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ABBV-368

Phase 1

Advanced Solid Tumors Cancer | Small molecule | Oncology |AbbVie Inc.|Last Updated: Feb 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment169
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04196283A 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 CarcinomaPHASE1 COMPLETED 30Jan 22, 2020Oct 27, 2022Feb 27, 202326 United States, France +4
NCT03071757A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 139Mar 21, 2017Apr 13, 2022Apr 28, 202227 United States, France +4
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs)
Up to approximately 2 years following the first dose

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.

Change in Vital Signs
Up to approximately 2 years following the first dose

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

Change in Clinical Laboratory Test Results
Up to approximately 2 years following the first dose

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

Maximum Observed Serum Concentration (Cmax) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Maximum Serum Concentration (Cmax) of ABBV-368

Time to Maximum Serum Concentration (Tmax) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Serum Concentration-Time Curve of ABBV-368 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of ABBV-368
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Plasma Concentration (Cmax) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod

Time to Maximum Plasma Concentration (Tmax) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Area Under Plasma Concentration-Time Curve of Tilsotolimod From Time 0 to the Time of Last Measurable Concentration (AUCt)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal-Phase Elimination Rate Constant (β) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Terminal Half-Life (t1/2) of Tilsotolimod
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)
Maximum Observed Serum Concentration (Cmax) of ABBV-181 (Arm 3 Only)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Maximum Observed Serum Concentration (Cmax) of ABBV-181

Time to Maximum Serum Concentration (Tmax) of ABBV-181 (Arm 3 Only)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Time to Maximum Serum Concentration (Tmax) of ABBV-181

Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt) (Arm 3 Only)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)

Terminal-Phase Elimination Rate Constant (β) of ABBV-181 (Arm 3 Only)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Terminal-Phase Elimination Rate Constant (β) of ABBV-181

Terminal Half-Life (t1/2) of ABBV-181 (Arm 3 Only)
Cycle 1 through Cycle 3 (each cycle is approximately 28 days)

Terminal Half-Life (t1/2) of ABBV-181

Area under the serum concentration-time curve (AUC) of ABBV-368
Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination

Area under the serum concentration-time curve of ABBV-368

Maximum tolerated dose (MTD) of ABBV-368 when administered as monotherapy or in combination with ABBV-181
Up to 1 year

The MTD of ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study.

Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181
Up to 18 months

Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be established during the Dose expansion of the study

Time to Cmax (Tmax) of ABBV-368
Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination

Time to Cmax of ABBV-368

Terminal phase elimination rate constant (β) of ABBV-368
Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination

Terminal phase elimination rate constant of ABBV-368

Number of Participants With Adverse Events
Multiple time points in each cycle (each cycle is 28 days), throughout study completion, an average of 2 years, or participant becomes lost to follow up, or study termination

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Secondary Endpoints
Objective Response Rate (ORR)
Up to approximately 2 years following the first dose
Clinical Benefit Rate (CBR)
Up to approximately 2 years following the first dose
Time to Response (TTR)
Up to approximately 2 years following the first dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: ABBV-368 + TilsotolimodEXPERIMENTALParticipants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol.
Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxelEXPERIMENTALParticipants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol.
Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181EXPERIMENTALParticipants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol.
Part 1A: Monotherapy Dose EscalationEXPERIMENTALPart 1A: ABBV-368 (various dose levels) intravenous administration every 2 weeks (Q2W). One cycle of treatment is 28 days, thus there will be 2 doses with ABBV-368 per cycle.
Part 2A: Monotherapy Cohort ExpansionEXPERIMENTALPart 2A: Additional participants (triple negative breast cancer \[TNBC\]) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W.
Part 2B: Combination Therapy Cohort ExpansionEXPERIMENTALPart 2B: Additional participants (with Head and Neck carcinoma) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W plus ABBV-181.
Part 3A: 18F-AraG Imaging Substudy in TNBC ParticipantsEXPERIMENTALPart 3A: Additional participants (with TNBC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181.
Part 3B: 18F-AraG Imaging Substudy in HNSCC ParticipantsEXPERIMENTALPart 3B: Additional participants (with HNSCC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181.
Interventions
NameTypeDescription
ABBV-368DRUGIntravenous (IV) infusion
TilsotolimodDRUGIntratumoral (IT) injection
Nab-paclitaxelDRUGIntravenous (IV) infusion
ABBV-181DRUGIntravenous (IV) infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Participants should weigh at least 35 kg. * Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of \>= 3 months. * Participant have \>= 1 lesion accessible for intratumoral injection. * Histologically or cytologically confirmed R/M HNSCC (of t...

Countries:United StatesFranceGermanyIsraelNetherlandsSpainJapanPuerto RicoTaiwan
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