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New drug combo tested for tough cancers

NCT ID NCT05599984

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase trial tests an investigational drug called ABBV-706, alone or combined with other drugs, in about 288 adults with advanced solid tumors like small cell lung cancer, high-grade brain tumors, and neuroendocrine cancers. The main goals are to check safety, find the right dose, and see if the drug shrinks tumors. Participants will receive the drug through an IV and will be closely monitored with frequent blood tests and scans.

What this could mean

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

Active substance
ABBV-706 (an investigational drug) given alone or with budigalimab, carboplatin, or cisplatin
What this could lead to
If it works, this could point toward a new treatment option for people with advanced small cell lung cancer, high-grade brain tumors, or neuroendocrine cancers.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or could have serious side effects. It is also a small study, so results may not apply to everyone.

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

288 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Nov 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: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * The laboratory values criteria must be met within 7 days prior to the first dose of study drug as per the protocol. * QT interval corrected for heart rate (QTc) \<= 450 msec (males) or \<= 470 msec (females) using Fridericia's correction, and an ejection fraction of \>= 50% as measured by echocardiogram or multigated acquisition (MUGA) scan at Screening. * Part 1 only: Advanced recurrent or refractory solid tumors with potential SEZ6 expression including small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors (glioblastoma \[GBM\], IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4), neuroendocrine prostate cancer (NEPC), high-grade poorly differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC)s, large cell neuroendocrine carcinoma (LCNEC)s, SCLC transformed from epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC), atypical lung carcinoids, and other high-grade poorly differentiated NECs, who have progressed on or after standard of care (SoC) therapy and with no curative therapy available. For SCLC, participants must have histologically or cytologically confirmed SCLC that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy. * Part 2 only: Histologically or cytologically confirmed SCLC that is relapsed or refractory (R/R) following at least 1 prior platinum-containing chemotherapy and with no curative therapy available. For the purposes of this study, a line of therapy is defined as \>= 1 complete cycle of either a single agent or combination of drugs, including any planned sequential therapy of various regimens. * Part 3a only: SCLC or Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed) * Part 3b only: SCLC who have only progressed following a frontline regimen containing a platinum-based chemotherapy (i.e., second-line SCLC subjects) or Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed)tumors (GBM, IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4) who have progressed on SoC therapy and with no curative therapy options available. * Part 4b only: Grade 3 NETs and poorly differentiated NECs. Specific tumor types include but not limited to NEPC, GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, MTC, and other NECs (atypical lung carcinoids that have received prior chemotherapy are allowed) * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for participants with extracranial solid tumors or Response Assessment for Neuro-Oncology (RANO)for participants with primary high-grade CNS tumors (GBM, IDH-wildtype Grade 4; oligodendroglioma, IDH-mutant, and 1p/19q-codeleted Grade 3; astrocytoma, IDH-mutant Grade 3 or Grade 4). * Primary CNS tumors within 12 weeks from radiation therapy should have unequivocal progression as documented by either tumor recurrence predominantly outside of radiation field on magnetic resonance imaging (MRI) or confirmed on tumor biopsy. * Participants with brain metastases from an extracranial solid tumor are eligible if the brain metastases as outlined in the protocol. * Fresh or archival tumor tissue available for submission, for retrospective SEZ6 expression analysis as outlined in the protocol. Exclusion Criteria: * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis. * History of idiopathic pulmonary fibrosis or organizing pneumonia. * Prior treatment with an antibody drug conjugate that consists of a Top1 inhibitor payload. * Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.

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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

  • Austin Health and Ludwig Institute for Cancer Research /ID# 255174

    Heidelberg, Victoria, 3084, Australia

  • Banner MD Anderson Cancer Ctr /ID# 260129

    Gilbert, Arizona, 85234, United States

  • Barbara Ann Karmanos Cancer In /ID# 261799

    Detroit, Michigan, 48201, United States

  • CHA Bundang Medical Center /ID# 248939

    Seongnam, Gyeonggido, 13496, South Korea

  • Cancer Hospital - Chinese Academy Of Medical Sciences /ID# 270044

    Beijing, Beijing Municipality, 100021, China

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413

    Berlin, 12203, Germany

  • Chonnam National University Hwasun Hospital /ID# 248943

    Hwasun-gun, Jeonranamdo, 58128, South Korea

  • Chris O'Brien Lifehouse /ID# 259087

    Camperdown, New South Wales, 2050, Australia

  • City Of Hope Comprehensive Cancer Center /ID# 271295

    Duarte, California, 91030, United States

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884

    Irvine, California, 92618, United States

  • Duke Cancer Center /ID# 246285

    Durham, North Carolina, 27710, United States

  • First Affiliated Hospital of China Medical University /ID# 270041

    Shenyang, Liaoning, 110001, China

  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 258228

    Monza, Monza E Brianza, 20052, Italy

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 260130

    Fort Wayne, Indiana, 46804, United States

  • Georgetown University Hospital /ID# 255352

    Washington D.C., District of Columbia, 20007, United States

  • Hadassah Medical Center-Hebrew University /ID# 255147

    Jerusalem, 91120, Israel

  • Henry Ford Hospital /ID# 246648

    Detroit, Michigan, 48202, United States

  • Hokkaido Cancer Center /ID# 261278

    Sapporo, Hokkaido, 003-0804, Japan

  • Hospital Clinico Universitario de Valencia /ID# 257290

    Valencia, 46010, Spain

  • Hospital HM Nou Delfos /ID# 264851

    Barcelona, 08023, Spain

  • Hospital Santa Creu i Sant Pau /ID# 257294

    Barcelona, 08041, Spain

  • Hospital Universitario 12 de Octubre /ID# 258658

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 257295

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 258657

    Madrid, 28050, Spain

  • Hospital Universitario Ramon y Cajal /ID# 257291

    Madrid, 28034, Spain

  • Hospital Universitario Vall de Hebron /ID# 258659

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio /ID# 256940

    Seville, 41013, Spain

  • Institut Bergonie /ID# 258655

    Bordeaux, Gironde, 33000, France

  • Institut Gustave Roussy /ID# 260334

    Villejuif, Val-de-Marne, 94805, France

  • Institut Régional du Cancer Montpellier /ID# 265086

    Montpellier, 34298, France

  • Istituto Europeo Di Oncologia /ID# 256804

    Milan, Milano, 20141, Italy

  • Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412

    Munich, Bavaria, 80336, Germany

  • Kyoto University Hospital /ID# 259419

    Kyoto, Kyoto, 606-8507, Japan

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 246303

    New York, New York, 10065-6007, United States

  • National Cancer Center /ID# 248938

    Goyang-si, Gyeonggido, 10408, South Korea

  • National Cancer Center Hospital /ID# 259418

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 259417

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Hospital Organization Shikoku Cancer Center /ID# 261279

    Matsuyama, Ehime, 791-0280, Japan

  • Northwest Medical Specialties - Tacoma /ID# 262801

    Tacoma, Washington, 98405, United States

  • Peter MacCallum Cancer Ctr /ID# 259197

    Melbourne, Victoria, 3000, Australia

  • Rambam Health Care Campus /ID# 255059

    Haifa, 3109601, Israel

  • START Midwest /ID# 251257

    Grand Rapids, Michigan, 49546-7062, United States

  • Samsung Medical Center /ID# 248936

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 248940

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shanghai Chest Hospital /ID# 270036

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai East Hospital /ID# 268615

    Shanghai, Shanghai Municipality, 200120, China

  • Shanghai Pulmonary Hospital /Id# 270039

    Shanghai, Shanghai Municipality, 200433, China

  • Shizuoka Cancer Center /ID# 261277

    Sunto-gun, Shizuoka, 411-8777, Japan

  • South Texas Accelerated Research Therapeutics /ID# 248946

    San Antonio, Texas, 78229, United States

  • St. Lukes Hosp. of Kansas City /ID# 259958

    Kansas City, Missouri, 64111, United States

  • Tennessee Oncology, PLLC /ID# 246283

    Nashville, Tennessee, 37203, United States

  • The Cancer Institute Hospital Of JFCR /ID# 260132

    Koto-ku, Tokyo, 135-8550, Japan

  • The Chaim Sheba Medical Center /ID# 254915

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Kinghorn Cancer Centre /ID# 260874

    Darlinghurst, New South Wales, 2010, Australia

  • UH Cleveland Medical Center /ID# 246641

    Cleveland, Ohio, 44106, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 270038

    Wuhan, Hubei, 430022, China

  • Univ Oklahoma HSC /ID# 250884

    Oklahoma City, Oklahoma, 73117, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414

    Dresden, Saxony, 01307, Germany

  • University of Chicago Medical Center /ID# 256334

    Chicago, Illinois, 60637, United States

  • University of Iowa Hospitals and Clinics /ID# 246638

    Iowa City, Iowa, 52242, United States

  • University of Texas MD Anderson Cancer Center /ID# 246287

    Houston, Texas, 77030, United States

  • University of Utah /ID# 246640

    Salt Lake City, Utah, 84112-5500, United States

  • Wakayama Medical University Hospital /ID# 260131

    Wakayama, Wakayama, 641-8510, Japan

  • Washington University-School of Medicine /ID# 246286

    St Louis, Missouri, 63110, United States

  • Yale New Haven Hospital /ID# 246647

    New Haven, Connecticut, 06510, United States

  • Yonsei University Health System Severance Hospital /ID# 248937

    Seoul, 03722, South Korea

More trials for these conditions

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