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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer (NCT06770439) is a Phase 2 interventional studying Advanced Pancreatic Cancers, sponsored by Zhejiang University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a phase II study to evaluate the safety, tolerability and efficacy of IBI343 combined with chemotherapy in patients with advanced pancreatic cancer, including Part1 (safe lead-in phase) and Part2 (extension phase). In part1, patients with CLDN18.2-positive advanced pancreatic adenocarcinoma who had or had not previously received systemic therapy were treated with chemotherapy in IBI343 with AG regimen (albumin paclitaxel with gemcitabine). In part2, 40 patients with CLDN18.2-positive advanced PDAC will be enrolled, 1:1 randomized to Arm A and Arm B, respectively. In Arm A, patients will receive IBI343 TBD + gemcitabine TBD + albumin-bound paclitaxel TBD; and in Arm B, patients will receive gemcitabine 1000mg / m2 d1, d8 Q3W + albumin-bound paclitaxel 125mg / m2d1, d8 Q3W treatment.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Advanced Pancreatic Cancers and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Pancreatic Cancers subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed written willing to sign a consent form, willing and able to comply with the protocol specified visits and related procedures. - Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma. - Subjects must not be eligible for radical treatment such as radical radiotherapy and / or surgery; time to disease recurrence / metastasis\> 6 months for subjects with previous (new) adjuvant / adjuvant / radiotherapy) chemotherapy / radical chemoradiotherapy. In part 1: locally advanced or recurrent / metastatic stage with or without systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.). In part 2: The locally advanced or recurrent / metastasis phase has not received any systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.). - At least 1 measurable lesion (no previous radiotherapy) for solid tumors RECIST v1.1.(At baseline, computed tomography or magnetic resonance imaging showed the long diameter of 10 mm (except for lymph nodes, the short axis of the lymph node must be 15 mm), the diameter of the target lesion is 2 times the imaging layer thickness and the lesion is suitable for repeated accurate measurement. If a lesion located in the previously irradiated area clearly demonstrates a progression meeting the RECIST V1.1 criteria, the lesion acts as a measurable lesion). - Age was 18 years, and gender was unlimited. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) was 0 or 1. - The expected survival period was estimated at 12 weeks. - Sufficient bone marrow and organ function. - Female subjects of childbearing age or male partners of childbearing age should take effective contraception throughout the treatment period and within 6 months after the treatment period. - Pathological tissue testing was confirmed as CLDN18.2 positive. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Signed written informed consent, willing and able to comply with the protocol specified visits and related procedures. * Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma. * Subjects must not be eligible for radical treatment such as radical radiotherapy and / or surgery; time to disease recurrence / metastasis\> 6 months for subjects with previous (new) adjuvant / adjuvant / radiotherapy) chemotherapy / radical chemoradiotherapy. In part 1: locally advanced or recurrent / metastatic stage with or without systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.). In part 2: The locally advanced or recurrent / metastasis phase has not received any systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.). * At least 1 measurable lesion (no previous radiotherapy) for solid tumors RECIST v1.1.(At baseline, computed tomography or magnetic resonance imaging showed the long diameter of 10 mm (except for lymph nodes, the short axis of the lymph node must be 15 mm), the diameter of the target lesion is 2 times the imaging layer thickness and the lesion is suitable for repeated accurate measurement. If a lesion located in the previously irradiated area clearly demonstrates a progression meeting the RECIST V1.1 criteria, the lesion acts as a measurable lesion). * Age was 18 years, and gender was unlimited. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) was 0 or 1. * The expected survival period was estimated at 12 weeks. * Sufficient bone marrow and organ function. * Female subjects of childbearing age or male partners of childbearing age should take effective contraception throughout the treatment period and within 6 months after the treatment period. * Pathological tissue testing was confirmed as CLDN18.2 positive. Exclusion Criteria: * Is participating in another interventional clinical study, except for an observational (non-interventional) clinical study or is in the survival follow-up phase of the interventional study. * Treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the study drug. * The last anti-tumor therapy within 4 weeks before the first dose of the study drug or within 5 half-lives of the anti-tumor treatment (whichever is shorter) (2 weeks for washout with no exact half-life). * Received therapeutic or palliative radiotherapy within 2 weeks prior to the first administration of the study drug. * Receiving biliary stenting or PTCD within 7 days prior to the first use of study drug. * Other anti-tumor treatment is planned during the study medication \[allows palliative radiotherapy for the purpose of relieving symptoms (e. g. pain) and does not affect efficacy evaluation\]. * Any live vaccine is administered within 4 weeks before the first dose of the study drug or during the duration of the study. * A major surgical procedure (craniotomy, otomy, or tomy or otherwise defined by the investigator, excluding needle biopsy within 4 weeks before the first dose of study drug) or the presence of an unhealed wound, ulcer, or fracture; or a requirement that major surgery is planned during the study. For the purpose of palliative care, the local surgical treatment of isolated lesions is acceptable. Any live vaccine within 4 weeks before the first dose of the study drug or during the duration of the study. * A major surgical procedure (craniotomy, otomy, or tomy or otherwise defined by the investigator, excluding needle biopsy within 4 weeks before the first dose of study drug) or the presence of an unhealed wound, ulcer, or fracture; or a planned major surgery required during the study. For the purpose of palliative care, the local surgical treatment of isolated lesions is acceptable. * Failure to recover to grade 0 or 1 prior to the first dose of study drug of NCI CTCAE v5.0 (excluding alopecia, fatigue, pigmentation, and other conditions with no safety risk as judged by the investigator). * A history of gastrointestinal perforation and / or fistula within 6 months prior to the first dose of study drug was not resolved by surgery. presence of pyloric obstruction and / or persistent recurrent vomiting (3 times within 24 hours). * After gastrointestinal or tracheal lumen stenting. * Symptomatic CNS metastasis. For subjects with asymptomatic brain metastases (i. e., no glucocorticoid treatment, 1.5 cm treatment) or stable brain metastases after treatment, all the following criteria were required to participate in this study: no meson, pons, cerebellum, meninges, medullary or spinal cord metastasis; remained clinically stable for at least 4 weeks, confirmed clinical evidence of no new or expanded brain metastases, and stopped corticosteroid and anticonvulsant therapy for at least 2 weeks before the first dose of study drug. Note: The CNS is not used as a target lesion. * Bone metastases at risk of paraplegia. * Interstitial lung disease requiring steroid hormone therapy, or a history of - interstitial lung disease, non-infectious pneumonia, severely impaired or uncontrolled lung function, such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, or is suspected during screening. * There are diseases that fail to control History of the other primary malignancies. * A known medical history of immunodeficiency. * History of allogeneic organ transplantation and allogeneic HSCT. * Previous treatment with antibody drug conjugates based on topoisomerase inhibitors. * For medicated subjects, there was a previous history of allergy to the appropriate drug or preparation. * For subjects receiving medication, there are contraindications to the drug. * There was a history of prior drug-related non-morbidity. * Female subjects in pregnancy or lactation. * Other investigators are not eligible for participation in this study.

Treatments Being Tested

DRUG

IBI343

IBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate

DRUG

Gemcitabine+Albumin-bound paclitaxel

Gemcitabine+ Albumin-bound paclitaxel is one of the recommended first line regime for advanced pancreatic cancer

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06770439), the sponsor (Zhejiang University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06770439 clinical trial studying?

This study is a phase II study to evaluate the safety, tolerability and efficacy of IBI343 combined with chemotherapy in patients with advanced pancreatic cancer, including Part1 (safe lead-in phase) and Part2 (extension phase). In part1, patients with CLDN18.2-positive advanced pancreatic adenocarcinoma who had or had not previously received systemic therapy were treated with chemotherapy in IBI343 with AG regimen (albumin paclitaxel with gemcitabine). In part2, 40 patients with CLDN18.2-positive advanced PDAC will be enrolled, 1:1 randomized to Arm A and Arm B, respectively. In Arm A, patien… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06770439?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06770439?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06770439. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06770439. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.