Trial Title:
Clinical Trial for Advanced or Metastatic Pancreatic Cancer
NCT ID:
NCT06255912
Condition:
Pancreas Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
LTC004 + MIL-97
Description:
Dose group 1：MIL97:0.2mg/kg,Day1,Q3W,LTC004:90ug/kg,Day3,Q3W Dose group
2:MIL97:0.2mg/kg,Day1,Q3W,LTC004:180ug/kg,Day3,Q3W Dose group
-1:MIL97:0.2mg/kg,Day1,Q3W,LTC004:45ug/kg,Day3,Q3W
Arm group label:
LTC004 + MIL-97
Intervention type:
Drug
Intervention name:
LTC004 + MIL-97+chemotherapy
Description:
LTC004 + MIL-97+chemotherapy
Arm group label:
LTC004 + MIL-97+ chemotherapy
Summary:
This is a Phase II clinical trial assessing the safety, tolerability, and
pharmacokinetics of LTC004 in combination with MIL-97 ± chemotherapy in patients with
advanced or metastatic pancreatic cancer.
This experiment is divided into two parts: the dose increasing stage (stage 1) and the
dose expanding stage (stage 2). For those enrolled in the planned expansion phase, the
dose should have passed the safety assessment during the dose escalation phase.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who sign the informed consent form
2. Patients with inoperable advanced pancreatic cancer who have experienced progression
during or after receiving at least one systemic treatment line, including the
modified FOLFIRINOX regimen, capecitabine and/or gemcitabine, erlotinib, with or
without platinum agents (oxaliplatin, cisplatin, or carboplatin), or taxane agents
(paclitaxel, nab-paclitaxel, or docetaxel), etc.; patients with documented first
recurrence after adjuvant therapy can also be included in this study.
3. Diagnosed histologically or cytologically as pancreatic ductal adenocarcinoma
4. During screening, at least one measurable tumor lesion must be present (according to
RECIST v1.1 criteria).
5. During screening, the Eastern Cooperative Oncology Group (ECOG) performance status
should be ≤1.
6. During screening, an expected survival of ≥12 weeks is required, along with good
organ function
7. Before the initial administration of the investigational drug, systemic chemotherapy
should have been completed for at least 4 weeks, monoclonal antibody therapy for at
least 4 weeks, small molecule targeted therapy for at least 2 weeks, or for at least
5 half-lives of the drug (whichever is longer). Additionally, treatment with
domestically approved anti-tumor Chinese herbal medicine or traditional Chinese
medicine with anti-tumor effects should have been completed for at least 2 weeks
according to the National Medical Products Administration (NMPA).
8. Non-fertile female patients, or fertile female patients with a negative pregnancy
test result, who commit to using effective contraception or practicing abstinence
from the screening period until 6 months after the last dose of the investigational
drug (see Appendix V). Similarly, male patients commit to using effective
contraception or practicing abstinence from the screening period until 6 months
after the last dose of the investigational drug.
9. Understand and voluntarily sign the written Informed Consent Form (ICF), willing and
able to complete regular visits, follow the treatment plan, undergo laboratory
tests, and participate in other trial procedures.
Exclusion Criteria:
1. Severe history of allergic reactions to other monoclonal antibodies or fusion
protein medications.
2. Previous treatments including any immunotherapies such as immune checkpoint
inhibitors, CD40, etc.
3. Untreated, unstable, or uncontrolled central nervous system (CNS) metastases, except
for cases where: within at least 4 weeks before initial dosing, clinical MRI scans
demonstrate disease stability (at least 2 consecutive scans within 6 months before
enrollment, including one scan within 28 days before screening) and no progression
or uncontrolled neurological symptoms or signs (such as seizures, headaches, central
nausea, vomiting, progressive neurological deficits, papilledema).
4. Uncontrolled pleural effusion, pericardial effusion, or ascites as determined by the
investigator (requiring repeated drainage, multiple times per month, or more
frequently).
5. Patients with untreated or clinically symptomatic spinal cord compression that has
not been controlled (except for cases where patients have been treated and symptoms
have stabilized, imaging shows stability for at least 4 weeks before initial dosing,
without evidence of brain edema, and no need for corticosteroid treatment).
6. Having had ≥2 malignancies within 5 years before the initial dosing. Exceptions
include cured early-stage malignancies (carcinoma in situ or stage I tumors), such
as adequately treated cervical carcinoma in situ, thyroid cancer, basal cell or
squamous cell skin carcinoma.
7. Resting moderate to severe dyspnea due to advanced cancer or its complications,
severe primary lung diseases, current requirement for continuous oxygen therapy, or
clinically active interstitial lung disease (ILD) or pneumonia.
8. Having experienced grade ≥3 interstitial pneumonia during previous anticancer
treatment.
9. Individuals with active pulmonary tuberculosis infection within the year prior to
enrollment as identified by medical history or screening examinations, or those with
a history of active pulmonary tuberculosis infection more than one year ago but have
not received proper treatment
10. Severe infections within the first four weeks before the initial medication,
including but not limited to septicemia requiring hospitalization, severe pneumonia,
etc.; Active infections of CTCAE ≥2 grade requiring systemic antibiotic treatment
within two weeks before the initial medication
11. A history of severe cardiovascular diseases, including but not limited to severe
cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias
requiring clinical intervention, second or third-degree atrioventricular block,
etc.; Occurrence of acute coronary syndrome, congestive heart failure, aortic
dissection, stroke, or other grade 3 or above cardiovascular events within six
months before the initial medication; New York Heart Association (NYHA) functional
class II or left ventricular ejection fraction (LVEF) < or clinically uncontrolled
hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure
≥100mmHg)
12. During screening, patients with active hepatitis B (Hepatitis B virus titers > lower
limit of detection) or hepatitis C. Patients positive for Hepatitis B surface
antigen (HBsAg) or Hepatitis B core antibody (HBcAb) can participate in this study
if the Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test is below the upper
limit of normal detection at the respective research center. Patients positive for
Hepatitis C virus (HCV) antibodies can participate in this study if the HCV
ribonucleic acid (RNA) test is below the upper limit of normal detection at the
respective research center
13. Patients who test positive for syphilis during screening; Patients with active or
previously experienced and potentially relapsing autoimmune diseases (such as
systemic lupus erythematosus, rheumatoid arthritis, vasculitis), except for
clinically stable patients with autoimmune thyroid disease; Those with
immunodeficiency diseases or a history thereof, including positive serum testing for
human immunodeficiency virus (HIV); Individuals who have experienced significant
clinically relevant bleeding symptoms within 3 months before the first
administration.
14. Patients who received systemic immunosuppressive therapy within 2 weeks before the
first dose (including but not limited to glucocorticoids, cyclophosphamide,
azathioprine, methotrexate, or thalidomide);
15. Those who have used immune modulators within 2 weeks before the first dose (or 5
half-lives of the drug, whichever is longer), including but not limited to
thymopentin, IL-2, IL-15, interferons, etc.;
16. Patients who underwent curative radiotherapy within 4 weeks before the first dose,
and those who received palliative radiation within 14 days before the first dose;
17. Patients with tumors invading vital surrounding organs (such as the aorta and
trachea), or with a risk of esophageal or tracheal fistula, or esophageal pleural
fistula; 18. Individuals with a history of gastrointestinal perforation or fistula
within 6 months before the first dose;
19.Patients who received other investigational drugs or treatments not yet approved
within 4 weeks before the first dose.
20.Subjects who have received live attenuated vaccines or live vaccines within 4 weeks
before the first dose, or are expected to receive live attenuated vaccines or live
vaccines during the study period; 21.Individuals who underwent major surgery within 4
weeks before the first dose (excluding diagnostic procedures), are expected to undergo
major surgery during the study period (excluding diagnostic procedures), or have had
diagnostic or minimally invasive surgery within 7 days before the first dose (excluding
puncture biopsies); 22. Patients whose adverse reactions from previous anticancer therapy
have not recovered to Grade 1 according to CTCAE 5.0 (except for Grade 2 alopecia and
Grade 2 neuropathy caused by chemotherapy, Grade 2 hypothyroidism induced by anticancer
therapy, and Grade 2 reduction in hemoglobin); 23.Individuals who have previously
undergone allogeneic hematopoietic stem cell transplantation or solid organ
transplantation; 24.Pregnant or lactating women; 25.Subjects judged by the investigator
to have a history of other serious systemic diseases or any other reasons (such as mental
illness, alcoholism, substance abuse, or drug abuse) that may affect trial compliance and
make them unsuitable for participation in this study
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
March 1, 2024
Completion date:
March 1, 2031
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255912
