A Trial of SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Pancreatic Cancer

A Phase Ib/II Trial of SHR-1701 Combined With Gemcitabine and Albumin Paclitaxel in First-line Treatment of Subjects With Advanced/Metastatic Pancreatic Cancer

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: SHR-1701

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects aged between 18 and 70 years;
• Life expectancy ≥ 12 weeks judged by the investigator.
• The ECOG performance status was 0-1.
• At least 1 measurable lesion conforming to RECIST 1.1 criteria.
• In subjects with histologically or cytologically confirmed pancreatic cancer, there was evidence of inoperable locally advanced or distant metastases.
• Adequate organ and bone marrow function.
• Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study.
• Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria:

• Known allergy to the study drug or any of its excipients; Or had a serious allergic reaction to other monoclonal antibodies.
• Previous exposure to drugs/antibodies acting on T cell co-stimulation or checkpoint pathways.
• Major surgery within 28 days before the first experimental treatment (biopsy required for diagnosis is permitted).
• Subject with central nervous system (CNS) metastases.
• Had other active malignant tumors within 5 years before entering the study. Except for basal cell or squamous cell carcinomas, superficial bladder carcinomas, carcinoma in situ of the cervix, ductal carcinoma in situ, and papillary carcinoma of the thyroid, which may be treated locally and have been cured.
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis.
• The presence of clinically significant acute or chronic pancreatitis.
• The presence of other acute or chronic infections of clinically significant significance.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701; SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel	Drug: SHR-1701; PDL1/TGFβ; Other Names: Gemcitabine and Albumin Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RP2D	Recommended Phase 2 Dose of SHR-1701	Up to week 3
ORR	Objective Response Rate	Up to approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant toxicity	above grade 3 AEs	Up to week 3
OS rate	9-month-overall survival rate	From the start of treatment to 9 months
AEs+SAEs	Adverse Events and Serious Adverse Events	from the first drug administration to within 90 days for the last SHR-1701 dose
PFS	Progression-Free-Survival	Up to approximately 6 months
DCR	Disease Control Rate	Up to approximately 12 months
OS	OS is the time interval from the start of treatment to death due to any reason or lost of follow-up	up to 2 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): September 16, 2021
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Gemcitabine
• Other Study ID Numbers: SHR-1701-II-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No