Advanced Pancreatic AdenocarcinomaPhase 1/2NCT06266143

A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer

A Phase 1/2 study testing Y101D in people with Advanced Pancreatic Adenocarcinoma, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Pancreatic Adenocarcinoma
What is being tested?: Y101D
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteChina
Study dates: 8 Feb 2023to 21 Jan 2025
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with pancreatic cancer (including ductal adenocarcinoma and acinar cell carcinoma) confirmed by histology or cytology; and evidence of unresectable or distant metastasis.
No prior systemic treatment for advanced/metastatic pancreatic cancer.
Previous use of anti-tumor Chinese herbal medicine or traditional Chinese medicine preparations, but discontinued use at least 28 days before the first administration of the investigational drug.
According to RECIST 1.1 criteria, the subject must have at least one measurable target lesion confirmed by CT or MRI examination that has not been locally treated (unless the target lesion has clearly progressed).
Expected survival time ≥ 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

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According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, any toxicity from previous anti-tumor treatment or surgery must have recovered to grade 0-1 or to the level specified by the inclusion/exclusion criteria. Note: Exclusions include alopecia, pigmentation changes, ≤ grade 2 neuropathy, hypothyroidism due to hormone replacement, or other adverse events confirmed to have become chronic.
Organ function levels must meet the following requirements:
Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelets (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90g/L (within 14 days before screening without blood transfusion, use of blood products, or correction with granulocyte colony-stimulating factor [G-CSF] or other hematopoietic growth factors).
Liver function: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the upper limit of normal (if there is liver metastasis, AST and ALT up to 5 times the upper limit of normal are allowed).
Renal function: Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal or creatinine clearance rate ≥ 50 mL/min (Cockcroft-Gault formula).
Coagulation function: International normalized ratio (INR) ≤ 1.5, prothrombin time (PT), and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal.

Who cannot join

Patients diagnosed with central nervous system (CNS) metastasis confirmed by imaging.
Patients with diseases associated with a high risk of clinically significant gastrointestinal bleeding (such as tumor invasion of the gastrointestinal tract or bile ducts) or any other condition or history related to severe bleeding.
Presence of clinically uncontrollable third-space fluid accumulation before the first administration of the investigational drug, such as pleural effusion, ascites, or pericardial effusion that cannot be controlled by drainage or other methods, as determined by the investigator.
Underwent major surgery within 4 weeks prior to the first administration of the investigational drug (excluding needle biopsies and tooth extractions).
Use of immunosuppressive drugs within 7 days prior to the first administration of the investigational drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroid hormones
Significant clinical pancreatitis.

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History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Presence of active clinical infection of grade 2 or higher (according to CTCAE v5.0 criteria) at screening, requiring systemic (oral or intravenous) antimicrobial treatment.
Patients requiring long-term use of steroids or immunosuppressive agents for conditions such as active autoimmune diseases or post-organ transplant maintenance therapy. Exceptions include type 1 diabetes, hypothyroidism that can be controlled by replacement therapy alone, and skin diseases (such as vitiligo, psoriasis, or alopecia) that do not require systemic treatment.
Severe respiratory system diseases or patients judged by the investigator to be unsuitable for inclusion, or patients with concomitant interstitial pneumonia.
Average corrected QT interval (QTcF) >450 msec (males) or >470 msec (females) based on three electrocardiogram (ECG) examinations during screening (repeat testing and averaging of three measurements are required only if the first ECG indicates QTcF >450 msec [males] or >470 msec [females]). History of long or short QT syndrome in the family or individual, or significant cardiovascular diseases within 6 months before screening.
History of non-study malignancy (excluding non-invasive lesions with extremely low risk of recurrence, such as squamous cell carcinoma and basal cell carcinoma of the skin, cervical carcinoma in situ, or breast carcinoma in situ) within 5 years prior to the first administration of the investigational drug.
Active hepatitis B (positive hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], peripheral blood HBV DNA titers <500 IU/mL allow inclusion), active hepatitis C, active syphilis, HIV-positive patients.
Pregnant or lactating women, or individuals with reproductive potential within 6 months after the end of this clinical study, regardless of gender.
Known history of substance abuse or drug addiction.
History of clear neurological or psychiatric disorders, as determined by the investigator, that would hinder compliance with treatment or adherence to instructions.

Trial locations and contacts

1 site in 1 country.

China1 site

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: Phase Ib/II Trial of Y101D Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Patients With Advanced Pancreatic Cancer

The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients.

Read the detailed description

A total of 57-81 systemic treatment-naïve patients with advanced pancreatic cancer will be enrolled in the study. Phase Ib will enroll 12-36 patients to assess the safety of Y101D combined with Gemcitabine and Albumin Paclitaxel at doses of 20mg/kg or 30mg/kg. The recommended phase 2 dose (RP2D) for Y101D in combination with the other drugs will be determined based on the safety profile and preliminary efficacy data.

Following determination of the RP2D, Phase II will enroll a total of 40-45 patients to evaluate the effectiveness of the combination treatment using the RP2D of Y101D. The primary endpoint of the Phase II study will be the objective response rate. Secondary endpoints will include progression-free survival (PFS), overall survival (OS), duration of response (DOR) and safety profiles. Pharmacodynamic parameters such as serum tumor biomarkers and TGF-β concentration will also be evaluated.

Overall, the study aims to assess the safety, efficacy, and pharmacodynamics of Y101D in combination with Gemcitabine and Albumin Paclitaxel as a first-line systemic treatment for advanced pancreatic cancer patients.

Conditions: Advanced Pancreatic Adenocarcinoma
Being tested: Y101D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Y101DDrug
Intravenous infusion of Y101D at day1, combined with Gemcitabine and Nab-Paclitaxel IV infusion at day1, 8, a 21-day cycle. After 6 cycles, Y101D and Gemcitabine infusion is applied as the maintenance treatment.

Study groups in NCT06266143
Study group	Role	What they receive
Experimental group	Experimental	Y101D combined with Gemcitabine and Nab-Paclitaxel Receives: Drug: Y101D

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicities (DLTs)
Dose limiting toxicities during the first 21 days after the first administrations of Y101D in each cohort.
Measured: From the time of the first dose (Day 1) until Day 21
RP2D
Recommended Phase 2 Dose of Y101D
Measured: From the enrollment of first patient through phae 1b study completion, an average of 1 year
Objective Response Rate (ORR)
Objective Response Rate assessed according to RECIST 1.1 per investigator
Measured: From the time of first dosing (Day 1) until disease progression (up to 6 months)

Secondary outcomes (10)

Peak Serum Concentration (Cmax)
The highest Y101D concentration in serum during one treatment cycle (21 days)
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Trough Serum Concentration (Ctrough)
The lowest Y101D concentration in serum during one treatment cycle (21 days)
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days)
The area under the serum concentration versus tiem curve of Y101D during one treatment cycle (21 days)
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
The TGF-β concentration in serum
The TGF-β concentreation in serum at 30 minutes before the first treatment dosing of Y101D and the subsequent dosing of Y101D every two cycles (Cycle 3 Day 1, Cycle 5 Day 1, etc.) until the disease progression or death or toxicity intolerance of Y101D.
Measured: From the time of first dosing (Day 1) until disease progression or death or toxicity intolerance (up to 6 months).
The CA19-9 concentration in serum
The CA19-9 concentreation in serum at 30 minutes before the first treatment dosing of Y101D and the subsequent dosing of Y101D every two cycles (Cycle 3 Day 1, Cycle 5 Day 1, etc.) until the disease progression or death or toxicity intolerance of Y101D.
Measured: From the time of first dosing (Day 1) until disease progression or death or toxicity intolerance (up to 6 months).
The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab)
The potivie rate of Anti-Drug Antibody and neutralizing antibody in serum 30 minutes before the Y101D infusion at Day 1 of Cycle 1, Cycle 2, Cycle 4 and Cycle 7 (a 21-day cycle).
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months)
Disease control rate (DCR)
Disease control rate assessed according to RECIST 1.1 per investigator
Measured: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Duration of response (DOR)
The time from the first objective response to disease progression or death
Measured: From the time of first dosing (Day 1) until one month after the EOT
Progression-free survival (PFS)
The time from the first objective response to disease progression or death (Up to 12 months)
Measured: From the time of first dosing (Day 1) until disease progression or death (up to 12 months).
Overall survival (OS)
The time from the first objective response to death (Up to 2 yrs)
Measured: From the time of first dosing (Day 1) until death (up to 2 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202321 Jan 2025

First posted20 Feb 2024
Study start8 Feb 2023
Primary completion21 Jan 2025
Study completion21 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Pancreatic AdenocarcinomaStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06266143
Sponsor's protocol ID: Y101D03
Status last verified: May 2026
First submitted: 24 Jan 2024
Last updated: 27 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Pancreatic Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ib/II Trial of Y101D Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Patients With Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT06266143
Acronym / sponsor ID: Y101D03
Conditions: Advanced Pancreatic Adenocarcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Wuhan YZY Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Feb 2023 (actual)
Primary completion: 21 Jan 2025 (actual)
Study completion: 21 Jan 2025 (actual)
First posted: 20 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental group	Experimental	Drug: Y101DY101D combined with Gemcitabine and Nab-Paclitaxel

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patients diagnosed with pancreatic cancer (including ductal adenocarcinoma and acinar cell carcinoma) confirmed by histology or cytology; and evidence of unresectable or distant metastasis.
No prior systemic treatment for advanced/metastatic pancreatic cancer.
Previous use of anti-tumor Chinese herbal medicine or traditional Chinese medicine preparations, but discontinued use at least 28 days before the first administration of the investigational drug.
According to RECIST 1.1 criteria, the subject must have at least one measurable target lesion confirmed by CT or MRI examination that has not been locally treated (unless the target lesion has clearly progressed).
Expected survival time ≥ 12 weeks.

Key exclusion criteria (16 listed)

Patients diagnosed with central nervous system (CNS) metastasis confirmed by imaging.
Patients with diseases associated with a high risk of clinically significant gastrointestinal bleeding (such as tumor invasion of the gastrointestinal tract or bile ducts) or any other condition or history related to severe bleeding.
Presence of clinically uncontrollable third-space fluid accumulation before the first administration of the investigational drug, such as pleural effusion, ascites, or pericardial effusion that cannot be controlled by drainage or other methods, as determined by the investigator.
Underwent major surgery within 4 weeks prior to the first administration of the investigational drug (excluding needle biopsies and tooth extractions).
Use of immunosuppressive drugs within 7 days prior to the first administration of the investigational drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroid hormones

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
Y101DIntravenous infusion of Y101D at day1, combined with Gemcitabine and Nab-Paclitaxel IV infusion at day1, 8, a 21-day cycle. After 6 cycles, Y101D and Gemcitabine infusion is applied as the maintenance treatment.	Drug	Experimental group

Primary outcome

Dose Limiting Toxicities (DLTs)
Time frame: From the time of the first dose (Day 1) until Day 21
Dose limiting toxicities during the first 21 days after the first administrations of Y101D in each cohort.
RP2D
Time frame: From the enrollment of first patient through phae 1b study completion, an average of 1 year
Recommended Phase 2 Dose of Y101D
Objective Response Rate (ORR)
Time frame: From the time of first dosing (Day 1) until disease progression (up to 6 months)
Objective Response Rate assessed according to RECIST 1.1 per investigator

10 secondary outcomes

Peak Serum Concentration (Cmax)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Trough Serum Concentration (Ctrough)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
The TGF-β concentration in serum
Time frame: From the time of first dosing (Day 1) until disease progression or death or toxicity intolerance (up to 6 months).
The CA19-9 concentration in serum
Time frame: From the time of first dosing (Day 1) until disease progression or death or toxicity intolerance (up to 6 months).
The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months)
Disease control rate (DCR)
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).
Duration of response (DOR)
Time frame: From the time of first dosing (Day 1) until one month after the EOT
Progression-free survival (PFS)
Time frame: From the time of first dosing (Day 1) until disease progression or death (up to 12 months).
Overall survival (OS)
Time frame: From the time of first dosing (Day 1) until death (up to 2 years).

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 27 May 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Pancreatic Adenocarcinoma

RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
RecruitingPhase 1/2
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
Pancreatic Ductal Adenocarcinoma (PDAC)

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.

Tao Zhang, MD principal investigator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Y101D in people with Advanced Pancreatic Adenocarcinoma, run by Wuhan YZY Biopharma Co., Ltd. at 1 site in China.

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 12 inclusion and 16 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 27 May 2026. 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 China. 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 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 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?

Dose Limiting Toxicities (DLTs) (time frame: From the time of the first dose (Day 1) until Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06266143.

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 27 May 2026.