Pancreatic CancerPhase 1NCT04807972
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis
A Phase 1 study testing ABBV-927, Budiglimab and modified FOLFIRINOX in people with Pancreatic Cancer, run by AbbVie at 15 sites in 6 countries.
Trial summary
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ABBV-927, Budiglimab and modified FOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 28 May 2021to 25 Mar 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight >= 35 kg.
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
- Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
- Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.
Who cannot join
- Participants with locally advanced disease.
- Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
- Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
- Prior radiotherapy to any measurable metastatic lesion at any time.
- Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
- Known metastases to the central nervous system (CNS).
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United States5 sites
UCHSC Anschultz Cancer Pavilion /ID# 227841
Aurora, Colorado, 80045-2517
Johns Hopkins Hospital /ID# 226713
Baltimore, Maryland, 21287
Univ Hosp Cleveland /ID# 226807
Cleveland, Ohio, 44106
Cleveland Clinic Main Campus /ID# 231135
Cleveland, Ohio, 44195
Penn State Hershey Medical Ctr /ID# 229837
Hershey, Pennsylvania, 17033-2360
Spain3 sites
Hospital Universitario Vall d'Hebron /ID# 230226
Barcelona, 08035
Hospital Universitario 12 de Octubre /ID# 230102
Madrid, 28041
Hospital Universitario Miguel Servet /ID# 230139
Zaragoza, 50009
Australia2 sites
Monash Medical Centre /ID# 231379
Clayton, Victoria, 3168
Austin Health /ID# 231378
Heidelberg, Victoria, 3084
Israel2 sites
Rambam Health Care Campus /ID# 229555
Haifa, H_efa, 3109601
The Chaim Sheba Medical Center /ID# 226812
Ramat Gan, Tel Aviv, 5265601
South Korea2 sites
Yonsei University Health System Severance Hospital /ID# 230280
Seoul, Seoul Teugbyeolsi, 03722
Asan Medical Center /ID# 230282
Seoul, Seoul Teugbyeolsi, 05505
Puerto Rico1 site
Pan American Center for Oncology Trials, LLC /ID# 228210
Rio Piedras, 00935
About this study
Official title: A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.
ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.
Read more
Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Read the detailed description
Study study was terminated before the Phase 2 portion of the study began.
- Conditions
- Pancreatic Cancer
- Being tested
- ABBV-927, Budiglimab, modified FOLFIRINOX
- Keywords
- Metastatic Pancreatic Cancer Disease, ABBV-927, Modified Folfirinox (mFFX), Budigalimab, ABBV-181, Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-927Drug
Intravenous (IV) Infusion
BudiglimabDrug
Also called ABBV-181
Intravenous (IV) Infusion
modified FOLFIRINOXDrug
Also called mFFX
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab. Receives: Drug: ABBV-927; Drug: Budiglimab; Drug: modified FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Percentage of participants experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
Measured: Up to 6 months
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.
Measured: Up to 6 months
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.
Measured: Up to 6 months
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication [e.g., COVID-19 vaccine] by the investigator or AbbVie Therapeutic Area (TA) MD] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.
Measured: Up to 6 months
Secondary outcomes (8)
Phase 1b: Maximum Plasma Concentration (Cmax)
The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Measured: Up to approximately 3 months
Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)
The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax.
Measured: Up to approximately 3 months
Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
Measured: Up to approximately 3 months.
Phase 1b: Objective Response Rate (ORR)
ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1.
Measured: Up to approximately 27 months
Phase 1b: Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response is either Complete Response (CR), Partial Response (PR), or stable disease (SD) according to RECIST version 1.1.
Measured: Up to approximately 27 months
Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
Measured: Up to approximately 27 months
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from randomization to a documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, clinical progression or death from any cause, whichever occurs earlier.
Measured: Up to approximately 24 months after study drug discontinuation
Phase 1b: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC)
Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) will measure participants' overall perceptions of their pancreatic cancer symptoms over time.
Measured: Up to approximately 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start28 May 2021
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT04807972
- Sponsor's protocol ID
- M20-732
- Other IDs
- 2020-005767-31
- Status last verified
- Jan 2025
- First submitted
- 17 Mar 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04807972
- Acronym / sponsor ID
- M20-732
- Conditions
- Pancreatic Cancer
- Keywords
- Metastatic Pancreatic Cancer Disease, ABBV-927, Modified Folfirinox (mFFX), Budigalimab, ABBV-181, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 May 2021 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 19 Mar 2021 (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.
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.
ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.
Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed description
Study study was terminated before the Phase 2 portion of the study began.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | Drug: ABBV-927, Drug: Budiglimab, Drug: modified FOLFIRINOXParticipants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body weight >= 35 kg.
- Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
- Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
- Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.
Key exclusion criteria (7 listed)
- Participants with locally advanced disease.
- Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
- Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
- Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
- Prior radiotherapy to any measurable metastatic lesion at any time.
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-927Intravenous (IV) Infusion | Drug | Phase 1b Dose Escalation |
| BudiglimabAlso: ABBV-181Intravenous (IV) Infusion | Drug | Phase 1b Dose Escalation |
| modified FOLFIRINOXAlso: mFFXIntravenous (IV) Infusion | Drug | Phase 1b Dose Escalation |
Primary outcome
Phase 1b: Percentage of participants experiencing Adverse Events
Time frame: Up to 6 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
Time frame: Up to 6 months
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.
Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
Time frame: Up to 6 months
Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.
Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
Time frame: Up to 6 months
A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication [e.g., COVID-19 vaccine] by the investigator or AbbVie Therapeutic Area (TA) MD] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.
8 secondary outcomes
Phase 1b: Maximum Plasma Concentration (Cmax)
Time frame: Up to approximately 3 months
Phase 1b: Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to approximately 3 months
Phase 1b: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
Time frame: Up to approximately 3 months.
Phase 1b: Objective Response Rate (ORR)
Time frame: Up to approximately 27 months
Phase 1b: Clinical Benefit Rate (CBR)
Time frame: Up to approximately 27 months
Phase 1b: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
Time frame: Up to approximately 27 months
Phase 1b: Progression Free Survival (PFS)
Time frame: Up to approximately 24 months after study drug discontinuation
Phase 1b: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC)
Time frame: Up to approximately 25 months
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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
15 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-927, Budiglimab and modified FOLFIRINOX in people with Pancreatic Cancer, run by AbbVie at 15 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Spain, Australia, Israel, South Korea 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 was stopped early (reason given: Strategic considerations). Results are not available in the source record.
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?
Phase 1b: Percentage of participants experiencing Adverse Events (time frame: Up to 6 months). The study lists 4 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 7 Jan 2025.