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Advanced Solid TumorsPhase 1NCT05599984

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

A Phase 1 study testing ABBV-706, Cisplatin and Budigalimab in people with Advanced Solid Tumors, run by AbbVie at 66 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ABBV-706, Cisplatin and Budigalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
66 sitesin 10 countries
Study dates
5 Dec 2022to Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

66 sites in 10 countries.

66 sites in 10 countries

United States22 sites

  • University of Chicago Medical Center /ID# 256334

    Chicago, Illinois, 60637

  • UH Cleveland Medical Center /ID# 246641

    Cleveland, Ohio, 44106

  • Barbara Ann Karmanos Cancer In /ID# 261799

    Detroit, Michigan, 48201

  • Henry Ford Hospital /ID# 246648

    Detroit, Michigan, 48202

  • City Of Hope Comprehensive Cancer Center /ID# 271295

    Duarte, California, 91030

  • Duke Cancer Center /ID# 246285

    Durham, North Carolina, 27710

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

    Fort Wayne, Indiana, 46804

  • Banner MD Anderson Cancer Ctr /ID# 260129

    Gilbert, Arizona, 85234

  • START Midwest /ID# 251257

    Grand Rapids, Michigan, 49546-7062

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

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics /ID# 246638

    Iowa City, Iowa, 52242

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

    Irvine, California, 92618

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

    Kansas City, Missouri, 64111

  • Tennessee Oncology, PLLC /ID# 246283

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital /ID# 246647

    New Haven, Connecticut, 06510

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

    New York, New York, 10065-6007

  • Univ Oklahoma HSC /ID# 250884

    Oklahoma City, Oklahoma, 73117

  • University of Utah /ID# 246640

    Salt Lake City, Utah, 84112-5500

  • South Texas Accelerated Research Therapeutics /ID# 248946

    San Antonio, Texas, 78229

  • Washington University-School of Medicine /ID# 246286

    St Louis, Missouri, 63110

  • Northwest Medical Specialties - Tacoma /ID# 262801

    Tacoma, Washington, 98405

  • Georgetown University Hospital /ID# 255352

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain9 sites

  • Hospital HM Nou Delfos /ID# 264851

    Barcelona, 08023

  • Hospital Universitario Vall de Hebron /ID# 258659

    Barcelona, 08035

  • Hospital Santa Creu i Sant Pau /ID# 257294

    Barcelona, 08041

  • Hospital Universitario Ramon y Cajal /ID# 257291

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 257295

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 258658

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro /ID# 258657

    Madrid, 28050

  • Hospital Universitario Virgen del Rocio /ID# 256940

    Seville, 41013

  • Hospital Clinico Universitario de Valencia /ID# 257290

    Valencia, 46010

Other trials in Spain

Japan8 sites

  • National Cancer Center Hospital /ID# 259418

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 259417

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital Of JFCR /ID# 260132

    Koto-ku, Tokyo, 135-8550

  • Kyoto University Hospital /ID# 259419

    Kyoto, Kyoto, 606-8507

  • National Hospital Organization Shikoku Cancer Center /ID# 261279

    Matsuyama, Ehime, 791-0280

  • Hokkaido Cancer Center /ID# 261278

    Sapporo, Hokkaido, 003-0804

  • Shizuoka Cancer Center /ID# 261277

    Sunto-gun, Shizuoka, 411-8777

  • Wakayama Medical University Hospital /ID# 260131

    Wakayama, Wakayama, 641-8510

Other trials in Japan

China6 sites

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

    Beijing, Beijing Municipality, 100021

  • Shanghai Chest Hospital /ID# 270036

    Shanghai, Shanghai Municipality, 200030

  • Shanghai East Hospital /ID# 268615

    Shanghai, Shanghai Municipality, 200120

  • Shanghai Pulmonary Hospital /Id# 270039

    Shanghai, Shanghai Municipality, 200433

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

    Shenyang, Liaoning, 110001

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

    Wuhan, Hubei, 430022

Other trials in China

South Korea6 sites

  • National Cancer Center /ID# 248938

    Goyang-si, Gyeonggido, 10408

  • Chonnam National University Hwasun Hospital /ID# 248943

    Hwasun-gun, Jeonranamdo, 58128

  • CHA Bundang Medical Center /ID# 248939

    Seongnam, Gyeonggido, 13496

  • Seoul National University Hospital /ID# 248940

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 248936

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 248937

    Seoul, 03722

Other trials in South Korea

Australia4 sites

  • Chris O'Brien Lifehouse /ID# 259087

    Camperdown, New South Wales, 2050

  • The Kinghorn Cancer Centre /ID# 260874

    Darlinghurst, New South Wales, 2010

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

    Heidelberg, Victoria, 3084

  • Peter MacCallum Cancer Ctr /ID# 259197

    Melbourne, Victoria, 3000

Other trials in Australia

France3 sites

  • Institut Bergonie /ID# 258655

    Bordeaux, Gironde, 33000

  • Institut Régional du Cancer Montpellier /ID# 265086

    Montpellier, 34298

  • Institut Gustave Roussy /ID# 260334

    Villejuif, Val-de-Marne, 94805

Other trials in France

Germany3 sites

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

    Berlin, 12203

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414

    Dresden, Saxony, 01307

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

    Munich, Bavaria, 80336

Other trials in Germany

Israel3 sites

  • Rambam Health Care Campus /ID# 255059

    Haifa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 255147

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 254915

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Italy2 sites

  • Istituto Europeo Di Oncologia /ID# 256804

    Milan, Milano, 20141

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

    Monza, Monza E Brianza, 20052

Other trials in Italy

About this study

Official title: A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin.

ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide.

Read more

In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Being tested
ABBV-706, Cisplatin, Budigalimab, Carboplatin
Keywords
Advanced Solid Tumors, Small Cell Lung Cancer, Central Nervous System Tumors, ABBV-706, ABBV-181, Budigalimab, Platinum Chemotherapy Combination, Carboplatin, Cisplatin, Neuroendocrine Carcinomas, Cancer
Medical subject headings
Small Cell Lung Carcinoma, Central Nervous System Neoplasms, Carcinoma, Neuroendocrine, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-706Drug

    Intravenous (IV) Infusion

  • CisplatinDrug

    Intravenous infusion

  • BudigalimabDrug

    Also called ABBV-181

    IV Infusion

  • CarboplatinDrug

    Intravenous infusion

Study groups in NCT05599984
Study groupRoleWhat they receive
Part 1: ABBV-706 Monotherapy Dose EscalationExperimentalParticipants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 2 year treatment period.
Receives: Drug: ABBV-706
Part 2: ABBV-706 Monotherapy Dose Optimization and ExpansionExperimentalParticipants with small cell lung cancer will receive varying doses of ABBV-706 in a randomized manner until the recommended phase 2 dose (RP2D) is achieved, as part of an approximately 2 year treatment period..
Receives: Drug: ABBV-706
Part 3a: ABBV-706 + BudigalimabExperimentalParticipants will receive ABBV-706 in combination with budigalimab, as part of an approximately 2 year treatment period.
Receives: Drug: ABBV-706; Drug: Budigalimab
Part 3b: ABBV-706 + Platinum ChemotherapyExperimentalParticipants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 2 year treatment period.
Receives: Drug: ABBV-706; Drug: Cisplatin; Drug: Carboplatin
Part 4a: ABBV-706 Monotherapy Dose Expansion CNS TumorsExperimentalParticipants with relapsed/refractory (R/R) central nervous system (CNS) tumors will receive ABBV-706 as a monotherapy at or below the maximum tolerated dose (MTD) maximum administered dose (MAD), as part of an approximately 2 year treatment period.
Receives: Drug: ABBV-706
Part 4b: ABBV-706 Monotherapy Dose Expansion NECsExperimentalParticipants with R/R neuroendocrine carcinomas (NECs) will receive IV Infused ABBV-706 as a monotherapy at or below the MTD/MAD, as part of an approximately 2 year treatment period.
Receives: Drug: ABBV-706

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AE)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately 2 Years

  2. Maximum Observed Serum/Plasma Concentration (Cmax) of ABBV-706

    Maximum observed serum/plasma concentration of ABBV-706.

    Measured: Up to Approximately 2 Years

  3. Time to Cmax (Tmax) of ABBV-706

    Time to Cmax of ABBV-706.

    Measured: Up to Approximately 2 Years

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-706

    Terminal phase elimination half-life (t1/2) of ABBV-706.

    Measured: Up to Approximately 2 Years

  5. Area Under the Serum/Plasma Concentration-Time Curve (AUC) of ABBV-706

    Area under the serum/plasma concentration-time curve of ABBV-706.

    Measured: Up to Approximately 2 Years

  6. Antidrug Antibodies (ADAs)

    Incidence and concentration of anti-drug antibodies.

    Measured: Up to Approximately 2 Years

  7. Neutralizing Antibodies (nAbs)

    Incidence and concentration of neutralizing antibodies.

    Measured: Up to Approximately 2 Years

  8. Percentage of Participants with Objective Response, for Participants with Extracranial Solid Tumors

    Objective response is defined as participants achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 for for extracranial solid tumors per investigator assessment.

    Measured: Up to Approximately 2 Years

  9. Recommended Phase 2 Dose (RP2D) of ABBV-706

    The RP2D will be determined using all available information, including, but not limited to, AEs, dose-limiting toxicities, pharmacokinetic parameters, clinical laboratory tests, and efficacy measures.

    Measured: Up to Approximately 2 Years

  10. Percentage of Participants with Objective Response for Participants with Central Nervous System (CNS) Tumors

    Objective response is as participants achieving a confirmed best overall response of CR and PR according to Response Assessment for Neuro-Oncology (RANO), version 1.1 for CNS tumors per investigator assessment.

    Measured: Up to Approximately 2 Years

  11. Duration of response (DOR) for Participants with Confirmed CR/PR

    For participants achieving a confirmed CR/PR, DOR is defined as the time from the initial response of CR/PR to disease progression or death of any cause, whichever occurs earlier.

    Measured: Up to Approximately 2 Years

  12. Percentage of Participants with Clinical Benefit

    Clinical benefit is defined as a participant achieving CR/PR, or Stable Disease (SD).

    Measured: Up to Approximately 2 Years

  13. Progression-Free Survival (PFS)

    PFS is defined as time from first study treatment to a documented disease progression, as determined by the investigator, or death due to any cause, whichever occurs earlier.

    Measured: Up to Approximately 2 Years

  14. Overall survival (OS)

    OS is defined as time from first study treatment to death due to any cause.

    Measured: Up to Approximately 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start5 Dec 2022
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599984
Sponsor's protocol ID
M23-385
Other IDs
2023-504598-18-00, 2023
Status last verified
May 2026
First submitted
28 Oct 2022
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Byers LA, Cho BC, Cooper AJ, Chiang AC, Han JY, Furqan M, Dowlati A, Morgensztern D, Papadopoulos KP, Choudhury NJ, Vieito M, Bar J, Kim JH, Akerley W, Kim TM, Kim YC, Paz-Ares L, Ahn MJ, Yokouchi H, Meiman D, Munasinghe W, Ogunyankin O, Jahchan N, Wang S, Ferlini C, Robinson RR, Kohlhapp FJ, Palenski T, Rivell G, Hingorani P, Chandana S. SEZ6-targeting antibody-drug conjugate ABBV-706 in advanced small cell lung cancer and solid tumors: a phase 1 trial. Nat Med. 2026 Aug;32(8):2898-2908. doi: 10.1038/s41591-026-04452-0. Epub 2026 Jun 1.

    PubMed 42225988

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-706, Cisplatin and Budigalimab in people with Advanced Solid Tumors, run by AbbVie at 66 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Spain, Japan, China, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AE) (time frame: Up to Approximately 2 Years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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Clinical Trial NCT05599984 | AzTrials