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New immune drug shows promise in early trial for Hard-to-Treat cancers

NCT ID NCT05081609

Disease control Sponsor: Ascendis Pharma Oncology Division A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests an experimental drug called TransCon IL-2 β/γ, which aims to boost the immune system to fight cancer. It is given alone or with other treatments like pembrolizumab (Keytruda) or chemotherapy. The trial includes 320 adults with advanced solid tumors that have not responded to standard care. The main goals are to check safety and find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TransCon IL-2 β/γ (an experimental immune-boosting drug)
What this could lead to
If successful, this could provide a new treatment option for several advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (first in humans), so safety and effectiveness are not yet proven. The drug may cause significant side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

320 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma HER2 positive breast carcinoma melanoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer ovarian carcinoma small cell lung carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

2L+ cervical cancer Advanced solid tumor Locally advanced solid tumor Metastatic solid tumor Neoadjuvant melanoma Neoadjuvant non-small cell lung cancer Platinum-resistant ovarian cancer Post anti-PD-(L)1 non-small cell lung cancer Post anti-PD-(L)1 small cell lung cancer Post anti-PD-1 melanoma Second or third line (2L/3L) cervical cancer Third line or later (3L+) HER2+ breast cancer Third-line or later (3L+) platinum-resistant ovarian cancer (PROC)

Contacts and locations

Locations

  • Ascendis Pharma Investigational Site

    Los Angeles, California, 90048, United States

  • Ascendis Pharma Investigational Site

    Los Angeles, California, 90067, United States

  • Ascendis Pharma Investigational Site

    Springfield, Illinois, 62702, United States

  • Ascendis Pharma Investigational Site

    Louisville, Kentucky, 40202, United States

  • Ascendis Pharma Investigational Site

    Boston, Massachusetts, 02114, United States

  • Ascendis Pharma Investigational Site

    Morristown, New Jersey, 07960, United States

  • Ascendis Pharma Investigational Site

    New York, New York, 10032, United States

  • Ascendis Pharma Investigational Site

    Huntersville, North Carolina, 28078, United States

  • Ascendis Pharma Investigational Site

    Canton, Ohio, 44718, United States

  • Ascendis Pharma Investigational Site

    Cincinnati, Ohio, 45219, United States

  • Ascendis Pharma Investigational Site

    Oklahoma City, Oklahoma, 73104, United States

  • Ascendis Pharma Investigational Site

    Pittsburgh, Pennsylvania, 15232, United States

  • Ascendis Pharma Investigational Site

    Nashville, Tennessee, 37203, United States

  • Ascendis Pharma Investigational Site

    Richmond, Virginia, 23298, United States

  • Ascendis Pharma Investigational Site

    Adelaide, 5000, Australia

  • Ascendis Pharma Investigational Site

    Adelaide, 5042, Australia

  • Ascendis Pharma Investigational Site

    Brisbane, 04120, Australia

  • Ascendis Pharma Investigational Site

    Frankston, 3199, Australia

  • Ascendis Pharma Investigational Site

    Southport, 4215, Australia

  • Ascendis Pharma Investigational Site

    Toorak Gardens, 05065, Australia

  • Ascendis Pharma Investigational Site

    Waratah, 2298, Australia

  • Ascendis Pharma Investigational Site

    Wilrijk, 2610, Belgium

  • Ascendis Pharma Investigational Site

    Montreal, H4A 3J1, Canada

  • Ascendis Pharma Investigational Site

    Toronto, M4N 3M5, Canada

  • Ascendis Pharma Investigational Site

    Toronto, M5G 2C4, Canada

  • Ascendis Pharma Investigational Site

    Cuneo, 12100, Italy

  • Ascendis Pharma Investigational Site

    Florence, 50134, Italy

  • Ascendis Pharma Investigational Site

    Grosseto, 58100, Italy

  • Ascendis Pharma Investigational Site

    Lido di Camaiore, 55041, Italy

  • Ascendis Pharma Investigational Site

    Livorno, 57124, Italy

  • Ascendis Pharma Investigational Site

    Meldola, 47014, Italy

  • Ascendis Pharma Investigational Site

    Milan, 20133, Italy

  • Ascendis Pharma Investigational Site

    Milan, 20141, Italy

  • Ascendis Pharma Investigational Site

    Modena, 41124, Italy

  • Ascendis Pharma Investigational Site

    Roma, 00167, Italy

  • Ascendis Pharma Investigational Site

    Torino, 10126, Italy

  • Ascendis Pharma Investigational Site

    Turin, 10060, Italy

  • Ascendis Pharma Investigational Site

    Verona, 37134, Italy

  • Ascendis Pharma Investigational Site

    Krakow, 31-501, Poland

  • Ascendis Pharma Investigational Site

    Poznan, 60693, Poland

  • Ascendis Pharma Investigational Site

    Warsaw, 02-781, Poland

  • Ascendis Pharma Investigational Site

    Singapore, 119228, Singapore

  • Ascendis Pharma Investigational Site

    Singapore, 217562, Singapore

  • Ascendis Pharma Investigational Site

    Seoul, Songpa-gu, 05505, South Korea

  • Ascendis Pharma Investigational Site

    Seongnam-si, 13620, South Korea

  • Ascendis Pharma Investigational Site

    Seoul, 03080, South Korea

  • Ascendis Pharma Investigational Site

    Seoul, 03722, South Korea

  • Ascendis Pharma Investigational Site

    Seoul, 06231, South Korea

  • Ascendis Pharma Investigational Site

    Seoul, 06351, South Korea

  • Ascendis Pharma Investigational Site

    Barcelona, 08023, Spain

  • Ascendis Pharma Investigational Site

    Barcelona, 08028, Spain

  • Ascendis Pharma Investigational Site

    Barcelona, 08035, Spain

  • Ascendis Pharma Investigational Site

    L'Hospitalet de Llobregat, 08908, Spain

  • Ascendis Pharma Investigational Site

    Madrid, 28006, Spain

  • Ascendis Pharma Investigational Site

    Madrid, 28027, Spain

  • Ascendis Pharma Investigational Site

    Madrid, 28040, Spain

  • Ascendis Pharma Investigational Site

    Madrid, 28041, Spain

  • Ascendis Pharma Investigational Site

    Madrid, 28050, Spain

  • Ascendis Pharma Investigational Site

    Málaga, 29010, Spain

  • Ascendis Pharma Investigational Site

    Murcia, 30120, Spain

  • Ascendis Pharma Investigational Site

    Oviedo, 33011, Spain

  • Ascendis Pharma Investigational Site

    Pamplona, 31008, Spain

  • Ascendis Pharma Investigational Site

    Seville, 41009, Spain

  • Ascendis Pharma Investigational Site

    Seville, 41014, Spain

  • Ascendis Pharma Investigational Site

    Valencia, 46009, Spain

  • Ascendis Pharma Investigational Site

    Valencia, 46014, Spain

  • Ascendis Pharma Investigational Site

    Taipei, 10002, Taiwan

  • Ascendis Pharma Investigational Site

    Taipei, 11259, Taiwan

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