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

NCT05599984 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: M23-385
• Study Type: interventional
• Target: 288
• Locations: 10 countries
• Sites: 66

Brief 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.

Conditions

Advanced Solid Tumors

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

Outcome Measures

Primary Outcomes (14)

• 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.

  Up to Approximately 2 Years

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

  Maximum observed serum/plasma concentration of ABBV-706.

  Up to Approximately 2 Years

• Time to Cmax (Tmax) of ABBV-706

  Time to Cmax of ABBV-706.

  Up to Approximately 2 Years

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

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

  Up to Approximately 2 Years

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

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

  Up to Approximately 2 Years

• Antidrug Antibodies (ADAs)

  Incidence and concentration of anti-drug antibodies.

  Up to Approximately 2 Years

• Neutralizing Antibodies (nAbs)

  Incidence and concentration of neutralizing antibodies.

  Up to Approximately 2 Years

• 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.

  Up to Approximately 2 Years

• 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.

  Up to Approximately 2 Years

• 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.

  Up to Approximately 2 Years

• 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.

  Up to Approximately 2 Years

• Percentage of Participants with Clinical Benefit

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

  Up to Approximately 2 Years

• 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.

  Up to Approximately 2 Years

• Overall survival (OS)

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

  Up to Approximately 2 Years

Study Arms (6)

Part 1: ABBV-706 Monotherapy Dose Escalation

EXPERIMENTAL

Participants will receive escalating doses of ABBV-706 until doses for optimization are determined, as part of an approximately 1 year treatment period.

Drug: ABBV-706

Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion

EXPERIMENTAL

Participants 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 1 year treatment period..

Drug: ABBV-706

Part 3a: ABBV-706 + Budigalimab

EXPERIMENTAL

Participants will receive ABBV-706 in combination with budigalimab, as part of an approximately 1 year treatment period.

Drug: ABBV-706; Drug: Budigalimab

Part 3b: ABBV-706 + Platinum Chemotherapy

EXPERIMENTAL

Participants will receive ABBV-706 in combination with carboplatin or cisplatin, as part of an approximately 1 year treatment period.

Drug: ABBV-706; Drug: Cisplatin; Drug: Carboplatin

Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors

EXPERIMENTAL

Participants 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 1 year treatment period.

Drug: ABBV-706

Part 4b: ABBV-706 Monotherapy Dose Expansion NECs

EXPERIMENTAL

Participants 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 1 year treatment period.

Drug: ABBV-706

Interventions

ABBV-706 DRUG

Intravenous (IV) Infusion

Part 1: ABBV-706 Monotherapy Dose Escalation; Part 2: ABBV-706 Monotherapy Dose Optimization and Expansion; Part 3a: ABBV-706 + Budigalimab; Part 3b: ABBV-706 + Platinum Chemotherapy; Part 4a: ABBV-706 Monotherapy Dose Expansion CNS Tumors; Part 4b: ABBV-706 Monotherapy Dose Expansion NECs

Cisplatin DRUG

Intravenous infusion

Part 3b: ABBV-706 + Platinum Chemotherapy

Budigalimab DRUG

IV Infusion

Also known as: ABBV-181

Part 3a: ABBV-706 + Budigalimab

Carboplatin DRUG

Intravenous infusion

Part 3b: ABBV-706 + Platinum Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (66)

Banner MD Anderson Cancer Ctr /ID# 260129

Gilbert, Arizona, 85234, United States

Location

City Of Hope Comprehensive Cancer Center /ID# 271295

Duarte, California, 91030, United States

Location

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

Irvine, California, 92618, United States

Location

Yale New Haven Hospital /ID# 246647

New Haven, Connecticut, 06510, United States

Location

Georgetown University Hospital /ID# 255352

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

Location

University of Chicago Medical Center /ID# 256334

Chicago, Illinois, 60637, United States

Location

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

Fort Wayne, Indiana, 46804, United States

Location

University of Iowa Hospitals and Clinics /ID# 246638

Iowa City, Iowa, 52242, United States

Location

Barbara Ann Karmanos Cancer In /ID# 261799

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital /ID# 246648

Detroit, Michigan, 48202, United States

Location

START Midwest /ID# 251257

Grand Rapids, Michigan, 49546-7062, United States

Location

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

Kansas City, Missouri, 64111, United States

Location

Washington University-School of Medicine /ID# 246286

St Louis, Missouri, 63110, United States

Location

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

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

Location

Duke Cancer Center /ID# 246285

Durham, North Carolina, 27710, United States

Location

UH Cleveland Medical Center /ID# 246641

Cleveland, Ohio, 44106, United States

Location

Univ Oklahoma HSC /ID# 250884

Oklahoma City, Oklahoma, 73117, United States

Location

Tennessee Oncology, PLLC /ID# 246283

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center /ID# 246287

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics /ID# 248946

San Antonio, Texas, 78229, United States

Location

University of Utah /ID# 246640

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

Location

Northwest Medical Specialties - Tacoma /ID# 262801

Tacoma, Washington, 98405, United States

Location

Chris O'Brien Lifehouse /ID# 259087

Camperdown, New South Wales, 2050, Australia

Location

The Kinghorn Cancer Centre /ID# 260874

Darlinghurst, New South Wales, 2010, Australia

Location

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

Heidelberg, Victoria, 3084, Australia

Location

Peter MacCallum Cancer Ctr /ID# 259197

Melbourne, Victoria, 3000, Australia

Location

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

Beijing, Beijing Municipality, 100021, China

Location

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

Wuhan, Hubei, 430022, China

Location

First Affiliated Hospital of China Medical University /ID# 270041

Shenyang, Liaoning, 110001, China

Location

Shanghai Chest Hospital /ID# 270036

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai East Hospital /ID# 268615

Shanghai, Shanghai Municipality, 200120, China

Location

Shanghai Pulmonary Hospital /Id# 270039

Shanghai, Shanghai Municipality, 200433, China

Location

Institut Bergonie /ID# 258655

Bordeaux, Gironde, 33000, France

Location

Institut Gustave Roussy /ID# 260334

Villejuif, Val-de-Marne, 94805, France

Location

Institut Régional du Cancer Montpellier /ID# 265086

Montpellier, 34298, France

Location

Klinikum der Universitaet Muenchen - Campus Innenstadt /ID# 259412

Munich, Bavaria, 80336, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 259414

Dresden, Saxony, 01307, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 259413

Berlin, 12203, Germany

Location

The Chaim Sheba Medical Center /ID# 254915

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rambam Health Care Campus /ID# 255059

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 255147

Jerusalem, 91120, Israel

Location

Istituto Europeo Di Oncologia /ID# 256804

Milan, Milano, 20141, Italy

Location

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

Monza, Monza E Brianza, 20052, Italy

Location

National Cancer Center Hospital East /ID# 259417

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center /ID# 261279

Matsuyama, Ehime, 791-0280, Japan

Location

Hokkaido Cancer Center /ID# 261278

Sapporo, Hokkaido, 003-0804, Japan

Location

Kyoto University Hospital /ID# 259419

Kyoto, Kyoto, 606-8507, Japan

Location

Shizuoka Cancer Center /ID# 261277

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital /ID# 259418

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital Of JFCR /ID# 260132

Koto-ku, Tokyo, 135-8550, Japan

Location

Wakayama Medical University Hospital /ID# 260131

Wakayama, Wakayama, 641-8510, Japan

Location

National Cancer Center /ID# 248938

Goyang-si, Gyeonggido, 10408, South Korea

Location

CHA Bundang Medical Center /ID# 248939

Seongnam, Gyeonggido, 13496, South Korea

Location

Chonnam National University Hwasun Hospital /ID# 248943

Hwasun-gun, Jeonranamdo, 58128, South Korea

Location

Seoul National University Hospital /ID# 248940

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 248936

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 248937

Seoul, 03722, South Korea

Location

Hospital HM Nou Delfos /ID# 264851

Barcelona, 08023, Spain

Location

Hospital Universitario Vall de Hebron /ID# 258659

Barcelona, 08035, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 257294

Barcelona, 08041, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 257291

Madrid, 28034, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 257295

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre /ID# 258658

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 258657

Madrid, 28050, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 256940

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 257290

Valencia, 46010, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Central Nervous System Neoplasms; Carcinoma, Neuroendocrine; Neoplasms

Interventions

Cisplatin; budigalimab; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Nervous System Neoplasms; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: October 31, 2022
• Study Start: December 5, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6); JP (8); FR (3); DE (3); IL (3); AU (4); US (22); CN (6); IT (2); ES (9)