Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

Last updated: May 20, 2025
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neoplasms

Treatment

Livmoniplimab

Budigalimab

Clinical Study ID

NCT03821935
M19-345
2018-004303-40
2023-508281-15-00
  • Ages > 18
  • All Genders

Study Summary

The study will determine the recommended Phase 2 dose (RP2D) of livmoniplimab (ABBV-151) administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of livmoniplimab alone and in combination with budigalimab. The study will consist of 2 parts: dose escalation and dose expansion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For Dose Escalation only: Participants with an advanced solid tumor who areconsidered refractory to or intolerant of all existing therapy(ies) known to providea clinical benefit for their condition. Additionally, participants who have beenoffered standard therapies and refused, or who are considered ineligible forstandard therapies, may be eligible for this study on a case-by-case basis, afterdiscussion with and agreement from the sponsor. Participants with pancreaticadenocarcinoma, urothelial cancer (UC), hepatocellular carcinoma (HCC), or head andneck squamous cell carcinoma (HNSCC) who are being considered for the doseescalation cohorts must also meet the histology specific eligibility criteriadescribed below for dose expansion.

  • For Dose Expansion only participants must meet criteria specific to the type ofcancer:

  • Pancreatic adenocarcinoma and have disease progression during or after 1systemic therapy (gemcitabine monotherapy or in combination with other agents,FOLFIRINOX [or another regimen including both 5-fluorouracil and oxaliplatin],capecitabine monotherapy or in combination with other agents) administered inthe adjuvant, locally advanced, or metastatic setting. If the therapy was usedin an adjuvant setting, disease progression must have occurred within 6 monthsof completing adjuvant therapy.

  • UC of the bladder and urinary tract and must have progressed followingtreatment with:

  • Cohort 4: A platinum-based regimen (administered in any line of therapy) and aprogrammed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administeredin the recurrent or metastatic setting (progression following a PD1/PDL1antagonist is defined as unequivocal progression on or within 3 months of thelast dose of anti-PD1 or anti-PDL1 therapy).

  • Cohort 11: One or more prior line of therapy in the locally advanced ormetastatic setting. Participant must have experienced radiographic progressionor relapse during or after a CPI (anti-PD1 or anti-PD-L1) for locally advancedor metastatic disease.

  • HCC and must have disease progression during or after 1 prior line of systemictherapy.

  • HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) andmust have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered inthe recurrent or metastatic setting (progression following a PD1/PDL1antagonist is defined as unequivocal progression on or within 3 months of thelast dose of anti-PD1 or anti-PDL1 therapy).

  • Microsatellite stable colorectal cancer (MSS-CRC) [unselected] participantswith microsatellite stable or mismatch repair proficient colorectaladenocarcinoma (as determined by polymerase chain reaction (PCR)/Next-Generation sequencing (NGS) or immunohistochemistry (IHC),respectively) who have received 1-2 prior chemotherapy regimens.

  • Non-small cell lung cancer (NSCLC) relapsed/refractory (R/R): Participants withhistologically or cytologically confirmed advanced or metastatic NSCLC who havereceived 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody,administered either concurrently or sequentially in the metastatic setting.

  • MSS-CRC (CMS4 enriched): Participants with microsatellite stable or mismatchrepair proficient colorectal adenocarcinoma who have received priorfluorouracil-based combination chemotherapy regimens including oxaliplatin andirinotecan (with or without VEGF and/or EGFR targeted agents) and with a CMS4subtype as determined by NGS of tumor biopsies. Archival tissue must besubmitted for assessment of CMS4 subtype status during prescreening.Participants must have progressed on or refused available standard of caretherapies. Additionally, participant who are considered not appropriate orineligible for available standard of care therapies per investigator assessmentwill be eligible for this study.

  • Ovarian granulosa (OG) cell tumor: Participants with histologically confirmedadvanced nonresectable or metastatic adult granulosa cell tumor of the ovarythat is not amenable to curative intent surgery or radiation. Additionally,there is documentation of radiological evidence of relapse after at least 1line of systemic chemotherapy.

  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0to 1.

  • Participant has adequate bone marrow, renal, hepatic, and coagulation function.

  • Must have a viral status consistent with the requirements described in the protocolspecific to type of cancer and stage of study (Dose Escalation or Dose Expansion).

Exclusion

Exclusion Criteria:

  • For Dose Expansion only:

  • Participants with HCC, pancreatic adenocarcinoma, or MSS-CRC having priorexposure to a prior PD-1/PD-L1 antagonist in any line of therapy.

  • Participants (except for participants with urothelial cancer or HNSCC) who havehad prior exposure to immunotherapies as listed in the protocol.

  • Has received anticancer therapy including chemotherapy, immunotherapy, radiationtherapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives or 28 days (whichever is shorter), prior to the first dose of the studydrug.

  • Participant has unresolved AEs > Grade 1 from prior anticancer therapy except foralopecia.

  • Has a history of primary immunodeficiency, bone marrow transplantation, solid organtransplantation, or previous clinical diagnosis of tuberculosis.

  • Has a known uncontrolled metastases to the central nervous system (with certainexceptions).

  • Current or prior use of immunosuppressive medication within 14 days prior to thefirst dose of the study drug.

  • Has clinically significant uncontrolled condition(s).

  • History of inflammatory bowel disease, interstitial lung disease or pneumonitis,myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reactionwith eosinophilia and systemic symptoms (DRESS).

  • Live vaccine administration <= 28 days prior to the first dose of study drug.

Study Design

Total Participants: 364
Treatment Group(s): 2
Primary Treatment: Livmoniplimab
Phase: 1
Study Start date:
February 21, 2019
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Chris O'Brien Lifehouse /ID# 213236

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Icon Cancer Centre /ID# 224961

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Cliniques Universitaires UCL Saint-Luc /ID# 218466

    Bruxelles, Bruxelles-Capitale 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires UCL Saint-Luc /ID# 218466

    Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
    Belgium

    Site Not Available

  • UCL Saint-Luc /ID# 218466

    Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
    Belgium

    Active - Recruiting

  • Princess Margaret Cancer Centre /ID# 209423

    Toronto, Ontario M5G 2M9
    Canada

    Completed

  • University Health Network_Princess Margaret Cancer Centre /ID# 209423

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • CHU Toulouse - Hopital Purpan /ID# 218667

    TOULOUSE Cedex 9, Haute-Garonne 31059
    France

    Site Not Available

  • Hopital Universitaire Purpan /ID# 218667

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • Centre Leon Berard /ID# 218515

    Lyon CEDEX 08, Rhone 69373
    France

    Site Not Available

  • Institut Gustave Roussy /ID# 218668

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Institut Gustave Roussy /ID# 218668

    Villejuif Cedex, Val-de-Marne 94805
    France

    Site Not Available

  • Centre Jean Perrin /ID# 218669

    Clermont Ferrand, 63011
    France

    Site Not Available

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung /ID# 269587

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Rambam Health Care Campus /ID# 222198

    Haifa, H_efa 3109601
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 209037

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 222199

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center /ID# 222199

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 258479

    Haifa, 4941492
    Israel

    Active - Recruiting

  • Hadassah Medical Center /ID# 257918

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 257918

    Jerusalem, 91120
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 258479

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Istituto Europeo Di Oncologia /Id# 266053

    Milan, Milano 20121
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 266054

    Rome, Roma 00168
    Italy

    Site Not Available

  • National Cancer Center Hospital East /ID# 224808

    Kashiwa-shi, Chiba 277-8577
    Japan

    Site Not Available

  • Hyogo Cancer Center /ID# 272553

    Akashi-shi, Hyogo 673-8558
    Japan

    Site Not Available

  • National Cancer Center Hospital /ID# 209421

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Gachon University Gil Medical Center /ID# 257572

    Incheon, Gyeonggido 21565
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center /ID# 257572

    남동구, Gyeonggido 21565
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital /ID# 257573

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Asan Medical Center /ID# 266799

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital /ID# 257574

    Seoul, Seoul Teugbyeolsi 02841
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center /ID# 265865

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital /ID# 218513

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System Severance Hospital /ID# 218512

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki /ID# 266324

    Lodz, Lodzkie 93-338
    Poland

    Site Not Available

  • Jagiellonskie Centrum Innowacji Sp. z o.o. /ID# 266194

    Krakow, Malopolskie 30-348
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 266147

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Pan American Center for Oncology Trials, LLC /ID# 217475

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Clinica Universidad de Navarra - Pamplona /ID# 266632

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona /ID# 221106

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron /ID# 265290

    Barcelona, 08035
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Madrid /ID# 265299

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 220928

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro /ID# 265294

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal /ID# 265298

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia /ID# 221107

    Valencia, 46010
    Spain

    Site Not Available

  • Hosp Clin Univ de Valencia /ID# 221107

    València, 46010
    Spain

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital /ID# 265560

    Kaohsiung City, Kaohsiung 833
    Taiwan

    Site Not Available

  • National Taiwan University Hospital /ID# 218490

    Taipei City, Taipei 100
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257634

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 218492

    Taichung, 40447
    Taiwan

    Site Not Available

  • China Medical University Hospital /ID# 218492

    Taichung City, 40447
    Taiwan

    Site Not Available

  • Taipei Veterans General Hosp /ID# 257635

    Taipei, 11217
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital /ID# 265551

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Highlands Oncology Group, PA /ID# 218942

    Springdale, Arkansas 72762
    United States

    Site Not Available

  • City of Hope National Medical Center /ID# 265620

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785

    Irvine, California 92618
    United States

    Site Not Available

  • Univ California, San Francisco /ID# 221131

    San Francisco, California 94143-2204
    United States

    Site Not Available

  • Yale University /ID# 208356

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale University School of Medicine /ID# 208356

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • AdventHealth Celebration /ID# 224860

    Celebration, Florida 34747-4970
    United States

    Site Not Available

  • AdventHealth Celebration /ID# 224860

    Kissimmee, Florida 34747-4970
    United States

    Site Not Available

  • AdventHealth Cancer Institute - Orlando /ID# 226953

    Orlando, Florida 32804
    United States

    Completed

  • Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953

    Orlando, Florida 32804
    United States

    Site Not Available

  • Community Health Network, Inc. /ID# 257032

    Indianapolis, Indiana 46250-2042
    United States

    Site Not Available

  • Indiana Univ School Medicine /ID# 208384

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Univ Michigan Med Ctr /ID# 221129

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 259684

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171

    Billings, Montana 59106
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai /ID# 264653

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Medical Center /ID# 209822

    New York, New York 10016-6402
    United States

    Site Not Available

  • Carolina BioOncology Institute /ID# 208358

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • The Ohio State University - The James /ID# 217611

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • Ou Health - Stephenson Cancer Center /ID# 268826

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Sarah Cannon Research Institute (SMO/Network/Consortium) /ID# 264900

    Nashville, Tennessee 37203-5755
    United States

    Site Not Available

  • Sarah Cannon Research Institute - Main /ID# 264900

    Nashville, Tennessee 37203-5755
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute /ID# 264900

    Nashville, Tennessee 37203-5755
    United States

    Active - Recruiting

  • Renovatio clinical /ID# 265109

    El Paso, Texas 79915-1803
    United States

    Site Not Available

  • NEXT Oncology /ID# 208930

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Renovatio Clinical /ID# 265054

    The Woodlands, Texas 77380-3181
    United States

    Site Not Available

  • University of Washington Medical Center /ID# 268854

    Seattle, Washington 98195
    United States

    Site Not Available

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