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ACTIVE NOT RECRUITING

NCT05599984

PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2022-12-05

Completion Date

2026-06

Last Updated

2025-10-20

Healthy Volunteers

Conditions

Advanced Solid Tumors

Interventions

DRUG

ABBV-706

Intravenous (IV) Infusion

DRUG

Cisplatin

Intravenous infusion

DRUG

Budigalimab

IV Infusion

DRUG

Carboplatin

Intravenous infusion

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: Participants with R/R SCLC following at least 1 prior platinum-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 a frontline 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 no curative 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 other high-grade poorly differentiated NECs, who have progressed on SoC therapy and with no 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 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.

Locations (66)

Banner MD Anderson Cancer Ctr /ID# 260129

Gilbert, Arizona, United States

City Of Hope Comprehensive Cancer Center /ID# 271295

Duarte, California, United States

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

Irvine, California, United States

Yale New Haven Hospital /ID# 246647

New Haven, Connecticut, United States

Georgetown University Hospital /ID# 255352

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

University of Chicago Medical Center /ID# 256334

Chicago, Illinois, United States

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

Fort Wayne, Indiana, United States

University of Iowa Hospitals and Clinics /ID# 246638

Iowa City, Iowa, United States

Barbara Ann Karmanos Cancer In /ID# 261799

Detroit, Michigan, United States

Henry Ford Hospital /ID# 246648

Detroit, Michigan, United States

START Midwest /ID# 251257

Grand Rapids, Michigan, United States

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

Kansas City, Missouri, United States

Washington University-School of Medicine /ID# 246286

St Louis, Missouri, United States

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

New York, New York, United States

Duke Cancer Center /ID# 246285

Durham, North Carolina, United States

UH Cleveland Medical Center /ID# 246641

Cleveland, Ohio, United States

Univ Oklahoma HSC /ID# 250884

Oklahoma City, Oklahoma, United States

Tennessee Oncology, PLLC /ID# 246283

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center /ID# 246287

Houston, Texas, United States

South Texas Accelerated Research Therapeutics /ID# 248946

San Antonio, Texas, United States

University of Utah /ID# 246640

Salt Lake City, Utah, United States

Northwest Medical Specialties - Tacoma /ID# 262801

Tacoma, Washington, United States

Chris O'Brien Lifehouse /ID# 259087

Camperdown, New South Wales, Australia

The Kinghorn Cancer Centre /ID# 260874

Darlinghurst, New South Wales, Australia

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

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Ctr /ID# 259197

Melbourne, Victoria, Australia

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

Beijing, Beijing Municipality, China

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

Wuhan, Hubei, China

First Affiliated Hospital of China Medical University /ID# 270041

Shenyang, Liaoning, China

Shanghai Chest Hospital /ID# 270036

Shanghai, Shanghai Municipality, China

Shanghai East Hospital /ID# 268615

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital /Id# 270039

Shanghai, Shanghai Municipality, China

Institut Bergonie /ID# 258655

Bordeaux, Gironde, France

Institut Gustave Roussy /ID# 260334

Villejuif, Val-de-Marne, France

Institut Régional du Cancer Montpellier /ID# 265086

Montpellier, France

Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412

Munich, Bavaria, Germany

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414

Dresden, Saxony, Germany

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413

Berlin, Germany

The Chaim Sheba Medical Center /ID# 254915

Ramat Gan, Tel Aviv, Israel

Rambam Health Care Campus /ID# 255059

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 255147

Jerusalem, Israel

Istituto Europeo Di Oncologia /ID# 256804

Milan, Milano, Italy

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

Monza, Monza E Brianza, Italy

National Cancer Center Hospital East /ID# 259417

Kashiwa-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center /ID# 261279

Matsuyama, Ehime, Japan

Hokkaido Cancer Center /ID# 261278

Sapporo, Hokkaido, Japan

Kyoto University Hospital /ID# 259419

Kyoto, Kyoto, Japan

Shizuoka Cancer Center /ID# 261277

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital /ID# 259418

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 260132

Koto-ku, Tokyo, Japan

Wakayama Medical University Hospital /ID# 260131

Wakayama, Wakayama, Japan

National Cancer Center /ID# 248938

Goyang-si, Gyeonggido, South Korea

CHA Bundang Medical Center /ID# 248939

Seongnam, Gyeonggido, South Korea

Chonnam National University Hwasun Hospital /ID# 248943

Hwasun-gun, Jeonranamdo, South Korea

Seoul National University Hospital /ID# 248940

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 248936

Seoul, Seoul Teugbyeolsi, South Korea

Yonsei University Health System Severance Hospital /ID# 248937

Seoul, South Korea

Hospital HM Nou Delfos /ID# 264851

Barcelona, Spain

Hospital Universitario Vall de Hebron /ID# 258659

Barcelona, Spain

Hospital Santa Creu i Sant Pau /ID# 257294

Barcelona, Spain

Hospital Universitario Ramon y Cajal /ID# 257291

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 257295

Madrid, Spain

Hospital Universitario 12 de Octubre /ID# 258658

Madrid, Spain

Hospital Universitario HM Sanchinarro /ID# 258657

Madrid, Spain

Hospital Universitario Virgen del Rocio /ID# 256940

Seville, Spain

Hospital Clinico Universitario de Valencia /ID# 257290

Valencia, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (66)