Pancreatic Cancer study: ANO31905
Official title ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT07444541
What this study is testing
What is ANO31905?
ANO31905 is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if ANO31905 combined with chemotherapy is safe and works for these patients.
- Who it's for
- Adults with CLDN18.2‑positive locally advanced unresectable or metastatic pancreatic cancer who have not been treated before.
- What's involved
- Participants will receive ANO31905 together with standard chemotherapy and will have regular doctor visits and tests to check safety and response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients voluntarily participate in the study and sign the written ICF;
- Males or females aged ≥ 18 at the time of signing the ICF;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival ≥ 3 months;
- Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous cell carcinoma) which is locally...
You likely can't join if
- Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment (except for in situ...
- Patients who have previously received an organ transplant/allogeneic bone marrow transplant or are awaiting an organ transplant/allogeneic bone...
- Patients who have received treatment with herbal medicines with well documented anti-tumor effects or indications within 14 days before the first...
- Patients who have participated in other treatment clinical trials and used treatment measures (such as drugs or devices) within 28 days before the...
- Patients who have undergone major organ surgery (excluding aspiration biopsy and venous catheterization) or experienced significant trauma within 28...
- Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines...
See the full eligibility criteria
- Patients voluntarily participate in the study and sign the written ICF;
- Males or females aged ≥ 18 at the time of signing the ICF;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival ≥ 3 months;
- Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous cell carcinoma) which is locally advanced unresectable or metastatic with the first diagnosis within 3...
- Those who have not received any anti-tumor treatment for locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma, including but not limited to surgery, radiotherapy, and chemotherapy
- At least one measurable lesion according to RECIST v1.1;
- Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory, defined as ≥1% of tumor cells with membranous staining intensity ≥1+ determined by IHC;
- Patients with sufficient organ function within 7 days before the first study dose;
- Non-pregnant or -lactating women; patients of childbearing potential (male and female) must agree to use a reliable method of contraception with their partner from the signing of the ICF until at least 3 months for...
- Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment (except for in situ cancer of the cervix, basal cell or squamous epithelial cell skin...
- Patients who have previously received an organ transplant/allogeneic bone marrow transplant or are awaiting an organ transplant/allogeneic bone marrow transplant during the expected study period;
- Patients who have received treatment with herbal medicines with well documented anti-tumor effects or indications within 14 days before the first study dose;
- Patients who have participated in other treatment clinical trials and used treatment measures (such as drugs or devices) within 28 days before the first study dose;
- Patients who have undergone major organ surgery (excluding aspiration biopsy and venous catheterization) or experienced significant trauma within 28 days before the first study dose;
- Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment;
- Patients with toxic reactions to previous anti-tumor therapy which haven't recovered to Grade ≤ 1 according to NCI-CTCAE v6.0 criteria (for CRS and ICANS, Grade ≤ 1 as per the ASTCT)),) excluding alopecia (any grade) or...
- Patients who have previously received treatment targeting CLDN18.2, including but not limited to monoclonal antibodies, bispecific antibodies, chimeric antigen receptor T-cell immunotherapy (CAR-T), or antibody-drug...
- Patients who have received corticosteroids for systemic use (\> 10 mg/day prednisone or equivalent) or other immunosuppressants (including but not limited to cyclophosphamide, methotrexate, and thalidomide) within 14...
- Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
- Patients who have previously experienced serious adverse reactions related to immunotherapy, or intolerance to immunotherapy;
- Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
- For Cohort B, use of strong inhibitors or inducers of CYP3A or use of strong inhibitors of UGT1A1.
- For Cohort B, known low or absent dihydropyrimidine dehydrogenase (DPD) activity. Where required by local regulations, testing for DPD deficiency must be performed using a validated method which is recommended by local...
- Patients with known metastases to the central nervous system;
- Patients with a poor nutrition condition of indicated by a weight ≤40 kg or body mass index (BMI) \<18.0 kg/m2
- Patients a with serious systemic infection or a medically unexplained fever ≥ 38.5°C (101.3°F) within 28 days before the first study dose;
- Patients with severe cardiovascular and cardiovascular diseases;
- Patients having severe advanced diseases with comorbidities that may be life-threatening in the short term;
- Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
- Patients with known or suspected interstitial pneumonitis, moderate to severe lung diseases that seriously affect respiratory function
- Patients with hepatitis B, hepatitis C, or a known HIV positive history or positive HIV screening;
- Patients with other conditions that may place the patients at increased undue study-related risks.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Plantation, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Plantation, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.