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Progression-free SurvivalPhase 2PaCNCT05958849

Advanced Pancreatic Cancer

A Phase 2 study testing Sovalteinib Solutumab Tegeo in people with Progression-free Survival, run by Zhejiang Cancer Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a single-arm, open, single-center clinical study to observe and evaluate the efficacy and safety of sovalteinib in combination with solutumab and tegeo in second-line and post-line treatment of patients with advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Progression-free Survival
What is being tested?
Sovalteinib Solutumab Tegeo
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Aug 2023to 30 Jul 2025
Phase
Phase 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

  • Subjects must meet all of the following conditions for enrollment:
  • subjects voluntarily enrolled in this study and signed an informed consent form, with good compliance and cooperation with follow-up;
  • patients with unresectable focally advanced or metastatic pancreatic cancer diagnosed by pathological histology or cytology
  • age between 18 and 75 years (both 18 and 75 years), male or female
  • ECOG score: 0-1; expected survival ≥ 12 weeks;
  • have progressed after receiving at least one prior systemic therapy for locally progressive or metastatic pancreatic cancer (including patients on first- or second-line regimens containing 5-FU)
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  • have at least one measurable lesion (according to RECIST 1.1 criteria); ≥ 10 mm in diameter as accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and at least 20 mm in diameter as determined by conventional CT scan
  • no serious organic diseases of the heart, lungs, brain and other organs;
  • essentially normal function of major organs and bone marrow:
  • routine blood (no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], no drug correction within 14 days prior to screening): leukocytes ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L, hemoglobin ≥ 90 g/L;
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT ) ≤ 1.5 x upper limit of normal (ULN);
  • liver function (no albumin transfusion within 14 days prior to screening): serum total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 3 x ULN, and serum total bilirubin ≤ 1.5 x ULN after internal/external drainage for obstructive jaundice;
  • Renal function: serum creatinine ≤ 1.5 x ULN, creatinine clearance (CCr) ≥ 50 mL/min;
  • normal cardiac function, two-dimensional cardiac ultrasound detection of left ventricular ejection fraction (LVEF ) ≥ 50%; New York Heart Association (NYHA) classification <3.
  • Male or female patients of childbearing potential voluntarily use an effective contraceptive method such as a double barrier method, condom, oral or injectable contraceptive medication, IUD, etc. during the study period and within 6 months of the last study dose. All female patients will be considered fertile unless the female patient is spontaneously menopausal, has undergone artificial menopause, or has been sterilized.

Who cannot join

  • participation in other antitumor drug clinical trials within 4 weeks prior to enrollment, including: interventional, chemotherapy, bioimmunotherapy, targeted therapy, etc;
  • previous treatment with a previous vascular endothelial growth factor (VEGFR) inhibitor or previous treatment with an immune checkpoint inhibitor, and previous treatment with tegeo;
  • other malignancies within the past 5 years, except for basal or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix
  • patients who have developed any brain metastases or are currently developing brain metastases
  • with liver metastases representing 50% or more of the total liver volume as determined by the investigator
  • have undergone any surgery (other than biopsy) or invasive treatment or operation within 4 weeks prior to enrollment and the surgical incision has not fully healed (except for intravenous placement, puncture drainage, internal/external drainage procedures for obstructive jaundice, etc.)
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  • have received local antitumor therapy such as hepatic artery interventional embolization, cryoablation of liver metastases or radiofrequency ablation within 4 weeks prior to enrollment;
  • clinically significant electrolyte abnormalities in the judgment of the investigator;
  • the patient has current hypertension that is not controlled by medication, specified as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg
  • urine routine suggestive of urine protein ≥ 2+ and 24-hour urine protein amount > 1.0 g
  • patients whose tumors are judged by the investigator to be at high risk of invading important blood vessels and causing fatal hemorrhage during the follow-up study;
  • patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months with vomiting, black feces, blood in stool), hemoptysis (>5 mL of fresh blood within 4 weeks); those with a history of hereditary or acquired bleeding disorders or coagulation disorders, who have had clinically significant bleeding symptoms within 3 months or have a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc;
  • clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class >2; ventricular arrhythmias requiring pharmacologic treatment; and electrocardiogram (ECG) showing QT c interval ≥480 ms;
  • active or uncontrolled serious infection (≥ CTCAE grade 2 infection);
  • unremitting toxic reactions above CTCAE grade 2 due to any prior anticancer therapy, excluding alopecia, lymphopenia and neurotoxicity ≤ grade 2 due to oxaliplatin;
  • women who are pregnant (positive pregnancy test prior to dosing) or breastfeeding
  • any other disease with a clinically significant metabolic abnormality, physical examination abnormality or laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is inappropriate for the use of the study drug (e.g., has seizures and requires treatment) or that would affect the interpretation of the study results or place the patient at high risk
  • known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded from active HBV infection, i.e., positive HBV DNA (>1×104 copies/mL or >2000 IU/ml); known hepatitis C virus infection (HCV) with HCV RNA positive (>1×103 copies/mL), or other hepatitis, cirrhosis];
  • persons with any active, known or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enterocolitis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitary inflammation, hyperthyroidism, etc.)
  • those who are allergic or suspected to be allergic to the study drug or similar drugs
  • Patients who, in the judgment of the investigator, have other factors that could affect the outcome of the study or force the termination of this study midway, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) requiring comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the safety of the patient.

About this study

Official title: A Single-arm, Open, Single-center Clinical Study of Sovalutinib in Combination With Solutumab and Tegeo in Second and Second Line for Advanced Pancreatic Cancer

This study is a single-arm, open, single-center clinical study to observe and evaluate the efficacy and safety of sovalteinib in combination with solutumab and tegeo in second-line and post-line treatment of patients with advanced pancreatic cancer.

A total of 30 patients were enrolled in this study, which was divided into 3 phases: screening phase, treatment phase and follow-up phase. During the treatment period, tumor status was evaluated by imaging methods every 6 weeks (±7 days) until disease progression (PD, RECIST 1.1) or death (during patient treatment) or intolerable toxicity, and tumor treatment and survival status after disease progression were recorded. Safety observations included AE, changes in laboratory test values, vital signs, and changes in ECG. In addition, 10 ml of blood was drawn for testing in our laboratory before each treatment and at the time of disease progression before the patients were enrolled, and the exploration of the efficacy-related biomarker BRCA1 was performed by blood samples.

Being tested
Sovalteinib Solutumab Tegeo

What participants receive

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

  • Sovalteinib Solutumab TegeoDrug

    Soventinib in combination with solutumab and tegeo for advanced pancreatic cancer

Study groups in NCT05958849
Study groupRoleWhat they receive
Prospective ResearchExperimentalSoventinib in combination with solutumab and tegeo dosing regimen: * Soventinib: 200 mg orally, within 1 hour of breakfast, administered once daily as a continuous dose, d1-d21, every 3 weeks in treatment cycles * Slulizumab: 300 mg administered intravenously, d1, every 3 weeks for one treatment cycle. * Tegeo: 40-60 mg/dose administered twice daily, d1-d14, continuously (dosing based on body surface area (BSA): 40 mg/dose for BSA ≤ 1.25 m2; 50 mg/dose for 1.25 ≤ BSA < 1.5 m2 and 60 mg/dose for BSA ≥ 1.5 m2), every 3 weeks for one treatment cycle. Dose adjustments, including suspension, dose reduction, or permanent discontinuation, were allowed as required by the protocol.
Receives: Drug: Sovalteinib Solutumab Tegeo

What is being measured

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

  1. PFS

    Time between the start of treatment and the onset of (any aspect of) progression of the tumor or death (from any cause)

    Measured: through disease progression, an average of 6 months

Secondary outcomes (3)

  1. ORR

    The proportion of patients whose tumor volume shrinks to a pre-specified value and who can maintain the minimum time requirement is the sum of the proportion in complete and partial remission.

    Measured: through disease progression, an average of 6 months

  2. DCR

    The number of cases that achieved remission (PR+CR) and stable lesions (SD) after treatment as a percentage of the evaluable cases.

    Measured: through disease progression, an average of 6 months

  3. OS

    Time from start of treatment to death (from any cause)

    Measured: through patients' death, an average of 12 months

Timeline

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

  1. First posted25 Jul 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion30 Jul 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05958849
Sponsor's protocol ID
IRB-2023-277
Acronym
PaC
Status last verified
Jul 2023
First submitted
8 Jun 2023
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sovalteinib Solutumab Tegeo in people with Progression-free Survival, run by Zhejiang Cancer Hospital.

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 15 inclusion and 21 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 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: through disease progression, an average of 6 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 NCT05958849.

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 25 Jul 2023.

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