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Chemotherapy

TransCon IL-2 β/γ + Pembrolizumab/Chemotherapy for Solid Tumor Cancers (IL Believe Trial)

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
Participants must have histologically confirmed locally advanced, recurrent, or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of the neoadjuvant cohorts
Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

IL Believe Trial Summary

This trial is testing a new drug, TransCon IL-2 β/γ, to treat various solid tumors. The trial will test how well the drug works and what side effects it may have.

Who is the study for?
Adults with advanced solid tumors who are at least 18, have good organ function and a life expectancy over 12 weeks. They must not be pregnant or breastfeeding, agree to contraception if of childbearing potential, and have no severe allergies to study drugs or significant health issues like uncontrolled infections or heart disease.Check my eligibility
What is being tested?
The trial is testing TransCon IL-2 β/γ alone or combined with Pembrolizumab and/or chemotherapy in adults with advanced solid tumors. It's an early-phase study assessing different doses to find the safest and most effective levels for treatment.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to TransCon IL-2 β/γ or Pembrolizumab, such as inflammation in various organs, infusion-related reactions, fatigue, digestive problems, skin changes, and increased risk of infections.

IL Believe Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced and cannot be cured with surgery or radiation, except as part of initial treatment.
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I can care for myself and am up and about more than 50% of my waking hours.
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My cancer can be entirely removed with surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.

IL Believe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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)
Safety and Tolerability
Secondary outcome measures
Duration of Response
Event free survival (EFS) by RECIST 1.1
Major Pathologic Response
+10 more

IL Believe Trial Design

10Treatment groups
Experimental Treatment
Group I: Part 4 Combination Dose OptimizationExperimental Treatment2 Interventions
TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab
Group II: Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgeryExperimental Treatment2 Interventions
(Optional Arm): TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Group III: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgeryExperimental Treatment3 Interventions
TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Group IV: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgeryExperimental Treatment4 Interventions
TransCon IL-2 β/γ using the RP2D with Pembrolizumab and SOC Chemotherapy followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Group V: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 AgonistExperimental Treatment2 Interventions
TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination
Group VI: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC ChemoExperimental Treatment2 Interventions
TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination
Group VII: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgeryExperimental Treatment3 Interventions
TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Group VIII: Part 3 Combination Dose ExpansionExperimental Treatment2 Interventions
TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab
Group IX: Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with PembrolizumabExperimental Treatment2 Interventions
TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D
Group X: Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γExperimental Treatment1 Intervention
TransCon IL-2 β/γ 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
Surgery
2000
Completed Phase 3
~2550
Chemotherapy drug
2020
N/A
~70

Find a Location

Who is running the clinical trial?

Ascendis Pharma Oncology Division A/SLead Sponsor
2 Previous Clinical Trials
312 Total Patients Enrolled
Ascendis Pharma A/SLead Sponsor
11 Previous Clinical Trials
1,164 Total Patients Enrolled
Davis Torrejon-CastroStudy DirectorMedical Monitor

Media Library

Chemotherapy drug (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05081609 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Part 3 Combination Dose Expansion, Part 4 Combination Dose Optimization, Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery, Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery, Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab, Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo, Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist, Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery, Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery, Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
Ovarian Cancer Clinical Trial 2023: Chemotherapy drug Highlights & Side Effects. Trial Name: NCT05081609 — Phase 1 & 2
Chemotherapy drug (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081609 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the previous findings regarding this Chemotherapy medication?

"City of Hope first conducted research on this chemotherapy drug in 2010. In the decade since, there have been 348 completed trials and presently 1000 active ones. A majority of these latter studies are based in Huntersville, North carolina."

Answered by AI

Are we still looking for more participants for this clinical trial?

"That is correct. The online clinicaltrials.gov registry shows that this research project, which was first advertised on 1/11/2022, is still looking for participants. There are 5 different enrolling locations and the goal is to have 317 people enrolled in total."

Answered by AI

What is the maximum patient limit for this clinical trial?

"The listing on clinicaltrials.gov reveals that this research is actively looking for participants. The study was made public on 1/11/2022, with the most recent update being 11/16/2022. They are currently 317 patients needed between 5 sites."

Answered by AI

For what purpose is chemotherapy most often prescribed?

"Chemotherapy drugs are used to kill cancer cells. They are also sometimes effective in treating other conditions, such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Why was this clinical trial originally designed and what benefits are researchers hoping to achieve?

"The primary outcome measure for this study, which will be observed over the course of 12 months, is safety and tolerability. Additionally, researchers will secondary outcomes including pathologic complete response, pharmacokinetic characterization, and event-free survival."

Answered by AI

Across how many states is this research being conducted?

"Choosing a location for this clinical trial that is nearest to you is ideal, as there are currently 5 sites running the study and travel might be demanding. The locations of these trials are in Huntersville, Canton, Cincinnati and other places."

Answered by AI
~193 spots leftby May 2026