Advanced Pancreatic CancersPhase 2NCT06770439
IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
A Phase 2 study testing IBI343 and Gemcitabine+Albumin-bound paclitaxel in people with Advanced Pancreatic Cancers, run by Zhejiang University at 2 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancers
- What is being tested?
- IBI343 and Gemcitabine+Albumin-bound paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesChina
- Study dates
- 18 Apr 2025to Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 cannot join
- 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].
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, 310000
Yiwen Chen, MD, 86+15088682641, cherry0705@zju.edu.cn
- Recruiting
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yiwen Chen, 86+19941463683, yiwenchen0705@126.com
About this study
Official title: A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
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.
- Conditions
- Advanced Pancreatic Cancers
- Being tested
- IBI343, Gemcitabine+Albumin-bound paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI343Drug
IBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate
Gemcitabine+Albumin-bound paclitaxelDrug
Gemcitabine+ Albumin-bound paclitaxel is one of the recommended first line regime for advanced pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | In part1, patients with CLDN18.2-positive advanced pancreatic adenocarcinoma who had or had not previously received systemic therapy will be enrolled. The starting dose of the AG regimen was albumin-paclitaxel 100mg / m2 combined with gemcitabine 800mg / m2 by intravenous infusion (Intravenous, IV) D1 and D8 Q3W. If none of the first 3 subjects at 6 mg / kg had DLT during the DLT observation period, the combined high dose AG regimen was attempted. The investigator will adjust the dose of IBI343 combination chemotherapy according to the previous safety results and determine the safety of the combination dose, then entering the Part 2. Receives: Drug: IBI343; Drug: Gemcitabine+Albumin-bound paclitaxel |
| Part 2: Arm A | Experimental | 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. Receives: Drug: IBI343; Drug: Gemcitabine+Albumin-bound paclitaxel |
| Part 2: Arm B | Active comparator | 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 B, patients will receive gemcitabine 1000mg / m2 d1, d8 Q3W + albumin-bound paclitaxel 125mg / m2d1, d8 Q3W treatment. Receives: Drug: Gemcitabine+Albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study.
Measured: Up to 2 years
Adverse Event
Safety evaluation，such as hematotoxicity, hepatotoxicity, and renal function lab test, done continuously during treatment and the level of serum creatinine will be evaluated by using CTCAE 5.0 during study.
Measured: Up to 2 years.
Secondary outcomes (5)
Progression-free Survival
The time from enrolled to disease pregression or death from any cause during the whole study.
Measured: Up to 2 years.
Duration of Response
The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during the whole study.
Measured: Up to 2 years.
Disease Control Rate
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.
Measured: Up to 2 years.
Time to Response
The time from the first treatment to the first assessment of the tumor as CR or PR during the whole study.
Measured: Up to 2 years.
Overall Survival
The time from enrolled to death from any cause during the whole study.
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start18 Apr 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancersStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two parts in this study, 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 will be enrolled. The starting dose of the AG regimen was albumin-paclitaxel 100mg / m2 combined with gemcitabine 800mg / m2 by intravenous infusion (Intravenous, IV) D1 and D8 Q3W. If none of the first 3 subjects at 6 mg / kg had DLT during the DLT observation period, the combined high dose AG regimen was attempted. The investigator will adjust the dose of IBI343 combination chemotherapy according to the previous safety results and determine the safety of the combination dose, then entering the Part 2. 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 + AG regimen (TBD); and in Arm B, patients will receive AG regimen.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770439
- Sponsor's protocol ID
- CISPD-8
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06770439
- Acronym / sponsor ID
- CISPD-8
- Conditions
- Advanced Pancreatic Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are two parts in this study, 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 will be enrolled. The starting dose of the AG regimen was albumin-paclitaxel 100mg / m2 combined with gemcitabine 800mg / m2 by intravenous infusion (Intravenous, IV) D1 and D8 Q3W. If none of the first 3 subjects at 6 mg / kg had DLT during the DLT observation period, the combined high dose AG regimen was attempted. The investigator will adjust the dose of IBI343 combination chemotherapy according to the previous safety results and determine the safety of the combination dose, then entering the Part 2. 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 + AG regimen (TBD); and in Arm B, patients will receive AG regimen.
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: IBI343, Drug: Gemcitabine+Albumin-bound paclitaxelIn part1, patients with CLDN18.2-positive advanced pancreatic adenocarcinoma who had or had not previously received systemic therapy will be enrolled. The starting dose of the AG regimen was albumin-paclitaxel 100mg / m2 combined with gemcitabine 800mg / m2 by intravenous infusion (Intravenous, IV) D1 and D8 Q3W. If none of the first 3 subjects at 6 mg / kg had DLT during the DLT observation period, the combined high dose AG regimen was attempted. The investigator will adjust the dose of IBI343 combination chemotherapy according to the previous safety results and determine the safety of the combination dose, then entering the Part 2. |
| Part 2: Arm A | Experimental | Drug: IBI343, Drug: Gemcitabine+Albumin-bound paclitaxelIn 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. |
| Part 2: Arm B | Active comparator | Drug: Gemcitabine+Albumin-bound paclitaxelIn part2, 40 patients with CLDN18.2-positive advanced PDAC will be enrolled, 1:1 randomized to Arm A and Arm B, respectively. In Arm B, patients will receive gemcitabine 1000mg / m2 d1, d8 Q3W + albumin-bound paclitaxel 125mg / m2d1, d8 Q3W treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI343IBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate | Drug | Part 1, Part 2: Arm A |
| Gemcitabine+Albumin-bound paclitaxelGemcitabine+ Albumin-bound paclitaxel is one of the recommended first line regime for advanced pancreatic cancer | Drug | Part 1, Part 2: Arm A, Part 2: Arm B |
Primary outcome
Objective Response Rate
Time frame: Up to 2 years
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study.
Adverse Event
Time frame: Up to 2 years.
Safety evaluation，such as hematotoxicity, hepatotoxicity, and renal function lab test, done continuously during treatment and the level of serum creatinine will be evaluated by using CTCAE 5.0 during study.
5 secondary outcomes
Progression-free Survival
Time frame: Up to 2 years.
Duration of Response
Time frame: Up to 2 years.
Disease Control Rate
Time frame: Up to 2 years.
Time to Response
Time frame: Up to 2 years.
Overall Survival
Time frame: Up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI343 and Gemcitabine+Albumin-bound paclitaxel in people with Advanced Pancreatic Cancers, run by Zhejiang University at 2 sites in China.
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 10 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Tingbo Liang, MD. (86+19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.