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Experimental cocktail aims to reboot immune attack on resistant tumors

NCT ID NCT04879849

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tested an experimental drug called TAK-676 combined with the immunotherapy pembrolizumab after radiation therapy in 34 adults with advanced lung, breast, or head/neck cancers that had stopped responding to checkpoint inhibitors. The main goals were to check safety, side effects, and find the best dose of TAK-676. Participants received radiation first, then the drug combo every three weeks.

What this could mean

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

Active substance
TAK-676 (an experimental drug) combined with pembrolizumab (an immunotherapy) after radiation therapy
What this could lead to
If successful, this could point toward a new treatment option for people with certain advanced cancers that have stopped responding to standard immunotherapy.
What could go wrong
This is a very early, small Phase 1 study focused on safety and dosing, not effectiveness. The combination may cause significant side effects and may not 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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2024

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: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 2. Participants must have at least 2 measurable lesions (i.e. ≥10 mm longest diameter for extranodal lesions, ≥15 mm short axis for lymph nodes), with at least one inside and at least one other outside of the radiation field. The tumor outside the radiation field must be accessible for biopsy, and the participant must consent to tumor biopsy at screening and during treatment. 3. Participants must have pathologically confirmed (cytological diagnosis is adequate) advanced or metastatic NSCLC, TNBC, or SCCHN who have: * Received or been offered all established standard of care (SOC) treatment options for which they are eligible; and * Progressed on CPIs in a prior line of therapy. 4. Adequate bone marrow, renal and hepatic functions. 5. Left ventricular ejection fraction (LVEF) \>50%, as measured by echocardiogram or multiple-gated acquisition (MUGA) scan within 4 weeks before receiving the first dose of study drug. 6. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE, V5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy. Exclusion Criteria: 1. History of any serious cardiac or cerebrovascular conditions in the last 6 months, including uncontrolled congestive heart disease, unstable angina, myocardial infarction, hypertension greater than or equal to (≥) 160/100 millimeter of mercury (mmHg) in spite of optimal therapy, cardiac arrhythmias, pericardial effusion, cardiomyopathy, or symptomatic stroke. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular weight heparin, will be allowed. 2. History of brain metastasis unless: * Clinically stable, (that is, treatment completed ≥4 weeks prior) following prior surgery, whole-brain radiation, or stereotactic radiosurgery, AND * Off corticosteroids. 3. Known history of uncontrolled autoimmune disorders, human immunodeficiency virus (HIV) infection, or other relevant congenital or acquired immunodeficiencies. 4. Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]). 5. Treatment with any investigational products and systemic anticancer drugs (including vascular endothelial growth factor (VEGF) inhibitors), within 14 days or 5 half-lives, whichever is shorter, before Cycle 1 Day 1 (C1D1) of study drugs. 6. Prior radiation to lesions chosen for biopsy or response assessment. 7. Prior radiation to lesions other than those chosen for radiation therapy or biopsy in the current protocol within 4 weeks of C1D1 of study drug(s). 8. Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of start of radiation therapy, with the following exceptions: * Topical, intranasal, inhaled, ocular, intra-articular, and/or other nonsystemic corticosteroids. * Physiological doses of replacement steroid therapy (example, for adrenal insufficiency). 9. Receipt of live attenuated vaccine (example, tuberculosis Bacillus Calmette-guerin \[BCG\] vaccine, oral polio vaccine, measles, rotavirus, yellow fiver) within 28 days of C1D1 of study drug(s). 10. Recipients of allogeneic or autologous stem cell transplantation or organ transplantation. 11. Ongoing Grade ≥2 infection or participants with Grade ≥2 fever of malignant origin. 12. Fridericia's corrected QT interval (QTcF) \>450 milliseconds (msec) (males) or \>475 msec (females) on a 12-lead electrocardiogram (ECG) during the screening period. 13. Grade ≥2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 pre-dose assessment. 14. Oxygen saturation less than (\<) 92% on room air at screening or during C1D1 predose assessment. 15. Use of medications that are known clinical organic anion transporting polypeptide 1B1 (OATP1B1) and/or OATP1B3 inhibitors, concurrently or within 14 days of C1D1 of study drugs. 16. Current smoker. 17. Vaping within 90 days of C1D1 of study drugs. 18. Current diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade ≥2 pleural effusion or ascites not controlled by tap or requiring indwelling catheters. 19. Treated with other stimulator of interferon genes (STING) agonists/antagonist and toll-like receptors agonists within the past 6 months.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    Duarte, California, 91010-3012, United States

  • Laura And Isaac Perlmutter Cancer Center

    New York, New York, 10016-4744, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213-2933, United States

  • University of Chicago

    Chicago, Illinois, 60637-1443, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-0021, United States

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