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New antibody combo aims to supercharge immune system against Hard-to-Treat cancers

NCT ID NCT04198766

Disease control Sponsor: Inhibrx Biosciences, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 3 times

Summary

This early-phase trial is testing an experimental drug called INBRX-106, alone or combined with the immunotherapy Keytruda, in people with advanced solid tumors (including lung, head and neck, melanoma, and others) that have stopped responding to standard treatments. The main goals are to check safety, find the best dose, and see if the combination can shrink tumors. About 296 adults are taking part across multiple sites.

What this could mean

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

Active substance
INBRX-106 (an experimental antibody that targets OX40 receptors on immune cells) and pembrolizumab (Keytruda, 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 standard therapies.
What could go wrong
This is an early Phase 1/2 trial, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors. Results may not apply to all cancer types.

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

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jul 2033

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.

Select Inclusion Criteria: * Males or females aged ≥18 years. * Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists. * Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G/GEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists. * Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists. * For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1/L1 regimen. * For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1/L1 in curative (neo-adjuvant/adjuvant) setting is allowed only if completed \>/= 6 months prior to progression to local recurrence or metastatic disease. * For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery. * All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements. * PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable. * Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol. Select Exclusion Criteria: * Prior exposure to OX40 agonists. Exposure to anti-PD-1 and/or anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways. * Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions. * Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma) * Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106. * Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply. * Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply. * Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply. * History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply. * Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications. * Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \< 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \< 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \<92% on room air. * Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial. * Major surgery within 4 weeks prior to enrollment on this trial. * Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug. * Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation. * Additional in- and exclusion criteria per protocol.

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Conditions

The condition(s) this trial relates to.

carcinoma epithelial neoplasm gastric cancer gastric neoplasm head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma hypopharynx cancer lung neoplasm melanoma Mouth Neoplasms nasopharyngeal carcinoma neoplasm Neoplasms by Histologic Type Neoplasms by Site non-small cell lung carcinoma oropharynx cancer renal cell carcinoma squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck squamous cell neoplasm transitional cell carcinoma urothelial carcinoma uveal melanoma

As listed by the trial registrant

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

Gastric cancer Head and neck cancer Melanoma Non-small cell lung cancer Renal cell carcinoma Resectable non-small cell lung cancer Solid tumor Urothelial carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, South Korea

  • Barbara Ann Karmanos Cancer Institute

    COMPLETED

    Detroit, Michigan, 48201, United States

  • California Research Institute

    RECRUITING

    Los Angeles, California, 90027, United States

  • Changhua Christian Hospital (CCH)

    ACTIVE_NOT_RECRUITING

    Changhua, Taiwan

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Clermont Oncology Center

    RECRUITING

    Clermont, Florida, 34711, United States

  • Cleveland Clinic

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Curie Oncology

    COMPLETED

    Singapore, Singapore

  • E-Da Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Kaohsiung City, Taiwan

  • Froedtert Hospital and the Medical College of Wisconsin

    ACTIVE_NOT_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • HealthPartners Cancer Research Center

    ACTIVE_NOT_RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • HealthPartners Cancer Research Center (Regions Hospital)

    COMPLETED

    Saint Paul, Minnesota, 55101, United States

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Icon Cancer Centre Farrer Park

    COMPLETED

    Singapore, Singapore

  • Icon Cancer Centre Mount Alvernia

    COMPLETED

    Singapore, Singapore

  • Intermountain Health Cancer Centers of Montana

    COMPLETED

    Billings, Montana, 59102, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    ACTIVE_NOT_RECRUITING

    Kaohsiung City, Taiwan

  • Los Angeles Cancer Network

    RECRUITING

    Glendale, California, 91204, United States

  • Mid Florida Hematology and Oncology Center

    RECRUITING

    Orange City, Florida, 32763, United States

  • Montefiore Medical Center

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10467, United States

  • NEXT Oncology

    COMPLETED

    San Antonio, Texas, 78229, United States

  • National Cheng Kung University Hospital

    ACTIVE_NOT_RECRUITING

    Tainan, Taiwan

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Providence Medical Foundation

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Providence Portland Medical Center

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97213, United States

  • Renovatio Clinical

    COMPLETED

    The Woodlands, Texas, 77380, United States

  • Renovatio Clinical - El Paso

    COMPLETED

    El Paso, Texas, 79915, United States

  • START Midwest

    ACTIVE_NOT_RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Sarah Cannon Research Institute at Mary Crowley

    COMPLETED

    Dallas, Texas, 75230, United States

  • Severance Hospital, Yonsei University Health System

    ACTIVE_NOT_RECRUITING

    Seoul, South Korea

  • Taipei Veterans General Hospital

    COMPLETED

    Taipei, Taiwan

  • The Catholic University of Korea Seoul St. Mary's Hospital,

    ACTIVE_NOT_RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    ACTIVE_NOT_RECRUITING

    Gyeonggi-do, South Korea

  • The University of Chicago Medical Center

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60637, United States

  • The University of Texas Health Science Center at Tyler

    RECRUITING

    Tyler, Texas, 75701, United States

  • University of Iowa

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52242, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90069, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Murrieta, California, 92562, United States

  • Vanderbilt University School of Medicine

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37204, United States

  • Virginia Cancer Specialists

    COMPLETED

    Fairfax, Virginia, 22031, United States

  • Winship Cancer Institute - Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

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