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New cancer drug combo enters human testing

NCT ID NCT05007782

Disease control Sponsor: Gilead Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 3 times

Summary

This early-stage trial tests a new drug called denikitug, alone or with another drug (zimberelimab), in 416 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see if the drugs shrink tumors. It is a first-in-human study, so results are very preliminary.

What this could mean

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

Active substance
Denikitug (GS-1811) and zimberelimab
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early phase 1 trial focused on safety and dosing, not yet on effectiveness. Many experimental cancer drugs fail in early testing, and side effects are unknown.

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

304 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Dec 2028

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: * Disease: * Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit. * Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit. * Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-\[L\]1) monoclonal antibody monotherapy. * Part D: Individuals with pathologically confirmed select advanced solid tumors. * Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatment known to confer clinical benefit. * Part F: Individuals with pathologically-confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit; or, for participants who will undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D, E, and F. * Adequate organ function. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception. * Tissue requirement: * Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment. * Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis. Key Exclusion Criteria: * Concurrent anticancer treatment. * Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\< 14 days), hormonal therapy or other adjunctive therapy (\< 14 days) or radiotherapy (\< 21 days). * Any prior CCR8 directed therapy. * Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed. * Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for \> 2 years. * History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy. * History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years. * History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis). * Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics. * Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV). * Positive serum pregnancy test or breastfeeding female. * Live vaccines within 30 days prior to first dose. * Significant cardiovascular disease. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33308, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, 73657, Taiwan

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Hospital Universitari Vall d´Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223, Spain

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • National Taiwan University Cancer Center (NTUCC)

    Taipei, 100229, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Sarah Cannon Research Institute at Mary Crowley

    Dallas, Texas, 75230, United States

  • Smilow Cancer Center

    New Haven, Connecticut, 06510, United States

  • Stanford Cancer Center

    Palo Alto, California, 94305, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, M5G 2M9, Canada

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 39090, United States

  • University of Wisconsin Clinical Sciences Center

    Madison, Wisconsin, 53705, United States

More trials for these conditions

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