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

Last updated: March 24, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Cisplatin

Carboplatin

ABBV-706

Clinical Study ID

NCT05599984
M23-385
  • Ages > 18
  • All Genders

Study 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.

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 350 adult participants will be enrolled in the study across sites worldwide.

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 3 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.

Eligibility Criteria

Inclusion

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 ofstudy 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% asmeasured by echocardiogram or multigated acquisition (MUGA) scan at Screening.

  • Part 1 only: Advanced recurrent or refractory solid tumors with potential SEZ6expression including small cell lung cancer (SCLC), high-grade central nervoussystem (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 differentiatedgastroenteropancreatic neuroendocrine carcinoma (GEP-NEC)s, large cellneuroendocrine carcinoma (LCNEC)s, SCLC transformed from epidermal growth factorreceptor (EGFR) mutant non-small cell lung cancer (NSCLC), atypical lung carcinoids,and other high-grade poorly differentiated NECs, who have progressed on or afterstandard of care (SoC) therapy and with no curative therapy available. For SCLC,participants must have histologically or cytologically confirmed SCLC that isrelapsed or refractory following at least 1 prior platinum-containing chemotherapy.

  • Part 2 only: Histologically or cytologically confirmed SCLC that is relapsed orrefractory (R/R) following at least 1 prior platinum-containing chemotherapy andwith no curative therapy available. For the purposes of this study, a line oftherapy is defined as >= 1 complete cycle of either a single agent or combination ofdrugs, including any planned sequential therapy of various regimens.

  • Part 3a only: Participants with R/R SCLC following at least 1 priorplatinum-containing chemotherapy or R/R poorly differentiated NECs, e.g., NEPC,GEP-NECs, LCNECs, SCLC transformed from EGFR mutant Non-small cell lung cancer (NSCLC), atypical lung carcinoids, other high-grade poorly differentiated NECs.

  • Part 3b only: Participants with R/R SCLC who have only progressed following afrontline regimen containing a platinum-based chemotherapy or R/R NECs, e.g., NEPC,GEP-NECs, LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids,other NECs.

  • Part 4a only: Participants with R/R 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) who have progressed on SoC therapy and with nocurative therapy options available.

  • Part 4b only: Participants with R/R neuroendocrine tumors, including NEPC, GEP-NECs,LCNECs, SCLC transformed from EGFR mutant NSCLC, atypical lung carcinoids, and otherhigh-grade poorly differentiated NECs, who have progressed on SoC therapy and withno curative therapy options available.

  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for participants with extracranial solid tumors or Response Assessment forNeuro-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 unequivocalprogression as documented by either tumor recurrence predominantly outside ofradiation field on magnetic resonance imaging (MRI) or confirmed on tumor biopsy.

  • Participants with brain metastases from an extracranial solid tumor are eligible ifthe brain metastases as outlined in the protocol.

  • Fresh or archival tumor tissue available for submission, for retrospective SEZ6expression analysis as outlined in the protocol.

Exclusion

Exclusion Criteria:

  • History of interstitial lung disease (ILD) or pneumonitis that required treatmentwith 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 inhibitorpayload.

  • Part 2 only: Prior treatment with a SEZ6-targeted antibody drug conjugate.

Study Design

Total Participants: 350
Treatment Group(s): 4
Primary Treatment: Cisplatin
Phase: 1
Study Start date:
December 05, 2022
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Chris O'Brien Lifehouse /ID# 259087

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • The Kinghorn Cancer Centre /ID# 260874

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

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

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Ctr /ID# 259197

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

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

    Beijing, Beijing 100021
    China

    Active - Recruiting

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

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • The first hospital of China medical University /ID# 270041

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • Shanghai East Hospital /ID# 268615

    Shanghai, Shanghai 200120
    China

    Active - Recruiting

  • Institut Bergonie /ID# 258655

    Bordeaux, Gironde 33000
    France

    Active - Recruiting

  • Institut Gustave Roussy /ID# 260334

    Villejuif Cedex, Val-de-Marne 94805
    France

    Active - Recruiting

  • Institut Régional du Cancer Montpellier /ID# 265086

    Montpellier, 34298
    France

    Active - Recruiting

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

    Munich, Bayern 80336
    Germany

    Active - Recruiting

  • Klinikum der Universität München - Campus Innenstadt /ID# 259412

    Munich, Bayern 80336
    Germany

    Active - Recruiting

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

    Berlin, 12203
    Germany

    Active - Recruiting

  • Technische Universitat Dresden /ID# 259414

    Dresden, 01307
    Germany

    Active - Recruiting

  • Rambam Health Care Campus /ID# 255059

    Haifa, H_efa 3109601
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 254915

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Hadassah Medical Center /ID# 255147

    Jerusalem, Yerushalayim 9112001
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 255147

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • IEO -Istituto Europeo di Oncologia /ID# 256804

    Milan, Milano 20141
    Italy

    Active - Recruiting

  • Istituto Europeo Di Oncologia /ID# 256804

    Milan, Milano 20141
    Italy

    Active - Recruiting

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

    Monza, Monza E Brianza 20052
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori /ID# 258228

    Monza, Monza E Brianza 20052
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East /ID# 259417

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center /ID# 261279

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center /ID# 261279

    Matsuyama-shi, Ehime 791-0280
    Japan

    Site Not Available

  • Hokkaido Cancer Center /ID# 261278

    Sapporo-shi, Hokkaido 003-0804
    Japan

    Active - Recruiting

  • Kyoto University Hospital /ID# 259419

    Kyoto-shi, Kyoto 606-8507
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center /ID# 261277

    Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital /ID# 259418

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital Of JFCR /ID# 260132

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital Of JFCR /ID# 260132

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital /ID# 260131

    Wakayama-shi, Wakayama 641-8510
    Japan

    Active - Recruiting

  • National Cancer Center /ID# 248938

    Goyang, Gyeonggido 10408
    Korea, Republic of

    Site Not Available

  • National Cancer Center /ID# 248938

    Goyang-si, Gyeonggido 10408
    Korea, Republic of

    Active - Recruiting

  • CHA Bundang Medical Center /ID# 248939

    Seongnam, Gyeonggido 13496
    Korea, Republic of

    Active - Recruiting

  • CHA University Bundang Medical Center /ID# 248939

    Seongnam si, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center /ID# 248939

    성남시, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital /ID# 248943

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center /ID# 248936

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital /ID# 248940

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital /ID# 248943

    Jeonnam, 58128
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System Severance Hospital /ID# 248937

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Hospital HM Nou Delfos /ID# 264851

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Santa Creu i Sant Pau /ID# 257294

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron /ID# 258659

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre /ID# 258658

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 257295

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro /ID# 258657

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal /ID# 257291

    Madrid, 28034
    Spain

    Active - Recruiting

  • Duplicate_Hospital Universitario Virgen del Rocio /ID# 256940

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio /ID# 256940

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia /ID# 257290

    Valencia, 46010
    Spain

    Active - Recruiting

  • Banner MD Anderson Cancer Ctr /ID# 260129

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • City Of Hope Comprehensive Cancer Center /ID# 271295

    Duarte, California 91030
    United States

    Active - Recruiting

  • City of Hope /ID# 259884

    Duarte, California 91010
    United States

    Active - Recruiting

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

    Irvine, California 92618
    United States

    Active - Recruiting

  • Yale New Haven Hospital /ID# 246647

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale School of Medicine /ID# 246647

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Georgetown University Hospital /ID# 255352

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • University of Chicago /ID# 256334

    Chicago, Illinois 60637
    United States

    Active - Recruiting

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

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics /ID# 246638

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer In /ID# 261799

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Henry Ford Hospital /ID# 246648

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • START Midwest /ID# 251257

    Grand Rapids, Michigan 49546-7062
    United States

    Active - Recruiting

  • St. Luke's Hosp. of Kansas City /ID# 259958

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Washington University-School of Medicine /ID# 246286

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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

    New York, New York 10065-6007
    United States

    Active - Recruiting

  • Duke Cancer Center /ID# 246285

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • UH Cleveland Medical Center /ID# 246641

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center Seidman Cancer Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center Seidman Cancer Center /ID# 246641

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Univ Oklahoma HSC /ID# 250884

    Oklahoma City, Oklahoma 73117
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC /ID# 246283

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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

    Houston, Texas 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics /ID# 248946

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Utah /ID# 246640

    Salt Lake City, Utah 84112-5500
    United States

    Active - Recruiting

  • Northwest Medical Specialties - Tacoma /ID# 262801

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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