A Trial Of SHR-1701 In Combination With Gemcitabine And Albumin Paclitaxel In Patients With Pancreatic Cancer

Study Overview

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

N/A

Pancreatic Cancer

DRUG: SHR-1701

SHR-1701-II-204

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-10
First Submitted that Met QC Criteria 2020-11-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-11
First Posted (ACTUAL) 2020-11-10	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SHR-1701

SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel

DRUG: SHR-1701

PDL1/TGFβ

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record