Metastatic Pancreatic CancerPhase 1NCT06199466
A Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer
A Phase 1 study testing Gemcitabine, Nab-paclitaxel and YL-13027 in people with Metastatic Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if the study drug, YL-13027, is safe to give in combination with gemcitabine and nab-paclitaxel to participants with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Gemcitabine, Nab-paclitaxel and YL-13027
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2024to 15 Sep 2025
- 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
- Age ≥18 years.
- Ability to understand and the willingness to sign a written informed consent document. 3. Ability to comply with the study protocol, in the investigator's judgment.
- 4. Participants with histologically confirmed metastatic pancreatic adenocarcinoma.
- 5. Refractory to one prior line of therapy in the metastatic setting. Participants are also eligible if they finished adjuvant/neoadjuvant therapy in the last 6 months and had disease recurrence.
- 6. Measurable disease with at least one lesion amenable to response assessment per the RECIST v1.1 (Appendix 2).
- 7. Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix 3).
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- 8. Adequate organ and marrow function as defined below :
- Hemoglobin ≥8.0 g/dL o Absolute neutrophil count ≥1500/mm3
- Platelets ≥100,000/mm3
- Total bilirubin ≤1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 × ULN
- AST/ALT ≤2.5 × institutional ULN or ≤5 × ULN for patients with liver metastases
- Measured or calculated creatinine clearance (CrCl; Cockcroft-Gault) ≥50 mL/min/1.73 m2. NOTE: For participants determined to be overweight or obese, actual body weight will be used to estimate CrCl.
- For participants not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen for at least 2 weeks before study entry.
- Albumin ≥ 3 g/dL. 9. Participants must have adequate washout from prior therapy at the time of study treatment initiation: ≥4 weeks from major surgery (excluding biopsy; NOTE: If a participant received major surgery, she/he must have recovered adequately from the toxicity and/or complications from the intervention prior to study treatment initiation); and ≥2 weeks or 5 half-lives (whichever is shorter) from prior therapy.
- 10. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the screening visit until 6 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Refer to Appendix 4 for contraception guidance.
- 11. Male participants of childbearing potential must agree to use a highly effective method of contraception and refrain from donating sperm from the screening visit until 3 months after the last dose of study treatment. Refer to Appendix 4 for contraception guidance.
- 12. WOCBP must have a negative serum pregnancy test result within 72 hours prior to study treatment initiation.
- 13. Participants with secondary malignancies are eligible if the malignancy does not have the potential to interfere with the safety or efficacy assessment of the study treatment. In addition, participants receiving hormonal therapy are eligible if the hormonal therapy does not interfere with the study treatment.
Who cannot join
- Prior therapy with a TGF-β pathway-targeted agent.
- Prior treatment with gemcitabine, nab-paclitaxel, or the combination of gemcitabine and nab-paclitaxel.
- Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy.
- Known symptomatic brain metastases or primary CNS malignancy. Participants who have stable symptoms and are requiring steroids of 4 mg/day dexamethasone equivalent or less for 2 weeks prior to enrollment are permitted.
- Live vaccines within 30 days prior to study treatment initiation.
- Human immunodeficiency virus (HIV) infection with a current history of acquired immunodeficiency syndrome-defining illness or HIV infection with CD4+ T cell count <350 cells/µL and HIV viral load more than 400 copies/µL.
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- Participants with active viral (any etiology) hepatitis are excluded. However, participants with serologic evidence of chronic hepatitis B virus (HBV) infection (positive hepatitis B surface antigen test and a positive hepatitis B core antibody test) who have a viral load below the limit quantification (HBV DNA titer <1000 cps/mL or 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the principal investigators (PIs) and IND Sponsor. The addition of HBV suppressive medication (i.e., entecavir) should be considered during the period of study treatment. Participants with a history of hepatitis C virus infection who have completed curative antiviral treatment and have a viral load below the limit of quantitation may be eligible and should be discussed with the PIs and Investigational New Drug (IND) Sponsor.
- Any of the following cardiac criteria experienced currently or within 6 months prior to enrollment: a. Congestive heart failure (New York Heart Association Functional Classification of ≥ Class 2) b. Acute coronary syndrome c. Clinically significant cardiac arrhythmia
- Mean QTcF >470 ms at screening.
- Left ventricular ejection fraction <50% or the lower limit of normal (per institutional standard) at screening.
- Use of strong CYP3A inhibitors or inducers are prohibited within 14 days or 5 halflives, whichever is longer, prior to study treatment initiation and during the study treatment. For a comprehensive list of CYP3A inhibitors/inducers, refer to: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-anddrug-interactions-table-substrates-inhibitors-and-inducers.
- Evidence of severe or uncontrolled systemic comorbidities (e.g., active bleeding diatheses or active infection), as determined by the investigator.
- Participants who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 3 months after the last dose of study treatment.
- Any condition that impairs a participant's ability to swallow whole pills or presence of active GI disease or other condition that will significantly interfere with the absorption, distribution, metabolism, or excretion of YL-13027, as determined by the investigator.
- Any known psychiatric, substance abuse, or other disorder that would interfere with cooperation with the requirements of the study, in the opinion of the investigator.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer
To learn if the study drug, YL-13027, is safe to give in combination with gemcitabine and nab-paclitaxel to participants with pancreatic cancer.
Read the detailed description
Primary Objectives
- To determine the safety and tolerability of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer.
- To determine the objective response rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer.
Secondary Objectives
- To evaluate other indicators of the antitumor activity of YL-13027 in combination with gemcitabine and nab-paclitaxel.
- To evaluate the PK of YL-13027 in combination with gemcitabine and nabpaclitaxel.
Exploratory Objectives
- To evaluate the PD effects of YL-13027 in combination with gemcitabine and nabpaclitaxel.
- To evaluate biomarkers of response and resistance to YL-13027 in combination with gemcitabine and nab-paclitaxel.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Gemcitabine, Nab-paclitaxel, YL-13027
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar®
Given by IV
Nab-paclitaxelDrug
Also called Paclitaxel, Abraxane, ABI-007
Given by IV
YL-13027Drug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Participants will be assigned to a dose level of YL-13027 in combination with gemcitabine and nab-paclitaxel based on when you join this study. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: YL-13027 |
| Dose Expansion | Experimental | Participants will receive YL-13027 in combination with gemcitabine and nab-paclitaxel at the recommended dose that was found in the Dose Escalation part. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: YL-13027 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and RP2D of YL-13027 in combination with gemcitabine and nab-paclitaxel.
Measured: Through study completion; an average of 1 year
Overall Response Rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel
As assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start22 Jan 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Why it stopped: \<75 % participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- 280Bio, Inc.
- Responsible party
- Sponsor
- Investigators
- Jordi Rodon Ahnert, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199466
- Sponsor's protocol ID
- 2023-0696
- Other IDs
- NCI-2023-11125
- Status last verified
- Nov 2025
- First submitted
- 29 Dec 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of YL-13027 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Refractory Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06199466
- Acronym / sponsor ID
- 2023-0696
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75 % participation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- 280Bio, Inc.
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 10 Jan 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.
To learn if the study drug, YL-13027, is safe to give in combination with gemcitabine and nab-paclitaxel to participants with pancreatic cancer.
Detailed description
Primary Objectives
- To determine the safety and tolerability of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer.
- To determine the objective response rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel in participants with refractory metastatic pancreatic cancer.
Secondary Objectives
- To evaluate other indicators of the antitumor activity of YL-13027 in combination with gemcitabine and nab-paclitaxel.
- To evaluate the PK of YL-13027 in combination with gemcitabine and nabpaclitaxel.
Exploratory Objectives
- To evaluate the PD effects of YL-13027 in combination with gemcitabine and nabpaclitaxel.
- To evaluate biomarkers of response and resistance to YL-13027 in combination with gemcitabine and nab-paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: YL-13027Participants will be assigned to a dose level of YL-13027 in combination with gemcitabine and nab-paclitaxel based on when you join this study. |
| Dose Expansion | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: YL-13027Participants will receive YL-13027 in combination with gemcitabine and nab-paclitaxel at the recommended dose that was found in the Dose Escalation part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥18 years.
- Ability to understand and the willingness to sign a written informed consent document. 3. Ability to comply with the study protocol, in the investigator's judgment.
- 4. Participants with histologically confirmed metastatic pancreatic adenocarcinoma.
- 5. Refractory to one prior line of therapy in the metastatic setting. Participants are also eligible if they finished adjuvant/neoadjuvant therapy in the last 6 months and had disease recurrence.
- 6. Measurable disease with at least one lesion amenable to response assessment per the RECIST v1.1 (Appendix 2).
Key exclusion criteria (17 listed)
- Prior therapy with a TGF-β pathway-targeted agent.
- Prior treatment with gemcitabine, nab-paclitaxel, or the combination of gemcitabine and nab-paclitaxel.
- Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy.
- Known symptomatic brain metastases or primary CNS malignancy. Participants who have stable symptoms and are requiring steroids of 4 mg/day dexamethasone equivalent or less for 2 weeks prior to enrollment are permitted.
- Live vaccines within 30 days prior to study treatment initiation.
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 |
|---|---|---|
| GemcitabineAlso: Gemcitabine Hydrochloride, Gemzar®Given by IV | Drug | Dose Escalation, Dose Expansion |
| Nab-paclitaxelAlso: Paclitaxel, Abraxane, ABI-007Given by IV | Drug | Dose Escalation, Dose Expansion |
| YL-13027Given by PO | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Maximum Tolerated Dose (MTD) and RP2D of YL-13027 in combination with gemcitabine and nab-paclitaxel.
Time frame: Through study completion; an average of 1 year
Overall Response Rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel
Time frame: Through study completion; an average of 1 year
As assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Results and safety
The study was stopped early (reason given: \<75 % participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Jordi Rodon Ahnert, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, Nab-paclitaxel and YL-13027 in people with Metastatic Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 18 inclusion and 17 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: \<75 % participation). 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?
Maximum Tolerated Dose (MTD) and RP2D of YL-13027 in combination with gemcitabine and nab-paclitaxel. (time frame: Through study completion; an average of 1 year). The study lists 2 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 8 Dec 2025.