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AzTrials

Advanced Solid Tumors CancerPhase 1NCT03821935

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

A Phase 1 study testing Livmoniplimab and Budigalimab in people with Advanced Solid Tumors Cancer, run by AbbVie at 64 sites in 14 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
Livmoniplimab and Budigalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
64 sitesin 14 countries
Study dates
21 Feb 2019to Jun 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

  • For Dose Escalation only: Participants with an advanced solid tumor who are considered refractory to or intolerant of all existing therapy(ies) known to provide a clinical benefit for their condition. Additionally, participants who have been offered standard therapies and refused, or who are considered ineligible for standard therapies, may be eligible for this study on a case-by-case basis, after discussion with and agreement from the sponsor. Participants with pancreatic adenocarcinoma, urothelial cancer (UC), hepatocellular carcinoma (HCC), or head and neck squamous cell carcinoma (HNSCC) who are being considered for the dose escalation cohorts must also meet the histology specific eligibility criteria described below for dose expansion.
  • For Dose Expansion only participants must meet criteria specific to the type of cancer:
  • Pancreatic adenocarcinoma and have disease progression during or after 1 systemic 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 in the adjuvant, locally advanced, or metastatic setting. If the therapy was used in an adjuvant setting, disease progression must have occurred within 6 months of completing adjuvant therapy.
  • UC of the bladder and urinary tract and must have progressed following treatment with:
  • Cohort 4: A platinum-based regimen (administered in any line of therapy) and a programmed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
  • Cohort 11: One or more prior line of therapy in the locally advanced or metastatic setting. Participant must have experienced radiographic progression or relapse during or after a CPI (anti-PD1 or anti-PD-L1) for locally advanced or metastatic disease.
Show all 15Show fewer
  • HCC and must have disease progression during or after 1 prior line of systemic therapy.
  • HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) and must have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered in the recurrent or metastatic setting (progression following a PD1/PDL1 antagonist is defined as unequivocal progression on or within 3 months of the last dose of anti-PD1 or anti-PDL1 therapy).
  • Microsatellite stable colorectal cancer (MSS-CRC) [unselected] participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (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 with histologically or cytologically confirmed advanced or metastatic NSCLC who have received 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 mismatch repair proficient colorectal adenocarcinoma who have received prior fluorouracil-based combination chemotherapy regimens including oxaliplatin and irinotecan (with or without VEGF and/or EGFR targeted agents) and with a CMS4 subtype as determined by NGS of tumor biopsies. Archival tissue must be submitted for assessment of CMS4 subtype status during prescreening. Participants must have progressed on or refused available standard of care therapies. Additionally, participant who are considered not appropriate or ineligible for available standard of care therapies per investigator assessment will be eligible for this study.
  • Ovarian granulosa (OG) cell tumor: Participants with histologically confirmed advanced nonresectable or metastatic adult granulosa cell tumor of the ovary that is not amenable to curative intent surgery or radiation. Additionally, there is documentation of radiological evidence of relapse after at least 1 line of systemic chemotherapy.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • Participant has adequate bone marrow, renal, hepatic, and coagulation function.
  • Must have a viral status consistent with the requirements described in the protocol specific to type of cancer and stage of study (Dose Escalation or Dose Expansion).

Who cannot join

  • For Dose Expansion only:
  • Participants with HCC, pancreatic adenocarcinoma, or MSS-CRC having prior exposure to a prior PD-1/PD-L1 antagonist in any line of therapy.
  • Participants (except for participants with urothelial cancer or HNSCC) who have had prior exposure to immunotherapies as listed in the protocol.
  • Has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, 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 study drug.
  • Participant has unresolved AEs > Grade 1 from prior anticancer therapy except for alopecia.
  • Has a history of primary immunodeficiency, bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
Show all 11Show fewer
  • Has a known uncontrolled metastases to the central nervous system (with certain exceptions).
  • Current or prior use of immunosuppressive medication within 14 days prior to the first 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 reaction with eosinophilia and systemic symptoms (DRESS).
  • Live vaccine administration <= 28 days prior to the first dose of study drug.

Trial locations and contacts

64 sites in 14 countries.

64 sites in 14 countries

United States21 sites

  • Univ Michigan Med Ctr /ID# 221129

    Ann Arbor, Michigan, 48109

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

    Billings, Montana, 59106

  • AdventHealth Celebration /ID# 224860

    Celebration, Florida, 34747-4970

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

    Columbus, Ohio, 43210-1240

  • City of Hope National Medical Center /ID# 265620

    Duarte, California, 91010

  • Renovatio clinical /ID# 265109

    El Paso, Texas, 79915-1803

  • Carolina BioOncology Institute /ID# 208358

    Huntersville, North Carolina, 28078

  • Indiana Univ School Medicine /ID# 208384

    Indianapolis, Indiana, 46202

  • Community Health Network, Inc. /ID# 257032

    Indianapolis, Indiana, 46250-2042

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

    Irvine, California, 92618

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

    Nashville, Tennessee, 37203-5755

  • Yale University School of Medicine /ID# 208356

    New Haven, Connecticut, 06510

  • NYU Langone Medical Center /ID# 209822

    New York, New York, 10016-6402

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

    New York, New York, 10029

  • Ou Health - Stephenson Cancer Center /ID# 268826

    Oklahoma City, Oklahoma, 73104

  • Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953

    Orlando, Florida, 32804

  • NEXT Oncology /ID# 208930

    San Antonio, Texas, 78229

  • University of Washington Medical Center /ID# 268854

    Seattle, Washington, 98195

  • Highlands Oncology Group, PA /ID# 218942

    Springdale, Arkansas, 72762

  • Washington University-School of Medicine /ID# 259684

    St Louis, Missouri, 63110

  • Renovatio Clinical /ID# 265054

    The Woodlands, Texas, 77380-3181

Other trials in United States

Spain8 sites

  • Hospital Universitari Vall d'Hebron /ID# 265290

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 221106

    Barcelona, 08036

  • Clinica Universidad de Navarra - Madrid /ID# 265299

    Madrid, 28027

  • Hospital Universitario Ramón y Cajal /ID# 265298

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 220928

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro /ID# 265294

    Madrid, 28050

  • Clinica Universidad de Navarra - Pamplona /ID# 266632

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia /ID# 221107

    Valencia, 46010

Other trials in Spain

South Korea7 sites

  • Chonnam National University Hwasun Hospital /ID# 257573

    Hwasun-gun, Jeonranamdo, 58128

  • Gachon University Gil Medical Center /ID# 257572

    Incheon, Gyeonggido, 21565

  • Korea University Anam Hospital /ID# 257574

    Seoul, Seoul Teugbyeolsi, 02841

  • Seoul National University Hospital /ID# 218513

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 266799

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 265865

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 218512

    Seoul, 03722

Other trials in South Korea

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 265560

    Kaohsiung City, Kaohsiung, 833

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

    Kaohsiung City, 807

  • China Medical University Hospital /ID# 218492

    Taichung, 40447

  • Taipei Veterans General Hosp /ID# 257635

    Taipei, 11217

  • National Taiwan University Hospital /ID# 218490

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 265551

    Taoyuan City, 333

Other trials in Taiwan

Israel5 sites

  • Rambam Health Care Campus /ID# 222198

    Haifa, H_efa, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 257918

    Jerusalem, 91120

  • Rabin Medical Center /ID# 258479

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 209037

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 222199

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

France4 sites

  • Centre Jean Perrin /ID# 218669

    Clermont-Ferrand, 63011

  • Centre Leon Berard /ID# 218515

    Lyon, Rhone, 69373

  • CHU Toulouse - Hopital Purpan /ID# 218667

    Toulouse, Haute-Garonne, 31059

  • Institut Gustave Roussy /ID# 218668

    Villejuif, Val-de-Marne, 94805

Other trials in France

Japan3 sites

  • Hyogo Cancer Center /ID# 272553

    Akashi-shi, Hyōgo, 673-8558

  • National Cancer Center Hospital /ID# 209421

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 224808

    Kashiwa-shi, Chiba, 277-8577

Other trials in Japan

Poland3 sites

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

    Krakow, Lesser Poland Voivodeship, 30-348

  • Instytut Centrum Zdrowia Matki Polki /ID# 266324

    Lodz, Łódź Voivodeship, 93-338

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Australia2 sites

  • Chris O'Brien Lifehouse /ID# 213236

    Camperdown, New South Wales, 2050

  • Icon Cancer Centre /ID# 224961

    South Brisbane, Queensland, 4101

Other trials in Australia

Belgium1 site

  • Cliniques Universitaires UCL Saint-Luc /ID# 218466

    Brussels, Brussels Capital, 1200

Other trials in Belgium

Canada1 site

  • University Health Network_Princess Margaret Cancer Centre /ID# 209423

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany1 site

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

    Essen, North Rhine-Westphalia, 45136

Other trials in Germany

Italy1 site

  • Istituto Europeo Di Oncologia /Id# 266053

    Milan, Milano, 20121

Other trials in Italy

Puerto Rico1 site

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

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

Being tested
Livmoniplimab, Budigalimab
Keywords
Advanced Solid Tumors Cancer, cancer, Solid Tumors, metastatic, monotherapy, combination therapy, triple negative breast cancer (TNBC), pancreatic adenocarcinoma, urothelial cancer, hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma (HNSCC), Colorectal cancer, Ovarian granulosa cell tumors
Medical subject headings
Neoplasms, Neoplasm Metastasis, Triple Negative Breast Neoplasms, Carcinoma, Hepatocellular, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms

What participants receive

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

  • LivmoniplimabDrug

    Also called ABBV-151

    Liquid for intravenous infusion.

  • BudigalimabDrug

    Also called ABBV-181

    Lyophilized powder for solution for intravenous infusion.

Study groups in NCT03821935
Study groupRoleWhat they receive
Dose Escalation: Cohort 1 LivmoniplimabExperimentalVarious doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
Receives: Drug: Livmoniplimab
Dose Escalation: Cohort 2 Livmoniplimab + BudigalimabExperimentalVarious doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D).
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 3 Livmoniplimab + BudigalimabExperimentalParticipants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 4 Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 5 Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 6 Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 7 Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) [unselected] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 8 Livmoniplimab + BudigalimabExperimentalParticipants with non-small cell lung cancer (NSCLC) [programmed death ligand 1 (PDL1) relapsed/refractory (R/R)] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 10A Livmoniplimab + BudigalimabExperimentalParticipants with microsatellite stable colorectal cancer (MSS-CRC) [consensus molecular subtype 4 (CMS4) enriched] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 10B Livmoniplimab + BudigalimabExperimentalParticipants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 11A Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 11B Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 11C BudigalimabExperimentalParticipants with PD-1-ref urothelial cancer will receive budigalimab Dose B administered Q3W.
Receives: Drug: Budigalimab
Dose Expansion: Cohort 12A Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab
Dose Expansion: Cohort 12B Livmoniplimab + BudigalimabExperimentalParticipants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W.
Receives: Drug: Livmoniplimab; Drug: Budigalimab

What is being measured

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

  1. Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.

    Measured: Up to 28 days after the first dose of Livmoniplimab monotherapy

  2. Dose Escalation: RP2D Livmoniplimab + Budigalimab Combination Therapy

    The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.

    Measured: Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy

  3. Dose Expansion: Objective Response Rate (ORR)

    ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to approximately 6 months after the first dose date of last participant in Dose Expansion

Secondary outcomes (18)

  1. Dose Expansion: Duration of Response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 6 months after the first dose date of last participant in Dose Expansion

  2. Dose Expansion: Progression-free Survival (PFS)

    Progression-free survival is defined as the time from the participant's first dose of study treatment (livmoniplimab or budigalimab) to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 6 months after the first dose date of last participant in Dose Expansion

  3. Maximum Observed Serum Concentration (Cmax) of Livmoniplimab

    Maximum Serum Concentration (Cmax) of livmoniplimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  4. Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab

    Time to maximum serum concentration (Tmax) of livmoniplimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  5. Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Livmoniplimab

    Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of livmoniplimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  6. Terminal-phase Elimination Rate Constant (β) of Livmoniplimab

    Apparent terminal phase elimination rate constant (β or Beta) of livmoniplimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  7. Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab

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

    Measured: Up to approximately 70 days after initial dose of study drug

  8. Maximum Observed Serum Concentration (Cmax) of Budigalimab

    Maximum Serum Concentration (Cmax) of budigalimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  9. Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab

    Time to maximum serum concentration (Tmax) of budigalimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  10. Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab

    Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCτ) of budigalimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  11. Terminal-phase Elimination Rate Constant (β) of Budigalimab

    Apparent terminal phase elimination rate constant (β or Beta) of budigalimab.

    Measured: Up to approximately 70 days after initial dose of study drug

  12. Terminal Phase Elimination Half-life (t1/2) of Budigalimab

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

    Measured: Up to approximately 70 days after initial dose of study drug

  13. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to approximately 9 months after the first dose date of last participant

  14. Change in Vital Signs

    Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.

    Measured: Up to approximately 6 months after the first dose date of last participant

  15. Change in Laboratory Parameters

    Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.

    Measured: Up to approximately 6 months after the first dose date of last participant

  16. Change in Electrocardiogram (ECG)

    12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

    Measured: Up to approximately 6 months after the first dose date of last participant

  17. Incidence of Anti-drug Antibody (ADA)

    The number of participants with anti-drug antibodies.

    Measured: Up to approximately 6 months after the first dose date of last participant

  18. Dose Expansion Cohorts 10 to 12: Overall Survival (OS)

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

    Measured: Up to approximately 6 months after the first dose date of last participant in Cohorts 10 to 12

Timeline

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

  1. First posted30 Jan 2019
  2. Study start21 Feb 2019
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821935
Sponsor's protocol ID
M19-345
Other IDs
2023-508281-15-00, 2023
Status last verified
May 2025
First submitted
28 Jan 2019
Last updated
25 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shimizu T, Powderly J, Abdul Razak A, LoRusso P, Miller KD, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ss1 complex, as monotherapy and in combination with the anti-PD-1 antibody budigalimab in patients with advanced solid tumors. Front Oncol. 2024 Oct 29;14:1376551. doi: 10.3389/fonc.2024.1376551. eCollection 2024.

    PubMed 39534099

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Livmoniplimab and Budigalimab in people with Advanced Solid Tumors Cancer, run by AbbVie at 64 sites in 14 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 15 inclusion and 11 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Spain, South Korea, Taiwan, Israel and 9 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?

Dose Escalation: Recommended Phase 2 Dose (RP2D) Livmoniplimab Monotherapy (time frame: Up to 28 days after the first dose of Livmoniplimab monotherapy). The study lists 3 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 NCT03821935, 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 25 May 2025.

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