updated most recently in September 21st 2022. The trial requires 220 patients to be recruited from 10 different locations."
Answered by AI
What is the current participant count in this research endeavor?
"Indeed, recent data hosted on clinicaltrials.gov affirms that this medical trial is presently seeking patients. It was first announced on March 18th 2021 and most recently updated on September 21st 2022. The research requires 220 test subjects spread across 10 locations to complete the study."
Answered by AI
Could you elaborate on the research conducted with TransCon TLR7/8 Agonist?
"At this time, a total of 961 clinical trials are underway that focus on TransCon TLR7/8 Agonist. Out of those investigations, 122 have entered Phase 3. Despite the majority being located in Houston, Texas; 35731 other locations around the world have associated studies for this medicinal approach."
Answered by AI
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