Pancreatic CancerPhase 2NCT07108504
Efficacy and Safety of LM-302 Combined With Gemcitabine CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Gemcitabine and LM-302 in people with Pancreatic Cancer and Chemotherapy Effect, run by Shanghai Zhongshan Hospital.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of LM-302 combined with gemcitabine as a second-line treatment for CLDN 18.2-positive unresectable locally advanced or metastatic pancreatic cancer. The main questions it aim to answer: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Chemotherapy Effect
- What is being tested?
- Gemcitabine and LM-302
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2025to 10 Aug 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
- Capable of providing written informed consent, understanding and complying with study requirements. Willing to participate after full disclosure of the study's purpose, procedures, potential risks, and benefits, and must sign the informed consent form before any study-related procedures.
- Age ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks before the first dose.
- Expected survival ≥3 months.
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) not amenable to curative treatment.
- Must have experienced disease progression or intolerance to first-line standard therapy containing 5-FU (fluorouracil) (radiologically confirmed).
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- At least one measurable lesion per RECIST v1.1.
- Must provide 5-7 unstained slides from archived (within 3 years) or fresh tumor tissue for CLDN18.2 and other biomarker testing. CLDN18.2 positivity defined as: Moderate-to-high staining intensity (2+~3+) in ≥50% of tumor cells, as assessed by central laboratory IHC (immunohistochemistry).
- Adequate Organ Function (within 7 days before first dose) Bone marrow function: Platelets (PLT) ≥90 × 10⁹/L; Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Hemoglobin ≥9 g/dL (no erythropoietin [EPO], G-CSF, or GM-CSF support within 14 days, and no transfusions within 7 days prior to treatment) Coagulation: INR ≤1.5; APTT ≤1.5 × ULN Liver function: Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome); AST/ALT ≤2.5 × ULN (≤5 × ULN if liver metastases present); Serum albumin (ALB) ≥28 g/L Renal function: Serum creatinine ≤1.5 × ULN; Creatinine clearance (CrCl) ≥50 mL/min (calculated by Cockcroft-Gault formula) Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF interval ≤470 ms
- Females of childbearing potential and males with fertile partners must agree to use highly effective contraception from 7 days before the first dose until 6 months after the last dose.
- Able to communicate effectively with investigators and comply with all study requirements.
Who cannot join
- Previous treatment with gemcitabine or nab-paclitaxel.
- Received any investigational drug or therapy within 28 days before the first dose of the study drug.
- Recent Anticancer Therapy (within 21 days before the first dose, except for): Palliative radiotherapy (e.g., for bone metastasis pain control) within 14 days. Oral drugs (e.g., fluoropyrimidines, small-molecule targeted agents) within 14 days or 5 half-lives (whichever is longer). Traditional Chinese medicine with anticancer indications within 14 days. Nitrosoureas or mitomycin C within 42 days. Therapeutic radiopharmaceuticals within 56 days.
- Residual Toxicities from Prior Therapy Adverse reactions from prior anticancer therapy have not recovered to CTCAE v5.0 Grade ≤1 (except for non-safety risks, such as alopecia, chronic radiotherapy toxicities ≤Grade 2, or lymphopenia).
- Poorly Controlled Tumor-Related Pain Patients requiring analgesics must be on a stable dose before study entry.
- Active or Untreated CNS Metastases Excludes those with previously treated, stable brain metastases (confirmed by imaging ≥4 weeks before the first dose, no new neurological symptoms, and no progression).
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- Proteinuria Urine protein ≥3+, or 2+ with 24-hour urine protein >1 g.
- Recent Life-Threatening Hemorrhage Any major bleeding event within 3 months before the first dose.
- High-Risk Esophageal/Gastric Varices Requires endoscopic evaluation within 3 months before the first dose if there is a history of variceal bleeding.
- Severe Liver Dysfunction Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B/C cirrhosis.
- Uncontrolled Third-Space Fluid Accumulation Clinically significant ascites/pleural effusion requiring repeated drainage, recent intervention (within 14 days), or causing complications (e.g., bowel obstruction).
- Tumor Invasion of Critical Structures Encasement of major vessels (aorta, SVC, etc.) or risk of fistula formation (e.g., tracheoesophageal, pleuroesophageal).
- History of GI Perforation/Fistula Within 6 months before the first dose.
- Bowel Obstruction/Perforation Risk Complete/incomplete intestinal obstruction or high perforation risk within 3 months before the first dose.
- Hypersensitivity to Antibody-Based Therapies History of ≥Grade 3 infusion reactions to monoclonal/bispecific antibodies, ≥Grade 3 immune-related AEs from prior immunotherapy, or discontinuation due to severe immune toxicity.
- Recent Systemic Corticosteroid Use ≥10 mg/day prednisone (or equivalent) for >7 days within 2 weeks before the first dose (topical/ocular/inhaled steroids allowed).
- Active Autoimmune Disease Includes but not limited to: Autoimmune hepatitis, SLE, rheumatoid arthritis, myasthenia gravis, multiple sclerosis. Exceptions: Stable hypothyroidism on hormone replacement, vitiligo, or psoriasis not requiring systemic therapy.
- Inflammatory Bowel Disease (IBD) Active or history of Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Interstitial Lung Disease (ILD) Current or prior ILD requiring systemic corticosteroids.
- Peripheral Neuropathy ≥Grade 2 sensory/motor neuropathy at screening.
- Allergy to MMAE-Based ADCs Known ≥Grade 3 hypersensitivity to antibody-drug conjugates containing monomethyl auristatin E (MMAE).
- Prior CLDN18.2-Targeted Therapy Any previous treatment targeting claudin 18.2 (CLDN18.2).
- Strong CYP3A4 Modifiers Use of strong inhibitors/inducers within 14 days before the first dose.
- Live Vaccination Received live/live-attenuated vaccines within 28 days (e.g., MMR, varicella, BCG, yellow fever). Allowed: Inactivated/mRNA COVID-19 vaccines, seasonal flu shots (non-nasal).
- Therapeutic Anticoagulation Current use of heparin/warfarin (except prophylactic low-dose therapy).
- Major Surgery/Trauma Undergone major surgery or invasive procedures within 28 days, or with unhealed wounds/fractures.
- Severe Cardiovascular Disease Includes: Uncontrolled arrhythmias (e.g., ventricular tachycardia, AV block ≥Grade 2). Thromboembolism requiring anticoagulation. NYHA Class III/IV heart failure. Acute coronary syndrome, stroke, or ≥Grade 3 CV events within 6 months. Uncontrolled hypertension.
- Active Infection Severe infections (e.g., sepsis, pneumonia) within 4 weeks, or ongoing systemic antibiotics within 2 weeks (except HBV/HCV antiviral therapy).
- Immunodeficiency History of primary/secondary immunodeficiency, organ transplant, or stem cell transplant (unless no immunosuppression needed).
- Chronic Viral Infections HIV-positive; Active HBV/HCV (exceptions): HBsAg+ if HBV DNA <500 IU/mL or undetectable; HCV Ab+ if HCV RNA negative.
- Active Tuberculosis (TB) Must be ruled out clinically if suspected.
- Other Malignancies Concurrent or history of other cancers within 5 years, except: Cured non-melanoma skin cancer, bladder CIS, low-risk prostate cancer (stage ≤T2a, Gleason ≤6, PSA ≤10 ng/mL), or cervical/breast CIS.
- Pregnancy/Lactation Positive pregnancy test within 7 days or breastfeeding.
- Psychiatric Disorders Conditions affecting compliance or safety judgment.
- Non-Cancer-Related Systemic Illness Severe comorbidities (e.g., leukemoid reaction (WBC >20×10⁹/L), cachexia (>15% weight loss in 3 months).
- Investigator's Discretion Any other condition deemed unsuitable for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of LM-302 Combined With Gemcitabine as Second-line Treatment for CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer
The goal of this clinical trial is to evaluate the efficacy and safety of LM-302 combined with gemcitabine as a second-line treatment for CLDN 18.2-positive unresectable locally advanced or metastatic pancreatic cancer.
The main questions it aim to answer:
Read more
- Does LM-302 plus gemcitabine improve the objective response rate (ORR, per RECIST 1.1) compared to historical controls?
- What is the safety and tolerability profile of this combination therapy?
Participants will receive:
- Gemcitabine (1000 mg/m² IV on Days 1, 8, and 15) in 4-week cycles, and LM-302 (1.8 mg/kg IV on Day 1) in 2-week cycles,
- Undergo regular tumor imaging (CT/MRI) and safety assessments;
- Provide blood samples for biomarker and pharmacokinetic analyses.
- Conditions
- Pancreatic Cancer, Chemotherapy Effect
- Being tested
- Gemcitabine, LM-302
- Keywords
- pancreatic adenocarcinoma, CLDN18.2, LM302, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine, 1000 mg/m², d1, 8, 15, q4 week
LM-302Drug
LM-302, 1.8 mg/kg, d1, q2 week
| Study group | Role | What they receive |
|---|---|---|
| LM-302 combined with Gemcitabine | Experimental | Not described Receives: Drug: Gemcitabine; Drug: LM-302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per RECIST 1.1
The proportion of participants with CLDN18.2-positive unresectable locally advanced or metastatic pancreatic adenocarcinoma achieving a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1 criteria.
Measured: From baseline until disease progression or study completion (up to 24 months).
Secondary outcomes (5)
Duration of Response (DOR) per RECIST 1.1
The time from first documented objective response (CR or PR) until disease progression or death, whichever occurs first, as assessed by RECIST 1.1.
Measured: From first response until progression/death (up to 24 months).
Disease Control Rate (DCR) per RECIST 1.1
The proportion of participants achieving CR, PR, or stable disease (SD) lasting ≥16 weeks, as assessed by RECIST 1.1.
Measured: From baseline until confirmed SD/response (up to 24 months).
Progression-Free Survival (PFS) per RECIST 1.1
Progression-Free Survival (PFS) is defined as the time from the first dose of study treatment (LM-302 + Gemcitabine) to the first occurrence of disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.
Measured: From first dose of study treatment until disease progression (per RECIST 1.1) or death from any cause, assessed up to 24 months.
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the first dose of study treatment (LM-302 + Gemcitabine) to death from any cause.
Measured: From first dose of study treatment until death from any cause or the end of follow-up, whichever occurs first, assessed up to 36 months.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Frequency and severity of adverse events (AEs), serious AEs (SAEs), and laboratory abnormalities graded by CTCAE v5.0.
Measured: From first dose until 30 days after last dose (up to 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108504
- Sponsor's protocol ID
- ZSPAC-16
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 7 Aug 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of LM-302 Combined With Gemcitabine as Second-line Treatment for CLDN 18.2 Positive Unresectable Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07108504
- Acronym / sponsor ID
- ZSPAC-16
- Conditions
- Pancreatic Cancer, Chemotherapy Effect
- Keywords
- pancreatic adenocarcinoma, CLDN18.2, LM302, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 7 Aug 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.
The goal of this clinical trial is to evaluate the efficacy and safety of LM-302 combined with gemcitabine as a second-line treatment for CLDN 18.2-positive unresectable locally advanced or metastatic pancreatic cancer.
The main questions it aim to answer:
- Does LM-302 plus gemcitabine improve the objective response rate (ORR, per RECIST 1.1) compared to historical controls?
- What is the safety and tolerability profile of this combination therapy?
Participants will receive:
- Gemcitabine (1000 mg/m² IV on Days 1, 8, and 15) in 4-week cycles, and LM-302 (1.8 mg/kg IV on Day 1) in 2-week cycles,
- Undergo regular tumor imaging (CT/MRI) and safety assessments;
- Provide blood samples for biomarker and pharmacokinetic analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LM-302 combined with Gemcitabine | Experimental | Drug: Gemcitabine, Drug: LM-302 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Capable of providing written informed consent, understanding and complying with study requirements. Willing to participate after full disclosure of the study's purpose, procedures, potential risks, and benefits, and must sign the informed consent form before any study-related procedures.
- Age ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks before the first dose.
- Expected survival ≥3 months.
- Histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) not amenable to curative treatment.
Key exclusion criteria (36 listed)
- Previous treatment with gemcitabine or nab-paclitaxel.
- Received any investigational drug or therapy within 28 days before the first dose of the study drug.
- Recent Anticancer Therapy (within 21 days before the first dose, except for): Palliative radiotherapy (e.g., for bone metastasis pain control) within 14 days. Oral drugs (e.g., fluoropyrimidines, small-molecule targeted agents) within 14 days or 5 half-lives (whichever is longer). Traditional Chinese medicine with anticancer indications within 14 days. Nitrosoureas or mitomycin C within 42 days. Therapeutic radiopharmaceuticals within 56 days.
- Residual Toxicities from Prior Therapy Adverse reactions from prior anticancer therapy have not recovered to CTCAE v5.0 Grade ≤1 (except for non-safety risks, such as alopecia, chronic radiotherapy toxicities ≤Grade 2, or lymphopenia).
- Poorly Controlled Tumor-Related Pain Patients requiring analgesics must be on a stable dose before study entry.
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 |
|---|---|---|
| GemcitabineGemcitabine, 1000 mg/m², d1, 8, 15, q4 week | Drug | LM-302 combined with Gemcitabine |
| LM-302LM-302, 1.8 mg/kg, d1, q2 week | Drug | LM-302 combined with Gemcitabine |
Primary outcome
Objective Response Rate (ORR) per RECIST 1.1
Time frame: From baseline until disease progression or study completion (up to 24 months).
The proportion of participants with CLDN18.2-positive unresectable locally advanced or metastatic pancreatic adenocarcinoma achieving a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1 criteria.
5 secondary outcomes
Duration of Response (DOR) per RECIST 1.1
Time frame: From first response until progression/death (up to 24 months).
Disease Control Rate (DCR) per RECIST 1.1
Time frame: From baseline until confirmed SD/response (up to 24 months).
Progression-Free Survival (PFS) per RECIST 1.1
Time frame: From first dose of study treatment until disease progression (per RECIST 1.1) or death from any cause, assessed up to 24 months.
Overall Survival (OS)
Time frame: From first dose of study treatment until death from any cause or the end of follow-up, whichever occurs first, assessed up to 36 months.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose until 30 days after last dose (up to 24 months).
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 7 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and LM-302 in people with Pancreatic Cancer and Chemotherapy Effect, run by Shanghai Zhongshan Hospital.
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 11 inclusion and 36 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 7 Aug 2025. 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?
Contact Wen-Quan Wang, Dr (+86 21 31587861, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) per RECIST 1.1 (time frame: From baseline until disease progression or study completion (up to 24 months).). 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 7 Aug 2025.