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

NCT06266143 | Active Not Recruiting Phase 1

• 1 other identifier: Y101D03
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicities (DLTs)

  Dose limiting toxicities during the first 21 days after the first administrations of Y101D in each cohort.

  From the time of the first dose (Day 1) until Day 21

• RP2D

  Recommended Phase 2 Dose of Y101D

  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

  From the time of first dosing (Day 1) until disease progression (up to 6 months)

Secondary Outcomes (10)

• Peak Serum Concentration (Cmax)

  From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).

• Trough Serum Concentration (Ctrough)

  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)

  From the time of first dosing (Day 1) until disease progression or toxicity intolerance (up to 6 months).

• The TGF-β concentration in serum

  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

  From the time of first dosing (Day 1) until disease progression or death or toxicity intolerance (up to 6 months).

Study Arms (1)

Experimental group

EXPERIMENTAL

Y101D combined with Gemcitabine and Nab-Paclitaxel

Drug: Y101D

Interventions

Y101D DRUG

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Wuhan YZY Biopharma Co., Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

Study Officials

• Tao Zhang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 20, 2024
• Study Start: February 8, 2023
• Primary Completion: March 21, 2025
• Study Completion: October 20, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)