Breast Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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, 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.
Urothelial cancer of the bladder and urinary tract and must have progressed following treatment with 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).
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).
CRC participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (as determined by PCR/NGS or IHC, respectively) who have received 1-2 prior chemotherapy regimens.
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.
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 microsatellite stable colorectal cancer (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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

260

Study ID:

NCT03821935

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 31 Locations for this study

See Locations Near You

Yale University /ID# 208356
New Haven Connecticut, 06510, United States
AdventHealth Celebration /ID# 224860
Celebration Florida, 34747, United States
AdventHealth Cancer Institute - Orlando /ID# 226953
Orlando Florida, 32804, United States More Info
Site Coordinator
Contact
844-663-3742
Indiana Univ School Medicine /ID# 208384
Indianapolis Indiana, 46202, United States
Univ Michigan Med Ctr /ID# 221129
Ann Arbor Michigan, 48109, United States
NYU Langone Medical Center /ID# 209822
New York New York, 10016, United States
Carolina BioOncology Institute /ID# 208358
Huntersville North Carolina, 28078, United States
The Ohio State University - The James /ID# 217611
Columbus Ohio, 43210, United States More Info
Site Coordinator
Contact
844-663-3742
NEXT Oncology /ID# 208930
San Antonio Texas, 78229, United States
Chris O'Brien Lifehouse /ID# 213236
Camperdown New South Wales, 2050, Australia
Icon Cancer Centre /ID# 224961
South Brisbane Queensland, 4101, Australia
UCL Saint-Luc /ID# 218466
Woluwe-Saint-Lambert Bruxelles-Capitale, 1200, Belgium
Princess Margaret Cancer Centre /ID# 209423
Toronto Ontario, M5G 2, Canada
CHU Toulouse - Hopital Purpan /ID# 218667
TOULOUSE Cedex 9 Haute-Garonne, 31059, France
Centre Leon Berard /ID# 218515
Lyon CEDEX 08 Rhone, 69373, France
Institut Gustave Roussy /ID# 218668
Villejuif Cedex Val-de-Marne, 94805, France
Centre Jean Perrin /ID# 218669
Clermont Ferrand , 63011, France
The Chaim Sheba Medical Center /ID# 209037
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 222199
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Rambam Health Care Campus /ID# 222198
Haifa , 31096, Israel
National Cancer Center Hospital East /ID# 224808
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital /ID# 209421
Chuo-ku Tokyo, 104-0, Japan
Yonsei University Health System Severance Hospital /ID# 218512
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul National University Hospital /ID# 218513
Seoul , 03080, Korea, Republic of
Pan American Center for Oncology Trials, LLC /ID# 217475
Rio Piedras , 00935, Puerto Rico More Info
Site Coordinator
Contact
844-663-3742
Hospital Clinic de Barcelona /ID# 221106
Barcelona , 08036, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 220928
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre /ID# 248366
Madrid , 28041, Spain
Hospital Clinico Universitario de Valencia /ID# 221107
Valencia , 46010, Spain
China Medical University Hospital /ID# 218492
Taichung City , 40447, Taiwan
National Taiwan University Hospital /ID# 218490
Taipei City , 100, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

260

Study ID:

NCT03821935

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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