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UNKNOWNPHASE1/PHASE2

Safety, Pharmacokinetics and Efficacy of CT-707, Toripalimab and Gemcitabine in Advanced Pancreatic Cancer

A Phase Ib/II, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antineoplastic Activity of CT-707 in Combination With Toripalimab and Gemcitabine in Advanced Pancreatic Cancer

NCT05580445•Shouyao Holdings (Beijing) Co. LTD

View on ClinicalTrials.gov

Summary

This study will assess the safety, tolerability, pharmacokinetics and antineoplastic activity of CT-707 in combination with toripalimab and gemcitabine in patients with advanced pancreatic cancer

Detailed Description

This is a phase Ib/II, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and antineoplastic activity of CT-707 in combination with toripalimab and gemcitabine in patients with advanced pancreatic cancer.The study consists of two parts, dose-escalation part and dose-expansion part. Both parts will enroll patients with advanced pancreatic cancer. Dose-escalation study is designed to determine the dose-limiting toxicity (DLTs) and recommended phase II dose (RP2D), and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of CT-707 in combination with toripalimab and gemcitabine. Dose-expansion study phase is designed to evaluate the antitumor activity (objective response rate, progression-free survival, overall survival) of CT-707 in combination with toripalimab and gemcitabine in patients with advanced pancreatic cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For inclusion in this study, patients must fulfil the following criteria:
•1. Male or female (age of 18\~75 years old).
•2. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•3. Patients must have a life expectancy of ≥ 3 months.
•4. Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites.
•5. Patients are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral CT scan.
•6. Patients must have adequate organ and marrow function as defined below:
•Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; Platelet count (PLT) ≥ 100×10\^9/L; Hemoglobin (HGB) ≥ 90 g/L.
•Liver function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN), total bilirubin (TBIL) ≤ 1.5 times ULN in patients without liver metastases; AST and ALT ≤ 5 times ULN, TBIL ≤3 times ULN in patients with liver metastases.
•Renal function: Serum creatinine (Scr) ≤1.5 times ULN or creatinine clearance ≥60 mL/min/1.73 m2.
+3 more criteria

Exclusion Criteria

•1. Patients who have received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug.
•2. Patients who have received clinical investigational drug or treatment within 4 weeks prior to the first use of the study drug.
•3. Patients who have received major surgery within 4 weeks or had minor surgery within 2 weeks before the first dose of administration.
•5. Patients receiving any medications or substances that are known to be moderate to strong inhibitors or inducers of CYP3A4 and which cannot be discontinued at least 1 week prior to the first dose of administration .
•6. Patients who have active central nervous system (CNS)or leptomeningeal metastasis. However, participants who are asymptomatic, clinically stable, and did not require steroid therapy at least 4 weeks before the first dose of study treatment are eligible.
•7. Patients who have cardiovascular and cerebrovascular diseases currently or within the last 6 months, including but not limited to:
•I. Myocardial infarction; II. Unstable Angina pectoris; III. Cerebrovascular accident; IV. Other acute uncontrolled heart disease; Mean resting corrected QTc interval using the Fridericia formula (QTcF) \> 470 msec/female and \> 450 msec/male; Severe arrhythmias or abnormal cardiac conduction, such as ventricular arrhythmias requiring clinical intervention, degree ii-iii atrioventricular block, etc; Various factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of a first-degree relative with long QT syndrome or sudden unexplained death before the age of 40, receiving any medication with known QT prolongation; Left ventricular ejection fraction (LVEF) \< 40 % within 4 weeks prior to the first use of the study drug; Hypertension remains uncontrolled after aggressive antihypertensive therapy. Uncontrolled hypertension was defined as systolic blood pressure \> 185 mmHg and/or diastolic blood pressure \> 110 mmHg measured on 3 repetitions at least 10 minutes apart.
•8. Patients suffering from conditions which are likely to adversely affect gastrointestinal motility (ulcerative disease, uncontrollable nausea, vomiting, diarrhea, or poor absorption syndrome).
•9. Any evidence of severe or uncontrolled systemic disease, active infection or active bleeding diatheses, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
•10. Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage excluding those staying stable for at least two weeks after drainage.
+6 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

August 11, 2022

Primary Completion Date

August 11, 2024

Completion Date

August 11, 2024

Last Updated

November 22, 2023

Enrollment

114

ESTIMATED participants

Conditions

Advanced Pancreatic Cancer

Interventions

CT-707

DRUG

Toripalimab

DRUG

Gemcitabine

DRUG

Contacts

Yinghui Sun, PhD

CONTACT

86-10-88858616 yhsun@centaurusbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Pharmacokinetics and Efficacy of CT-707, Toripalimab and Gemcitabine in Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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