Advanced Solid Tumors CancerPhase 1NCT03071757
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
A Phase 1 study testing ABBV-368 and ABBV-181 in people with Advanced Solid Tumors Cancer, run by AbbVie at 27 sites in 6 countries.
Trial summary
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. 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?
- ABBV-368 and ABBV-181
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 21 Mar 2017to 13 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants must have histologic or cytology diagnosis of a known immunogenic solid tumor, as described for Part 1 Dose Escalation and Part 2 Cohort Expansion:
- Part 1 Dose Escalation:
- Participants with advanced or metastatic solid tumors that have exhausted standard treatment for their incurable disease and for whom there is currently no programmed cell death 1 (PD-1)/ programmed cell death-ligand 1 (PD-L1) approved therapy, with immunogenic type tumors such as, but not limited to triple negative breast cancer (TNBC), ovarian cancer, small cell lung cancer, mesothelioma, and cholangiocarcinoma.
- Participants who are refractory to a PD-1/PD-L1 agent, with tumor types such as melanoma, NSCLC, platinum-pretreated head and neck cancer, second line bladder and RCC.
- Part 2A and 2B Cohort Expansion:
- 2A : TNBC ABBV-368 monotherapy cohorts: Subjects with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease.
Show all 13Show fewer
- 2B : Head and Neck cohort: Participants with recurrent squamous cell head and neck carcinoma that are not candidates for curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
- Part 3A and 3B Imaging Substudy:
- 3A: Participants with locally advanced or metastatic TNBC that have exhausted standard treatment for their incurable disease and are treatment naïve to a PD-1/PD-L1 targeting agent.
- 3B: Participants with recurrent HNSCC that are not candidates for curative treatment with local or systemic therapy, or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. Participants must be treatment naïve to a PD-1/PD-L1 targeting agent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Participants must have immune-related Response Evaluation Criteria for Solid Tumors (iRECIST) evaluable or measurable disease in the PART 1 and measurable disease per iRECIST in PART 2
- Adequate bone marrow, kidney and liver function.
Who cannot join
- Received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 21 days prior to the first dose of ABBV-368.
- Prior treatment with an OX40 targeting agent.
- has known uncontrolled metastases to the central nervous system (CNS).
- History of active autoimmune disorders and other conditions that compromise or impair the immune system.
- Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active hepatitis A, B or C. Subjects who have a history of hepatitis B or C who have documented cures after anti-viral therapy may be enrolled.
- Has received live vaccine within 28 days prior to the first dose of study drug.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
United States10 sites
University of Virginia /ID# 212895
Charlottesville, Virginia, 22908
University of Texas Southwestern Medical Center /ID# 201934
Dallas, Texas, 75390-7208
Virginia Cancer Specialists - Fairfax /ID# 160787
Fairfax, Virginia, 22031
Greenville Hospital System /ID# 160785
Greenville, South Carolina, 29605
Carolina BioOncology Institute /ID# 160786
Huntersville, North Carolina, 28078
Moores Cancer Center at UC San Diego /ID# 201334
La Jolla, California, 92093
Yale University /ID# 207895
New Haven, Connecticut, 06510
University of California, Davis Comprehensive Cancer Center /ID# 201342
Sacramento, California, 95817
South Texas Accelerated Research Therapeutics /ID# 160788
San Antonio, Texas, 78229
Stanford University /ID# 206949
Stanford, California, 94305
Spain7 sites
Hospital Duran i Reynals /ID# 205997
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital General Universitario Gregorio Maranon /ID# 205999
Madrid, 28007
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 205996
Madrid, 28027
Hospital Universitario Fundacion Jimenez Diaz /ID# 211500
Madrid, 28040
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 206973
Majadahonda, Madrid, 28222
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 208879
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Valencia /ID# 211499
Valencia, 46010
France4 sites
Centre Leon Berard /ID# 165037
Lyon, Rhone, 69373
AP-HM - Hopital de la Timone /ID# 165036
Marseille, Bouches-du-Rhone, 13385
Institut Curie /ID# 165038
Paris, Île-de-France Region, 75248
Institut Gustave Roussy /ID# 165035
Villejuif, Val-de-Marne, 94805
Taiwan3 sites
National Cheng Kung University Hospital /ID# 164002
Tainan, 704
National Taiwan University Hospital /ID# 164000
Taipei, 100
Taipei Medical University Hospital /ID# 164001
Taipei, 11031
Japan2 sites
National Cancer Center Hospital /ID# 214531
Chuo-ku, Tokyo, 104-0045
National Cancer Center Hospital East /ID# 214530
Kashiwa-shi, Chiba, 277-8577
Puerto Rico1 site
Pan American Center for Oncology Trials, LLC /ID# 213809
Rio Piedras, 00935
About this study
Official title: A Multicenter, Phase 1, Open-Label, Dose-Escalation 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
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Read the detailed description
Recruitment is closed in Part 1A; subjects are in maintenance
- Conditions
- Advanced Solid Tumors Cancer
- Being tested
- ABBV-368, ABBV-181
- Keywords
- Solid Tumors, Cancer, Metastatic Solid Tumors, Advanced Solid Tumors, Triple negative breast cancer (TNBC), Ovarian cancer, Hepatocellular carcinoma (HCC), Gastric cancer, Mesothelioma, Small cell lung cancer (SCLC), Cholangiocarcinoma, Merkel cell carcinoma, Melanoma, Non-small cell lung cancer (NSCLC), 2'-Deoxy-2'-[18F]Fluoro-9-β-DArabinofuranosylguanine (18F-AraG)
- Medical subject headings
- Neoplasms, Triple Negative Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Hepatocellular, Stomach Neoplasms, Mesothelioma, Small Cell Lung Carcinoma, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-368Drug
Intravenous infusion
ABBV-181Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Monotherapy Dose Escalation | Experimental | Part 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. Receives: Drug: ABBV-368 |
| Part 2A: Monotherapy Cohort Expansion | Experimental | Part 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. Receives: Drug: ABBV-368 |
| Part 2B: Combination Therapy Cohort Expansion | Experimental | Part 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. Receives: Drug: ABBV-368; Drug: ABBV-181 |
| Part 3A: 18F-AraG Imaging Substudy in TNBC Participants | Experimental | Part 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. Receives: Drug: ABBV-368; Drug: ABBV-181 |
| Part 3B: 18F-AraG Imaging Substudy in HNSCC Participants | Experimental | Part 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. Receives: Drug: ABBV-368; Drug: ABBV-181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Terminal half-life (t1/2) of ABBV-368
Terminal half-life of ABBV-368
Measured: 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 (AUC) of ABBV-368
Area under the serum concentration-time curve of ABBV-368
Measured: 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
Maximum tolerated dose (MTD) of ABBV-368 when administered as monotherapy or in combination with ABBV-181
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.
Measured: Up to 1 year
Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181
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
Measured: Up to 18 months
Time to Cmax (Tmax) of ABBV-368
Time to Cmax of ABBV-368
Measured: 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 (β) of ABBV-368
Terminal phase elimination rate constant of ABBV-368
Measured: 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
Number of Participants With Adverse Events
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.
Measured: 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
Maximum observed serum concentration (Cmax) of ABBV-368
Maximum observed serum concentration of ABBV-368
Measured: 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
Secondary outcomes (4)
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
Measured: 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
Clinical benefit rate (CBR)
CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease.
Measured: 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
Duration of Objective Response (DOR)
DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measured: 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
Progression-Free Survival (PFS)
PFS time is defined as the time from the first dose of study drug (Day 1) to disease progression or death, whichever occurs first.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start21 Mar 2017
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071757
- Sponsor's protocol ID
- M16-074
- Other IDs
- 2016-004205-14, 2016
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2017
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 1, Open-Label, Dose-Escalation 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
- ClinicalTrials.gov ID
- NCT03071757
- Acronym / sponsor ID
- M16-074
- Conditions
- Advanced Solid Tumors Cancer
- Keywords
- Solid Tumors, Cancer, Metastatic Solid Tumors, Advanced Solid Tumors, Triple negative breast cancer (TNBC), Ovarian cancer, Hepatocellular carcinoma (HCC), Gastric cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer [TNBC] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Detailed description
Recruitment is closed in Part 1A; subjects are in maintenance
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Monotherapy Dose Escalation | Experimental | Drug: ABBV-368Part 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 Expansion | Experimental | Drug: ABBV-368Part 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 Expansion | Experimental | Drug: ABBV-368, Drug: ABBV-181Part 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 Participants | Experimental | Drug: ABBV-368, Drug: ABBV-181Part 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 Participants | Experimental | Drug: ABBV-368, Drug: ABBV-181Part 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must have histologic or cytology diagnosis of a known immunogenic solid tumor, as described for Part 1 Dose Escalation and Part 2 Cohort Expansion:
- Part 1 Dose Escalation:
- Participants with advanced or metastatic solid tumors that have exhausted standard treatment for their incurable disease and for whom there is currently no programmed cell death 1 (PD-1)/ programmed cell death-ligand 1 (PD-L1) approved therapy, with immunogenic type tumors such as, but not limited to triple negative breast cancer (TNBC), ovarian cancer, small cell lung cancer, mesothelioma, and cholangiocarcinoma.
- Participants who are refractory to a PD-1/PD-L1 agent, with tumor types such as melanoma, NSCLC, platinum-pretreated head and neck cancer, second line bladder and RCC.
- Part 2A and 2B Cohort Expansion:
Key exclusion criteria (6 listed)
- Received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 21 days prior to the first dose of ABBV-368.
- Prior treatment with an OX40 targeting agent.
- has known uncontrolled metastases to the central nervous system (CNS).
- History of active autoimmune disorders and other conditions that compromise or impair the immune system.
- Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active hepatitis A, B or C. Subjects who have a history of hepatitis B or C who have documented cures after anti-viral therapy may be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-368Intravenous infusion | Drug | Part 1A: Monotherapy Dose Escalation, Part 2A: Monotherapy Cohort Expansion, Part 2B: Combination Therapy Cohort Expansion, Part 3A: 18F-AraG Imaging Substudy in TNBC Participants, Part 3B: 18F-AraG Imaging Substudy in HNSCC Participants |
| ABBV-181Intravenous infusion | Drug | Part 2B: Combination Therapy Cohort Expansion, Part 3A: 18F-AraG Imaging Substudy in TNBC Participants, Part 3B: 18F-AraG Imaging Substudy in HNSCC Participants |
Primary outcome
Terminal half-life (t1/2) of ABBV-368
Time frame: 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 half-life of ABBV-368
Area under the serum concentration-time curve (AUC) of ABBV-368
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Maximum observed serum concentration (Cmax) of ABBV-368
Time frame: 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
Maximum observed serum concentration of ABBV-368
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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
Clinical benefit rate (CBR)
Time frame: 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
Duration of Objective Response (DOR)
Time frame: 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
Progression-Free Survival (PFS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-368 and ABBV-181 in people with Advanced Solid Tumors Cancer, run by AbbVie at 27 sites in 6 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 13 inclusion and 6 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: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, France, Taiwan, Japan and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Terminal half-life (t1/2) of ABBV-368 (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2022.