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New hope for Hard-to-Treat cancers: first human trial launches

NCT ID NCT05005403

Disease control Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called azirkitug, alone or with other cancer medicines, in people with advanced solid tumors like lung, head/neck, and pancreatic cancers. The goal is to find safe doses and check side effects. About 694 adults will take part worldwide, receiving treatment for up to 2 years.

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

About 694 people

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

Started

Nov 2021

Expected to finish

Jul 2027

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.

Inclusion Criteria: * Pre Treatment biopsy or archive tissue within 6 months without intervening treatment * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 0 or 1 and a life expectancy of \>= 3 months. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) * Laboratory values meeting criteria outlined in the protocol * NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options. * HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting. * Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient * Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and/or HER2 therapy * High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have \>5 lines of prior therapy. * Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple. * Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation Exclusion Criteria: * Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE * No major surgery within 28 days prior to dosing * No active autoimmune/immunodeficiency disease with limited exceptions * Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events * Pregnancy * Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions

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Conditions

The condition(s) this trial relates to.

colorectal cancer Esophageal Neoplasms gastric adenocarcinoma gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma malignant pancreatic neoplasm Matthew-Wood syndrome non-small cell lung carcinoma ovarian serous adenocarcinoma pancreatic adenocarcinoma pancreatic neoplasm Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

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

Gastric/esophageal cancer Head and neck squamous cell carcinoma High grade serous ovarian cancer Micro satellite stable colorectal cancer Non-small cell lung cancer Pancreatic cancer Triple-negative breast cancer

How to take part

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

  1. The places running it

    47 sites in 6 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Aichi Cancer Center Hospital /ID# 250405

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center /ID# 252289

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • CHA Bundang Medical Center /ID# 252291

    RECRUITING

    Seongnam, Gyeonggido, 13496, South Korea

  • Carolina BioOncology Institute /ID# 232597

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope National Medical Center /ID# 276272

    RECRUITING

    Duarte, California, 91010, United States

  • Community Health Network, Inc. /ID# 243011

    RECRUITING

    Indianapolis, Indiana, 46250-2042, United States

  • Duke Cancer Institute /ID# 276267

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Hadassah Medical Center-Hebrew University /ID# 252287

    RECRUITING

    Jerusalem, 91120, Israel

  • Kansai Medical University Hospital /ID# 276805

    RECRUITING

    Hirakata-shi, Osaka, 573-1191, Japan

  • Kobe University Hospital /ID# 250409

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Meir Medical Center /ID# 277327

    RECRUITING

    Kefar Sava, Central District, 4428164, Israel

  • NEXT Oncology /ID# 243007

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Oncology Austin /ID# 243005

    RECRUITING

    Austin, Texas, 78705-1171, United States

  • National Cancer Center /ID# 252290

    RECRUITING

    Goyang-si, Gyeonggido, 10408, South Korea

  • National Cancer Center Hospital /ID# 238372

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 238840

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 252262

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 251894

    RECRUITING

    Taipei, 100, Taiwan

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Next Oncology Dallas /ID# 276254

    RECRUITING

    Irving, Texas, 75039, United States

  • Norton Cancer Institute /ID# 248903

    RECRUITING

    Louisville, Kentucky, 40241-2832, United States

  • Princess Margaret Cancer Centre /ID# 276275

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center. /ID# 250497

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus /ID# 238333

    RECRUITING

    Haifa, 3109601, Israel

  • START Midwest /ID# 248685

    RECRUITING

    Grand Rapids, Michigan, 49546-7062, United States

  • Shaare Zedek Medical Center /ID# 276244

    RECRUITING

    Jerusalem, 9103102, Israel

  • Shamir Medical Center /ID# 276238

    RECRUITING

    Beer Ya'akov, Central District, 70300, Israel

  • Shizuoka Cancer Center /ID# 250408

    RECRUITING

    Sunto-gun, Shizuoka, 411-8777, Japan

  • South Texas Accelerated Research Therapeutics (START) /ID# 276268

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Start Mountain Region /ID# 276270

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Taipei Medical University Hospital /ID# 252450

    RECRUITING

    Taipei, 11031, Taiwan

  • Taipei Medical University Shuang Ho Hospital /ID# 252449

    RECRUITING

    New Taipei City, 23561, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 276591

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • The Chaim Sheba Medical Center /ID# 238332

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The University of Texas MD Anderson Cancer Center /ID# 270059

    RECRUITING

    Houston, Texas, 77030, United States

  • Tom Baker Cancer Centre /ID# 276206

    RECRUITING

    Calgary, Alberta, T2N 4N2, Canada

  • Tri-Service General Hospital /ID# 252263

    RECRUITING

    Taipei, 11490, Taiwan

  • USC Norris Comprehensive Cancer Center /ID# 279603

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Chicago Medical Center /ID# 276271

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Illinois Hospital and Health Sciences System /ID# 251750

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Virginia Cancer Specialists - Fairfax /ID# 232592

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital /ID# 276806

    COMPLETED

    Wakayama, Wakayama, 641-8510, Japan

  • Yonsei University Health System Severance Hospital /ID# 252288

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

More trials for these conditions

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