Pancreas CancerPhase 1/2FORTIFIDENCT06592664
Certepetide Phase 1b/2a Continuous Infusion Trial in mPDAC
A Phase 1/2 study testing certepetide, nab-paclitaxel and gemcitabine in people with Pancreas Cancer and Pancreatic Carcinoma, run by Lisata Therapeutics, Inc..
Trial summary
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma. The main questions it aims to answer are: is the new drug plus standard treatment safe and tolerable is the new drug plus standard treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatic Carcinoma, Pancreas Adenocarcinoma
- What is being tested?
- certepetide, nab-paclitaxel and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2030to Jan 2040
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been treated previously and be eligible for treatment with nab-paclitaxel and gemcitabine
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy ≥ 3 months
- At least one measurable tumor lesion as assessed by RECIST 1.1
- Adequate organ and marrow function
- Adequate contraception
Who cannot join
- Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents
- Received prior anti-cancer therapy for their pancreatic cancer
- Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results, including but not limited to:
- Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
- Active infection (viral, fungal, or bacterial) requiring systemic therapy
- Known active hepatitis B virus, hepatitis C virus, or HIV infection
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- Active tuberculosis as defined per local guidance
- History of allogeneic tissue/solid organ transplant
- Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- Pregnant or breastfeeding
- Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
- History or clinical evidence of symptomatic central nervous system (CNS) metastases
- Enrolled in any other clinical protocol or investigational trial
About this study
Official title: A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
- is the new drug plus standard treatment safe and tolerable
- is the new drug plus standard treatment more effective than standard treatment
Participants will:
- Visit the clinic three times every 28 days for treatment and tests
- Have CT or MRI scans every 8 weeks while on treatment
Read the detailed description
This is a Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study evaluating a single intravenous push of certepetide followed by a continuous infusion of certepetide over 4 hours when added to standard of care (SoC) versus two intravenous pushes of certepetide given 4 hours apart when added to SoC, versus SoC alone in people with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
The study will consist of a screening period, a run-in period, a treatment period, an end-of-treatment follow-up visit, and a long-term follow up period.
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period. Once eligibility is confirmed, participants will be randomized to one of the three treatment groups.
During the 3-day run-in period, participants will only receive the LSTA1 or placebo components of their randomized treatment regimen. After the 3-day run-in, Cycle 1 of treatment will commence. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.
- Conditions
- Pancreas Cancer, Pancreatic Carcinoma, Pancreas Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer
- Being tested
- certepetide, nab-paclitaxel, gemcitabine, placebo matching certepetide
- Keywords
- Chemo, Chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
certepetideDrug
Also called LSTA1, CEND-1
certepetide given as an IV push over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given
nab-paclitaxelDrug
Also called Abraxane
nab-paclitaxel 125 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days
gemcitabineDrug
gemcitabine 1000 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days
placebo matching certepetideDrug
placebo given as two IV pushes over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given
certepetideDrug
Also called LSTA1, CEND-1
certepetide given as two IV pushes over 1 minute when standard treatment(s) are given
placebo matching certepetideDrug
placebo given as an IV infusion over 4 hours when standard treatment(s) are given
placebo matching certepetideDrug
certepetide given as a slow IV push over 1 minute when standard treatment(s) are given
| Study group | Role | What they receive |
|---|---|---|
| SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion | Experimental | Not described Receives: Drug: certepetide; Drug: nab-paclitaxel; Drug: gemcitabine; Drug: placebo matching certepetide |
| SoC chemotherapy plus two certepetide IV pushes and placebo infusion | Experimental | Not described Receives: Drug: nab-paclitaxel; Drug: gemcitabine; Drug: certepetide; Drug: placebo matching certepetide |
| SoC chemotherapy plus two placebo IV pushes and placebo infusion | Active comparator | Not described Receives: Drug: nab-paclitaxel; Drug: gemcitabine; Drug: placebo matching certepetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
Measured: 30 days after treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startJan 2030 (estimated)
- Primary completionJan 2035 (estimated)
- Study completionJan 2040 (estimated)
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristen K. Buck, MD, Study chair, Lisata Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592664
- Sponsor's protocol ID
- LSTA1-P06
- Acronym
- FORTIFIDE
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2024
- Last updated
- 6 Jun 2025
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)
- ClinicalTrials.gov ID
- NCT06592664
- Acronym / sponsor ID
- FORTIFIDE / LSTA1-P06
- Conditions
- Pancreas Cancer, Pancreatic Carcinoma, Pancreas Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer
- Keywords
- Chemo, Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2030 (estimated)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
- is the new drug plus standard treatment safe and tolerable
- is the new drug plus standard treatment more effective than standard treatment
Participants will:
- Visit the clinic three times every 28 days for treatment and tests
- Have CT or MRI scans every 8 weeks while on treatment
Detailed description
This is a Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study evaluating a single intravenous push of certepetide followed by a continuous infusion of certepetide over 4 hours when added to standard of care (SoC) versus two intravenous pushes of certepetide given 4 hours apart when added to SoC, versus SoC alone in people with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
The study will consist of a screening period, a run-in period, a treatment period, an end-of-treatment follow-up visit, and a long-term follow up period.
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period. Once eligibility is confirmed, participants will be randomized to one of the three treatment groups.
During the 3-day run-in period, participants will only receive the LSTA1 or placebo components of their randomized treatment regimen. After the 3-day run-in, Cycle 1 of treatment will commence. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion | Experimental | Drug: certepetide, Drug: nab-paclitaxel, Drug: gemcitabine, Drug: placebo matching certepetide |
| SoC chemotherapy plus two certepetide IV pushes and placebo infusion | Experimental | Drug: nab-paclitaxel, Drug: gemcitabine, Drug: certepetide, Drug: placebo matching certepetide |
| SoC chemotherapy plus two placebo IV pushes and placebo infusion | Active comparator | Drug: nab-paclitaxel, Drug: gemcitabine, Drug: placebo matching certepetide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been treated previously and be eligible for treatment with nab-paclitaxel and gemcitabine
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy ≥ 3 months
- At least one measurable tumor lesion as assessed by RECIST 1.1
- Adequate organ and marrow function
Key exclusion criteria (13 listed)
- Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents
- Received prior anti-cancer therapy for their pancreatic cancer
- Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results, including but not limited to:
- History or clinical evidence of symptomatic central nervous system (CNS) metastases
- Enrolled in any other clinical protocol or investigational trial
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 |
|---|---|---|
| certepetideAlso: LSTA1, CEND-1certepetide given as an IV push over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given | Drug | SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion |
| nab-paclitaxelAlso: Abraxanenab-paclitaxel 125 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days | Drug | SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion, SoC chemotherapy plus two certepetide IV pushes and placebo infusion, SoC chemotherapy plus two placebo IV pushes and placebo infusion |
| gemcitabinegemcitabine 1000 mg/m^2 IV administered on Day 1, 8, and 15 every 28 days | Drug | SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion, SoC chemotherapy plus two certepetide IV pushes and placebo infusion, SoC chemotherapy plus two placebo IV pushes and placebo infusion |
| placebo matching certepetideplacebo given as two IV pushes over 1 minute and as an IV infusion over 4 hours when standard treatment(s) are given | Drug | SoC chemotherapy plus two placebo IV pushes and placebo infusion |
| certepetideAlso: LSTA1, CEND-1certepetide given as two IV pushes over 1 minute when standard treatment(s) are given | Drug | SoC chemotherapy plus two certepetide IV pushes and placebo infusion |
| placebo matching certepetideplacebo given as an IV infusion over 4 hours when standard treatment(s) are given | Drug | SoC chemotherapy plus two certepetide IV pushes and placebo infusion |
| placebo matching certepetidecertepetide given as a slow IV push over 1 minute when standard treatment(s) are given | Drug | SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion |
Primary outcome
Incidence of adverse events
Time frame: 30 days after treatment discontinuation
The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- 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.
Kristen K. Buck, MD study chair
Lisata Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing certepetide, nab-paclitaxel and gemcitabine in people with Pancreas Cancer and Pancreatic Carcinoma, run by Lisata Therapeutics, Inc..
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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Incidence of adverse events (time frame: 30 days after treatment discontinuation). 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 6 Jun 2025.