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Digestive System Diseases

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Pancreatic Neoplasms

Adenocarcinoma

Pancreatic Cancer

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All Drugs and Chemicals

Paclitaxel

Gemcitabine

Albumin-Bound Paclitaxel

Y101D combined with Gemcitabine and Nab-Paclitaxel

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.

Y101D

Tao Zhang, MD

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.

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.

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

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

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

Objective Response Rate assessed according to RECIST 1.1 per investigator

The highest Y101D concentration in serum during one treatment cycle (21 days)

The lowest Y101D concentration in serum during one treatment cycle (21 days)

The area under the serum concentration versus tiem curve of Y101D during one treatment cycle (21 days)

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.

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.

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).

Disease control rate assessed according to RECIST 1.1 per investigator

The time from the first objective response to disease progression or death

The time from the first objective response to disease progression or death (Up to 12 months)

The time from the first objective response to death (Up to 2 yrs)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer	NCT06266143	Advanced Pancre...	Y101D	18 Years - 75 Years	Wuhan YZY Biopharma Co., Ltd.
A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer	NCT06266143	Advanced Pancre...	Y101D	18 Years - 75 Years	Wuhan YZY Biopharma Co., Ltd.

Spots Global Cancer Trial Database for y101d

Every month we try and update this database with for y101d cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for y101d

Every month we try and update this database with for y101d cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for y101d cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.