Locally Advanced or Metastatic Solid Tumors
Conditions
Interventions
investigational material(s)
Generic name etc : ABBV-151
INN of investigational material : Livmoniplimab
Therapeutic category code : 429 Other antitumor agents
Generic name etc : ABBV-181
INN of invest
Sponsors
AbbVie G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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. - 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. Participants must meet criteria specific to the type of cancer: Cohort 3;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. Cohort 4;UC 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). Cohort 5;HCC and must have disease progression during or after 1 prior line of systemic therapy. Cohort 6;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). Cohort 7;Microsatellite stable colorectal cancer (MSS-CRC) [unselected] participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma (as determined by PCR/Next-Generation sequencing (NGS) or immunohistochemistry (IHC), respectively) who have received 1-2 prior chemotherapy regimens. Cohort 8;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. Cohort 10;MSS-CRC (CMS4 enriched): Participants with microsatellite stable or mismatch repair proficient colorectal adenocarcinoma who have received prior fluorouracil-based combination chemotherapy regimens including oxa
Exclusion criteria
Exclusion criteria: - 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) including but not limited to the following: - Grade >=3 peripheral neuropathy (unrelated to prior anticancer therapy). - Active uncontrolled infection. - Symptomatic congestive heart failure. - Unstable angina pectoris or cardiac arrhythmia. - Psychiatric illness/social situation that would limit compliance with the study. - History of or concurrent interstitial lung disease. - 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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. [Time Frame: 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. [Time Frame: 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. [Time Frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion] | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. 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. [Time Frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion] 5. 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. [Time Frame: Up to approximately 6 months after the first dose date of last participant in Dose Expansion] 6. Maximum Observed Serum Concentration (Cmax) of Livmoniplimab Maximum Serum Concentration (Cmax) of livmoniplimab. [Time Frame: Up to approximately 70 days after initial dose of study drug] 7. Time to Maximum Observed Serum Concentration (Tmax) of Livmoniplimab Time to maximum serum concentration (Tmax) of livmoniplimab. [Time Frame: Up to approximately 70 days after initial dose of study drug] 8. Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCtau) of Livmoniplimab Area under the serum concentration-time curve from time 0 to the time of the last measurable concentration (AUCtau) of livmoniplimab. [Time Frame: Up to approximately 70 days after initial dose of study drug] 9. Terminal-phase Elimination Rate Constant (beta) of Livmoniplimab Apparent terminal phase elimination rate constant (beta) of livmoniplimab. [Time Frame: Up to approximately 70 days after initial dose of study drug] 10. Terminal Phase Elimination Half-life (t1/2) of Livmoniplimab Terminal phase elimination half-life (t1/2) of livmoniplimab. [Time Frame: Up to approximately 70 days after initial dose of study drug] 11. Maximum Observed Serum Concentration (Cmax) of Budigalimab Maximum Serum Concentration (Cmax) of budigalimab. [Time Frame: Up | — |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, Taiwan, United States
Contacts
Public ContactPatients and HCP Contact
AbbVie G.K.
Outcome results
None listed