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

NCT04624217 | Completed Phase 1

• 1 other identifier: SHR-1701-II-204
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• RP2D

  Recommended Phase 2 Dose of SHR-1701

  Up to week 3

• ORR

  Objective Response Rate

  Up to approximately 6 months

Secondary Outcomes (6)

• Clinically significant toxicity

  Up to week 3

• OS rate

  From the start of treatment to 9 months

• AEs+SAEs

  from the first drug administration to within 90 days for the last SHR-1701 dose

• PFS

  Up to approximately 6 months

• DCR

  Up to approximately 12 months

Study Arms (1)

SHR-1701

EXPERIMENTAL

SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel

Drug: SHR-1701

Interventions

SHR-1701 DRUG

PDL1/TGFβ

Also known as: Gemcitabine and Albumin Paclitaxel

SHR-1701

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Beijing Cancer Hospital

Beijing, China

Location

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

SHR-1701; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

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: November 2, 2020
• First Posted: November 10, 2020
• Study Start: November 24, 2020
• Primary Completion: September 16, 2021
• Study Completion: February 8, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (2)