Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03821935
Other study ID # M19-345
Secondary ID 2023-508281-15-0
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 21, 2019
Est. completion date June 23, 2027

Study information

Verified date April 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study will consist of 2 parts: dose escalation and dose expansion.


Recruitment information / eligibility

Status Recruiting
Enrollment 362
Est. completion date June 23, 2027
Est. primary completion date June 23, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. - 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). Exclusion Criteria: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Livmoniplimab
Liquid for intravenous infusion.
Budigalimab
Lyophilized powder for solution for intravenous infusion.

Locations

Country Name City State
Australia Chris O'Brien Lifehouse /ID# 213236 Camperdown New South Wales
Australia Icon Cancer Centre /ID# 224961 South Brisbane Queensland
Belgium Cliniques Universitaires UCL Saint-Luc /ID# 218466 Woluwe-Saint-Lambert Bruxelles-Capitale
Canada Princess Margaret Cancer Centre /ID# 209423 Toronto Ontario
France Centre Jean Perrin /ID# 218669 Clermont Ferrand
France Centre Leon Berard /ID# 218515 Lyon CEDEX 08 Rhone
France CHU Toulouse - Hopital Purpan /ID# 218667 TOULOUSE Cedex 9 Haute-Garonne
France Institut Gustave Roussy /ID# 218668 Villejuif Cedex Val-de-Marne
Israel Rabin Medical Center /ID# 258479 Haifa
Israel Rambam Health Care Campus /ID# 222198 Haifa H_efa
Israel Hadassah Medical Center-Hebrew University /ID# 257918 Jerusalem
Israel The Chaim Sheba Medical Center /ID# 209037 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 222199 Tel Aviv Tel-Aviv
Japan National Cancer Center Hospital /ID# 209421 Chuo-ku Tokyo
Japan National Cancer Center Hospital East /ID# 224808 Kashiwa-shi Chiba
Korea, Republic of Chonnam National University Hwasun Hospital /ID# 257573 Hwasun-gun Jeonranamdo
Korea, Republic of Gachon University Gil Medical Center /ID# 257572 Incheon Gyeonggido
Korea, Republic of Korea University Anam Hospital /ID# 257574 Seoul
Korea, Republic of Seoul National University Hospital /ID# 218513 Seoul
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 218512 Seoul Seoul Teugbyeolsi
Puerto Rico Pan American Center for Oncology Trials, LLC /ID# 217475 Rio Piedras
Spain Hospital Clinic de Barcelona /ID# 221106 Barcelona
Spain Hospital Universitario Fundacion Jimenez Diaz /ID# 220928 Madrid
Spain Hospital Clinico Universitario de Valencia /ID# 221107 Valencia
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257634 Kaohsiung
Taiwan China Medical University Hospital /ID# 218492 Taichung
Taiwan Taipei Veterans General Hosp /ID# 257635 Taipei
Taiwan National Taiwan University Hospital /ID# 218490 Taipei City
United States Univ Michigan Med Ctr /ID# 221129 Ann Arbor Michigan
United States AdventHealth Celebration /ID# 224860 Celebration Florida
United States The Ohio State University - The James /ID# 217611 Columbus Ohio
United States Carolina BioOncology Institute /ID# 208358 Huntersville North Carolina
United States Community Health Network, Inc. /ID# 257032 Indianapolis Indiana
United States Indiana Univ School Medicine /ID# 208384 Indianapolis Indiana
United States Yale University School of Medicine /ID# 208356 New Haven Connecticut
United States NYU Langone Medical Center /ID# 209822 New York New York
United States Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953 Orlando Florida
United States Washington University-School of Medicine /ID# 259684 Saint Louis Missouri
United States NEXT Oncology /ID# 208930 San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Israel,  Japan,  Korea, Republic of,  Puerto Rico,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 28 days after the first dose of Livmoniplimab monotherapy
Primary 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. Up to 28 days after the first dose of Livmoniplimab and Budigalimab combination therapy
Primary 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. Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Secondary 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. Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Secondary 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. Up to approximately 6 months after the first dose date of last participant in Dose Expansion
Secondary Maximum Observed Serum Concentration (Cmax) of Livmoniplimab Maximum Serum Concentration (Cmax) of livmoniplimab. Up to approximately 70 days after initial dose of study drug
Secondary Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab Time to maximum serum concentration (Tmax) of livmoniplimab. Up to approximately 70 days after initial dose of study drug
Secondary Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCt) of Livmoniplimab Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCt) of livmoniplimab. Up to approximately 70 days after initial dose of study drug
Secondary Terminal-phase Elimination Rate Constant (ß) of Livmoniplimab Apparent terminal phase elimination rate constant (ß or Beta) of livmoniplimab. Up to approximately 70 days after initial dose of study drug
Secondary Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab Terminal phase elimination half-life (t1/2) of livmoniplimab. Up to approximately 70 days after initial dose of study drug
Secondary Maximum Observed Serum Concentration (Cmax) of Budigalimab Maximum Serum Concentration (Cmax) of budigalimab. Up to approximately 70 days after initial dose of study drug
Secondary Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab Time to maximum serum concentration (Tmax) of budigalimab. Up to approximately 70 days after initial dose of study drug
Secondary Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCt) of Budigalimab Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCt) of budigalimab. Up to approximately 70 days after initial dose of study drug
Secondary Terminal-phase Elimination Rate Constant (ß) of Budigalimab Apparent terminal phase elimination rate constant (ß or Beta) of budigalimab. Up to approximately 70 days after initial dose of study drug
Secondary Terminal Phase Elimination Half-life (t1/2) of Budigalimab Terminal phase elimination half-life (t1/2) of budigalimab. Up to approximately 70 days after initial dose of study drug
Secondary 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. Up to approximately 9 months after the first dose date of last participant
Secondary 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. Up to approximately 6 months after the first dose date of last participant
Secondary Change in Laboratory Parameters Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported. Up to approximately 6 months after the first dose date of last participant
Secondary Change in Electrocardiogram (ECG) 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration. Up to approximately 6 months after the first dose date of last participant
Secondary Incidence of Anti-drug Antibody (ADA) The number of participants with anti-drug antibodies. Up to approximately 6 months after the first dose date of last participant
Secondary Dose Expansion Cohorts 10 to 12: Overall Survival (OS) OS is defined as time from first study treatment to death due to any cause. Up to approximately 6 months after the first dose date of last participant in Cohorts 10 to 12
See also
  Status Clinical Trial Phase
Completed NCT03234712 - A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) Phase 1
Completed NCT03311477 - A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors Phase 1
Completed NCT02955251 - A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors Phase 1
Completed NCT03071757 - A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT04417465 - First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors Phase 1
Terminated NCT03145909 - A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR) Phase 1
Completed NCT04196283 - A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Phase 1
Active, not recruiting NCT02099058 - A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors Phase 1
Active, not recruiting NCT04721015 - Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors Phase 1
Active, not recruiting NCT02988960 - A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05929235 - A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma Phase 1

External Links