AzTrials
AzTrials

Advanced Pancreatic CancerPhase 1/2NCT05580445

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

A Phase 1/2 study testing CT-707, Toripalimab and Gemcitabine in people with Advanced Pancreatic Cancer, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
CT-707, Toripalimab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
11 Aug 2022to 11 Aug 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For inclusion in this study, patients must fulfil the following criteria:
  • Male or female (age of 18~75 years old).
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have a life expectancy of ≥ 3 months.
  • Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites.
  • 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.
Show all 13Show fewer
  • 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.
  • Coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; International Normalized ratio (INR) ≤ 1.5 times ULN.
  • Patients must have recovered from any acute adverse events (except alopecia and peripheral neurotoxicity ≤ Grade 2).
  • Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial; female participants must have a negative serum pregnancy test within 7 days prior to treatment.

Who cannot join

  • Patients must not enroll in this study if any of the following exclusion criteria are fulfilled:
  • 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.
  • Patients who have received clinical investigational drug or treatment within 4 weeks prior to the first use of the study drug.
  • Patients who have received major surgery within 4 weeks or had minor surgery within 2 weeks before the first dose of administration.
  • Patients who have previously received FAK inhibitor or programmed cell death protein 1/programmed cell death ligand 1 (PD-1/L1) antibody and cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody are not eligible.
  • 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 .
Show all 18Show fewer
  • 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.
  • Patients who have cardiovascular and cerebrovascular diseases currently or within the last 6 months, including but not limited to:
  • 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.
  • Patients suffering from conditions which are likely to adversely affect gastrointestinal motility (ulcerative disease, uncontrollable nausea, vomiting, diarrhea, or poor absorption syndrome).
  • 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).
  • Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage excluding those staying stable for at least two weeks after drainage.
  • Patients have active autoimmune disease that requires systemic treatment (immunomodulatory drugs, corticosteroids, or immunomodulatory drugs) in the past 2 years.
  • Patients with severely impaired lung functions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia and drug-associated pneumonia.
  • Patients have allergic reactions to any component of CT-707, toripalimab and gemcitabine, or with history of severe allergic reactions to other monoclonal antibodies or gemcitabine.
  • Female patients who are pregnant or breast-feeding, or male or female patients of reproductive potential who are not employing an effective method of birth control.
  • Patients with mental disorder, alcohol and/or drug dependence.
  • The investigator considers that the subject has a history of serious systemic diseases or other reasons and is not suitable or not willing to participate in this clinical study.

Trial locations and contacts

1 site in 1 country.

Yinghui Sun, PhD contact

86-10-88858616

yhsun@centaurusbio.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

    Xianjun Yu, PhD, 13801669875, yuxianjun@fudanpci.org

    Recruiting

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
CT-707, Toripalimab, Gemcitabine
Keywords
CT-707, Focal Adhesion Kinase, Advanced Pancreatic Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-707Drug

    Also called CT-707 granules

    Focal Adhesion Kinase (FAK) inhibitor

  • ToripalimabDrug

    Also called Toripalimab injection

    Programmed Death 1(PD-1) antibody

  • GemcitabineDrug

    Also called GEMZAR

    nucleoside inhibitor

Study groups in NCT05580445
Study groupRoleWhat they receive
Dose-escalation and dose-expansionExperimentalDose-escalation study is designed to determine the dose-limiting toxicity (DLTs) and recommended phase II dose (RP2D). Dose-expansion study is designed to evaluate the antitumor activity of CT-707 in combination with toripalimab and gemcitabine in patients with advanced pancreatic cancer.
Receives: Drug: CT-707; Drug: Toripalimab; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase 2 dose (RP2D) of CT-707 in combination with toripalimab and gemcitabine

    The RP2D will be determined from the maximum tolerated dose (MTD) found in the dose-escalation cohort. The MTD is determined as the dose at which no more than one patient (out of six) experiences any drug-related toxicity (DLT)

    Measured: Up to 24 months

Secondary outcomes (8)

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Characterization of the safety and tolerability as determined by changes in laboratory values and electrocardiograms

    Measured: Up to 24 months

  2. Pharmacokinetics (Cmax) for CT-707

    Defined as maximum observed plasma concentration

    Measured: Cycle 1 (each cycle is 21 days)

  3. Pharmacokinetics (Tmax) for CT-707

    Defined as time to maximum plasma concentration

    Measured: Cycle 1 (each cycle is 21 days)

  4. Pharmacokinetics (AUC0-t) for CT-707

    Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration

    Measured: Cycle 1 (each cycle is 21 days)

  5. Pharmacokinetics (t½) for CT-707

    Defined as the apparent plasma terminal phase disposition half-life

    Measured: Cycle 1 (each cycle is 21 days)

  6. Overall response rate (ORR) as assessed by RECIST 1.1 criteria

    Preliminary measure of anti-tumor activity of CT-707 in combination with toripalimab and gemcitabine

    Measured: Up to 24 months

  7. Progression free survival (PFS) according to RECIST v1.1 criteria

    Preliminary measure of anti-tumor activity of CT-707 in combination with toripalimab and gemcitabine

    Measured: Up to 24 months

  8. Disease control rate (DCR) according to RECIST v1.1

    Preliminary measure of anti-tumor activity of CT-707 in combination with toripalimab and gemcitabine

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start11 Aug 2022
  3. Primary completion11 Aug 2024 (estimated)
  4. Study completion11 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580445
Sponsor's protocol ID
CT-707-1
Status last verified
Nov 2023
First submitted
12 Oct 2022
Last updated
22 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CT-707, Toripalimab and Gemcitabine in people with Advanced Pancreatic Cancer, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yinghui Sun, PhD (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 dose (RP2D) of CT-707 in combination with toripalimab and gemcitabine (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in