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Experimental cancer drug trial halted early

NCT ID NCT04799054

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an investigational drug called TransCon TLR7/8 agonist, alone or with the immunotherapy pembrolizumab, in people with advanced solid tumors that could not be cured by surgery or radiation. The study aimed to find a safe dose and check for side effects. However, the trial was terminated before completion, so its full results are not available.

What this could mean

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

Active substance
TransCon TLR7/8 agonist (an investigational drug that activates the immune system) and pembrolizumab (an immunotherapy drug)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This trial was terminated early, so results are limited. It was an early-phase study focused on safety and dosing, not yet on effectiveness. The drug may cause 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

188 people

The number who actually took part.

Started

Mar 2021

Finished

Dec 2025

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.

Inclusion Criteria: * At least 18 years of age. * Participants must have histologically confirmed locally advanced, recurrent or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy). * Participants must have progressed on or be intolerant of available standard of care treatment options or have disease for which there is no standard of care treatment available, with the exception of participants enrolling to the neoadjuvant cohorts. * At least 2 lesions of measurable disease, unless specified otherwise in the selection criteria. * Willingness to undergo biopsies. * Demonstrated adequate organ function within 28 days of Cycle 1 Day 1 (C1D1). * Life expectancy \>12 weeks as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. * Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or antiCTLA 4 antibody must have at least 4 weeks from the last dose of antibody and evidence of disease progression per investigator assessment before enrollment. * Participants who have previously received an immune checkpoint inhibitor prior to enrollment must have any immune related toxicities resolved to ≤Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible. * Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception. Exclusion Criteria: * Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible. * Other active malignancies within the last 2 years are excluded. * Active autoimmune diseases, regardless of need for immunosuppressive treatment at the time of screening, with the exception of patients well controlled on physiologic endocrine replacement. * Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation). Participants cannot start dosing on study until steroid dose is at or lower than 10 mg per day prednisone or equivalent. * Women who are breastfeeding or have a positive serum pregnancy test during screening or within 72 hours prior to C1D1 are not eligible. * Vaccination with live, attenuated vaccines within 4 weeks of enrollment. * Symptomatic central nervous system metastases. * Known bleeding disorder that is deemed to place the patient at unacceptable risk for bleeding complications from intratumoral injections or biopsies. * Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab. * Any uncontrolled bacterial, fungal, viral, or other infection. * Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed. * Significant cardiac disease * A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval \>480 ms (National Cancer Institute NCI) Common Terminology Criteria for Adverse Events \[CTCAE\] grade 1) using Fredericia's QT correction formula. * A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome). * The use of concomitant medications that prolong the QT/QTc interval within 14 days of enrollment. * Positive for HIV or with active hepatitis B or C infection.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma melanoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis skin squamous cell carcinoma

As listed by the trial registrant

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

Advanced solid tumor Head and neck squamous cell carcinoma HNSCC HPV associated cancers Locally advanced solid tumor Metastatic solid tumor Neoadjuvant cutaneous squamous cell carcinoma (CSCC) Neoadjuvant melanoma

Contacts and locations

Locations

  • Ascendis Investigational Site

    Los Angeles, California, 90067, United States

  • Ascendis Investigational Site

    Orange, California, 92868, United States

  • Ascendis Investigational Site

    Tampa, Florida, 33612, United States

  • Ascendis Investigational Site

    Dallas, Texas, 75235, United States

  • Ascendis Investigational Site

    Dallas, Texas, 75390, United States

  • Ascendis Investigational Site

    Houston, Texas, 77030, United States

  • Ascendis Investigational Site

    Bedford Park, 5042, Australia

  • Ascendis Investigational Site

    Amsterdam, 1066, Netherlands

  • Ascendis Investigational Site

    Rotterdam, 3015 GD, Netherlands

  • Ascendis Investigational Site

    Dalseo-gu, 42601, South Korea

  • Ascendis Investigational Site

    Seocho-gu, 06591, South Korea

  • Ascendis Investigational Site

    Seogu, 49201, South Korea

  • Ascendis Investigational Site

    Seogu, 49267, South Korea

  • Ascendis Investigational Site

    Seongnam, 13620, South Korea

  • Ascendis Investigational Site

    Seoul, 03722, South Korea

  • Ascendis Investigational Site

    Seoul, 05505, South Korea

  • Ascendis Investigational Site

    Seoul, 06273, South Korea

  • Ascendis Investigational Site

    Suwon, 16247, South Korea

  • Ascendis Investigational Site

    Suwon, 16499, South Korea

  • Ascendis Investigational Site

    Barcelona, 08003, Spain

  • Ascendis Investigational Site

    Barcelona, 08028, Spain

  • Ascendis Investigational Site

    Barcelona, 08035, Spain

  • Ascendis Investigational Site

    Barcelona, 08908, Spain

  • Ascendis Investigational Site

    Madrid, 28027, Spain

  • Ascendis Investigational Site

    Madrid, 28040, Spain

  • Ascendis Investigational Site

    Madrid, 28041, Spain

  • Ascendis Investigational Site

    Madrid, 28050, Spain

  • Ascendis Investigational Site

    Málaga, 29010, Spain

  • Ascendis Investigational Site

    Murcia, 30120, Spain

  • Ascendis Investigational Site

    Pamplona, 31008, Spain

  • Ascendis Investigational Site

    Seville, 41009, Spain

  • Ascendis Investigational Site

    Valencia, 46009, Spain

  • Ascendis Investigational Site

    Taichung, 404, Taiwan

  • Ascendis Investigational Site

    Taichung, 40705, Taiwan

  • Ascendis Investigational Site

    Tainan, 704, Taiwan

  • Ascendis Investigational Site

    Taipei, 112, Taiwan

  • Ascendis Pharma Investigational Site

    Duarte, California, 91010, United States

  • Ascendis Pharma Investigational Site

    San Francisco, California, 94158, United States

  • Ascendis Pharma Investigational Site

    Chicago, Illinois, 60637, United States

  • Ascendis Pharma Investigational Site

    Iowa City, Iowa, 52242, United States

  • Ascendis Pharma Investigational Site

    Louisville, Kentucky, 40202, United States

  • Ascendis Pharma Investigational Site

    Canton, Ohio, 44718, United States

  • Ascendis Pharma Investigational Site

    Cincinnati, Ohio, 45219, United States

  • Ascendis Pharma Investigational Site

    Cleveland, Ohio, 44106, United States

  • Ascendis Pharma Investigational Site

    Pittsburgh, Pennsylvania, 15232, United States

  • Ascendis Pharma Investigational Site

    Knoxville, Tennessee, 37920, United States

  • Ascendis Pharma Investigational Site

    Fairfax, Virginia, 22031, United States

  • Ascendis Pharma Investigational Site

    Wollongong, New South Wales, 2500, Australia

  • Ascendis Pharma Investigational Site

    Frankston, Victoria, 3199, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.