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Pancreas CancerPhase 2NCT06255912

Clinical Trial for Advanced or Metastatic Pancreatic Cancer

A Phase 2 study testing LTC004 + MIL-97 and LTC004 + MIL-97+chemotherapy in people with Pancreas Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreas Cancer
What is being tested?
LTC004 + MIL-97 and LTC004 + MIL-97+chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Patients who sign the informed consent form
  • 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.
  • Diagnosed histologically or cytologically as pancreatic ductal adenocarcinoma
  • During screening, at least one measurable tumor lesion must be present (according to RECIST v1.1 criteria).
  • During screening, the Eastern Cooperative Oncology Group (ECOG) performance status should be ≤1.
  • During screening, an expected survival of ≥12 weeks is required, along with good organ function
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  • 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).
  • 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.
  • 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.

Who cannot join

  • Severe history of allergic reactions to other monoclonal antibodies or fusion protein medications.
  • Previous treatments including any immunotherapies such as immune checkpoint inhibitors, CD40, etc.
  • 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).
  • Uncontrolled pleural effusion, pericardial effusion, or ascites as determined by the investigator (requiring repeated drainage, multiple times per month, or more frequently).
  • 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).
  • 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.
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  • 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.
  • Having experienced grade ≥3 interstitial pneumonia during previous anticancer treatment.
  • 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
  • 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
  • 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)
  • 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
  • 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.
  • Patients who received systemic immunosuppressive therapy within 2 weeks before the first dose (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, or thalidomide);
  • 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.;
  • 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;
  • 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

About this study

Official title: 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 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.

Conditions
Pancreas Cancer
Being tested
LTC004 + MIL-97, LTC004 + MIL-97+chemotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • LTC004 + MIL-97Drug

    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

  • LTC004 + MIL-97+chemotherapyDrug

    LTC004 + MIL-97+chemotherapy

Study groups in NCT06255912
Study groupRoleWhat they receive
LTC004 + MIL-97ExperimentalNot described
Receives: Drug: LTC004 + MIL-97
LTC004 + MIL-97+ chemotherapyExperimentalNot described
Receives: Drug: LTC004 + MIL-97+chemotherapy

What is being measured

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

  1. Dose Limiting Toxicity

    safety

    Measured: within 3 weeks

  2. Maximum tolerated dose Tolerated Dose Dose

    Maximum tolerated dose

    Measured: during treatment（through study completion, an average of 1 year）

  3. Treatment Emergent Adverse Events

    safety

    Measured: during treatment（through study completion, an average of 1 year）

Secondary outcomes (1)

  1. overall response rate

    efficacy

    Measured: At the end of every 2 cycles(each cycle is 21 days）

Timeline

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

  1. First posted13 Feb 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Mar 2031 (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
Non-randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06255912
Sponsor's protocol ID
LTC004-201
Status last verified
Feb 2024
First submitted
26 Dec 2023
Last updated
23 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LTC004 + MIL-97 and LTC004 + MIL-97+chemotherapy in people with Pancreas Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 23 Feb 2024. 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?

This study is still under way. Results are not available in the source record yet.

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?

Dose Limiting Toxicity (time frame: within 3 weeks). The study lists 3 primary outcomes in all. 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 NCT06255912.

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 23 Feb 2024.

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