A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies (IL Believe)

February 23, 2026 updated by: Ascendis Pharma Oncology Division A/S

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

IL-2 is a key cytokine that directs the immune system through pleiotropic effects mediated by promoting expansion of both cytotoxic effector cells and Tregs. TransCon IL-2 β/γ is designed as a long-acting delivery prodrug of IL-2 β/γ, a potent cytokine signaling molecule, with the potential to improve the safety and efficacy of IL-2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Ascendis Pharma Investigational Site
      • Adelaide, Australia, 5042
        • Ascendis Pharma Investigational Site
      • Brisbane, Australia, 04120
        • Ascendis Pharma Investigational Site
      • Frankston, Australia, 3199
        • Ascendis Pharma Investigational Site
      • Southport, Australia, 4215
        • Ascendis Pharma Investigational Site
      • Toorak Gardens, Australia, 05065
        • Ascendis Pharma Investigational Site
      • Waratah, Australia, 2298
        • Ascendis Pharma Investigational Site
  • Belgium
      • Wilrijk, Belgium, 2610
        • Ascendis Pharma Investigational Site
  • Canada
      • Montreal, Canada, H4A 3J1
        • Ascendis Pharma Investigational Site
      • Toronto, Canada, M4N 3M5
        • Ascendis Pharma Investigational Site
      • Toronto, Canada, M5G 2C4
        • Ascendis Pharma Investigational Site
  • Italy
      • Cuneo, Italy, 12100
        • Ascendis Pharma Investigational Site
      • Florence, Italy, 50134
        • Ascendis Pharma Investigational Site
      • Grosseto, Italy, 58100
        • Ascendis Pharma Investigational Site
      • Lido di Camaiore, Italy, 55041
        • Ascendis Pharma Investigational Site
      • Livorno, Italy, 57124
        • Ascendis Pharma Investigational Site
      • Meldola, Italy, 47014
        • Ascendis Pharma Investigational Site
      • Milan, Italy, 20133
        • Ascendis Pharma Investigational Site
      • Milan, Italy, 20141
        • Ascendis Pharma Investigational Site
      • Modena, Italy, 41124
        • Ascendis Pharma Investigational Site
      • Roma, Italy, 00167
        • Ascendis Pharma Investigational Site
      • Torino, Italy, 10126
        • Ascendis Pharma Investigational Site
      • Turin, Italy, 10060
        • Ascendis Pharma Investigational Site
      • Verona, Italy, 37134
        • Ascendis Pharma Investigational Site
  • Poland
      • Krakow, Poland, 31-501
        • Ascendis Pharma Investigational Site
      • Poznan, Poland, 60693
        • Ascendis Pharma Investigational Site
      • Warsaw, Poland, 02-781
        • Ascendis Pharma Investigational Site
  • Singapore
      • Singapore, Singapore, 119228
        • Ascendis Pharma Investigational Site
      • Singapore, Singapore, 217562
        • Ascendis Pharma Investigational Site
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Ascendis Pharma Investigational Site
      • Seoul, South Korea, 03080
        • Ascendis Pharma Investigational Site
      • Seoul, South Korea, 03722
        • Ascendis Pharma Investigational Site
      • Seoul, South Korea, 06231
        • Ascendis Pharma Investigational Site
      • Seoul, South Korea, 06351
        • Ascendis Pharma Investigational Site
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea, 05505
        • Ascendis Pharma Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Ascendis Pharma Investigational Site
      • Barcelona, Spain, 08023
        • Ascendis Pharma Investigational Site
      • Barcelona, Spain, 08028
        • Ascendis Pharma Investigational Site
      • L'Hospitalet de Llobregat, Spain, 08908
        • Ascendis Pharma Investigational Site
      • Madrid, Spain, 28006
        • Ascendis Pharma Investigational Site
      • Madrid, Spain, 28027
        • Ascendis Pharma Investigational Site
      • Madrid, Spain, 28040
        • Ascendis Pharma Investigational Site
      • Madrid, Spain, 28041
        • Ascendis Pharma Investigational Site
      • Madrid, Spain, 28050
        • Ascendis Pharma Investigational Site
      • Murcia, Spain, 30120
        • Ascendis Pharma Investigational Site
      • Málaga, Spain, 29010
        • Ascendis Pharma Investigational Site
      • Oviedo, Spain, 33011
        • Ascendis Pharma Investigational Site
      • Pamplona, Spain, 31008
        • Ascendis Pharma Investigational Site
      • Seville, Spain, 41009
        • Ascendis Pharma Investigational Site
      • Seville, Spain, 41014
        • Ascendis Pharma Investigational Site
      • Valencia, Spain, 46009
        • Ascendis Pharma Investigational Site
      • Valencia, Spain, 46014
        • Ascendis Pharma Investigational Site
  • Taiwan
      • Taipei, Taiwan, 10002
        • Ascendis Pharma Investigational Site
      • Taipei, Taiwan, 11259
        • Ascendis Pharma Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Ascendis Pharma Investigational Site
      • Los Angeles, California, United States, 90067
        • Ascendis Pharma Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Ascendis Pharma Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Ascendis Pharma Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ascendis Pharma Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Ascendis Pharma Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Ascendis Pharma Investigational Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Ascendis Pharma Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Ascendis Pharma Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Ascendis Pharma Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Ascendis Pharma Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Ascendis Pharma Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Ascendis Pharma Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Ascendis Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • At least 18 years of age, or country defined local legal age
  • Demonstrated adequate organ function at screening
  • Life expectancy >12 weeks as determined by the Investigator
  • Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception
  • 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
  • Part 3 and Part 4: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) antibody must have a washout of at least 4 weeks from the last dose and evidence of disease progression per investigator assessment before Cycle 1 Day 1 (C1D1) with the exception of the neoadjuvant cohorts
  • Participants who have previously received an immunotherapy prior to C1D1 must have any immune-related toxicities resolved to ≤Grade 1 or baseline (prior to the immunotherapy) to be eligible, with the exception of participants on well controlled physiologic endocrine replacement
  • Part 3: Neoadjuvant cohorts: participants must have completely resectable disease

Key Exclusion Criteria:

  • Symptomatic central nervous system metastases and/or carcinomatous meningitis
  • Active autoimmune diseases, regardless of need for immunosuppressive treatment, with the exception of participants well controlled on physiologic endocrine replacement
  • Any uncontrolled bacterial, fungal, viral, or other infection
  • Significant cardiac disease
  • A marked clinically significant baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 ms) [CTCAE Grade 1]) using Fridericia's QT correction formula
  • Positive for human immunodeficiency virus (HIV) or has known active hepatitis B or C infection
  • Known hypersensitivity to any study treatment(s) used in the specific study part/cohort
  • Participants who have been previously treated with IL-2 or IL-2 variants (all participants)
  • Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation).
  • Vaccination with live, attenuated vaccines within 4 weeks of C1D1
  • Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of C1D1
  • Part 3: Other active malignancies within the last 2 years
  • Women who are breastfeeding or have a positive serum pregnancy test during screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ
TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Experimental: Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab
TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo
TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Chemotherapy drug
SOC chemotherapy will be administered as an intravenous (IV) infusion
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist
TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: TransCon TLR7/8 Agonist
TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery
TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion
Procedure: Surgery
Surgery will take place 4-6 weeks after last dose of study treatment.
Experimental: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery
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
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: TransCon TLR7/8 Agonist
TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection
Procedure: Surgery
Surgery will take place 4-6 weeks after last dose of study treatment.
Experimental: Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery
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
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion
Drug: Chemotherapy drug
SOC chemotherapy will be administered as an intravenous (IV) infusion
Procedure: Surgery
Surgery will take place 4-6 weeks after last dose of study treatment.
Experimental: Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery
(Optional Arm): TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Procedure: Surgery
Surgery will take place 4-6 weeks after last dose of study treatment.
Experimental: Part 3 Combination Dose Expansion
TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion
Experimental: Part 4 Combination Dose Optimization
TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ monotherapy
TransCon IL-2 β/γ monotherapy
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab
TransCon IL-2 β/γ + trastuzumab
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Trastuzumab
Trastuzumab will be administered as an intravenous (IV) infusion
Experimental: Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)
TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1)
Drug: TransCon IL-2 β/γ
TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion
Drug: Trastuzumab emtansine (T-DM1)
Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Through study completion, expected average of 2 years
Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.
Through study completion, expected average of 2 years
Maximum Tolerated Dose (MTD)
Time Frame: Each cycle is 21 days
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
Each cycle is 21 days
Recommended Phase 2 Dose (RP2D)
Time Frame: 12 months
To determine a recommended phase 2 dose of TransCon IL-2 β/γ and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Average of 2 years
Response assessed by RECIST v1.1
Average of 2 years
Pathologic Complete Response
Time Frame: 15 weeks
Evaluate the pathologic Complete Response (pCR) for anti-tumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy in the Neoadjuvant Cohorts
15 weeks
Major Pathologic Response
Time Frame: 15 weeks
Evaluate the Major Pathologic Response (MPR) for anti-tumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy in the Neoadjuvant Cohorts
15 weeks
Duration of Response
Time Frame: Average of 2 years
Time from first documentation of objective tumor response (CR or PR that is subsequently confirmed) to first documentation of disease progression or death due to any cause, whichever occurs first
Average of 2 years
Time to Response
Time Frame: Expected up to 1 year from first dose
Time from date of first dose of study treatment to first occurrence of response (CR or PR)
Expected up to 1 year from first dose
Progression Free Survival (PFS)
Time Frame: Average of 2 years
Time from date of first dose of study treatment to first documentation of disease progression or death due to any cause
Average of 2 years
Event free survival (EFS) by RECIST 1.1
Time Frame: 2 years
Time from the date of the first dose of study treatment to the occurrence of any of the following: progression of disease that precludes surgery, disease recurrence after surgery, or death from any cause.
2 years
Overall Survival (OS)
Time Frame: Average of 2 years
Time from date of first dose of study treatment to date of death due to any cause
Average of 2 years
PK Characterization (Cmax)
Time Frame: Average of 2 years
Maximum observed plasma concentration of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Average of 2 years
PK Characterization (Tmax)
Time Frame: Average of 2 years
Time to reach maximum plasma concentration of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination other therapies
Average of 2 years
PK Characterization (AUClast)
Time Frame: Average of 2 years
Area under the plasma concentration curve from time zero to last sampling time at which the concentration is at or above the lower limit of quantification for TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Average of 2 years
PK Characterization (AUC0-t)
Time Frame: Average of 2 years
Area under the plasma concentration curve from time zero to time t for TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Average of 2 years
PK Characterization (t1/2)
Time Frame: Average of 2 years
Apparent terminal half-life of TransCon IL-2 β/γ and Free IL-2 β/γ after IV administration of TransCon IL-2 β/γ alone or in combination with other therapies
Average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascendis Pharma Oncology Division A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Davis Torrejon-Castro, Medical Monitor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASND0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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