Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT06587425
The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing LM-302+Candonilimab+Capecitabine in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- LM-302+Candonilimab+Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2024to 31 Dec 2026
- 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
- The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin
- The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma
- Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at least 6 months after the last administration are eligible for inclusion. (Note: The treatment-related toxicity of oxaliplatin in previous adjuvant or neoadjuvant treatments must be restored to the National Cancer Institute [NCI] General Terminology Standard for Adverse Events [CTCAE] v5.0 Level 1 before enrollment)
- CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥ 10% is confirmed as positive, and\<10% is recorded as negative
- According to RECIST v1.1 standard, there should be at least one measurable lesion
- ECOG physical state ≤ 1
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- Expected lifespan\>3 months
- Adequate renal function: creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN) and glomerular filtration rate (GFR) ≥ 60mL/min/1.73 m2;
- Sufficient liver function: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN (if there is liver metastasis, AST and ALT ≤ 5 × ULN, total bilirubin ≤ 2.5 × ULN);
- Adequate bone marrow reserve: Platelet count (PLT) ≥ 100 × 109/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL (no adjuvant therapy such as EPO, G-CSF, or GM-CSF has been received within 14 days, and no blood transfusion including red blood cells and platelets has been received at least 7 days before the first administration); Prothrombin time/activated partial thromboplastin time (PT/PTT)\<1.5 x ULN;
- Male or female aged ≥ 18 years old.
Who cannot join
- Known HER2 positive gastric cancer/adenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires confirmation from ISH if the HER2 immunohistochemistry test result is 3+and the immunohistochemistry test result is 2+
- Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment;
- Active, known or suspected autoimmune diseases
- Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
- A cerebrovascular accident occurred within the past 6 months
- Clinically significant bleeding, bleeding events, or thromboembolic diseases occur within 6 months
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- History of intestinal perforation
- Have a history of (non infectious) pneumonia requiring steroid treatment or currently suffer from pneumonia
- Known history of human immunodeficiency virus (HIV) infection. Subjects with active hepatitis B or active hepatitis C. (Unless receiving antiviral therapy for at least 14 days prior to the first study drug administration and passing hepatitis B virus (HBV) DNA titer testing (not exceeding 500 IU/mL or 2500 copies [cps]/mL) and hepatitis C virus (HCV) RNA testing (not exceeding the lower limit of the assay), eligible for inclusion in the trial and willing to continue receiving effective antiviral therapy during the study period);
- Severe impairment of lung function or history of interstitial lung disease
- Diagnosed with concurrent malignant tumors within the past 2 years (except for fully treated non melanoma skin cancer, superficial bladder transitional cell carcinoma, and cervical carcinoma in situ [CIS]) or any currently active malignant tumor
- Previous or current evidence suggests that there may be confusion with the research results, interference with the participant\'s participation in the entire study process, any conditions, treatments, or laboratory abnormalities, or the researcher believes that participating in this study is not in the best interest of the participant
- Pregnancy test positive within 7 days before the first administration, or women of childbearing age who are in lactation period
- Individuals with known mental illnesses or disorders that may affect trial compliance
- Subjects who take systemic corticosteroids (\>10 mg daily prednisone equivalent) or other systemic immunosuppressive drugs (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 2 weeks prior to the first medication are allowed to use local, ocular, intra-articular, intranasal, and inhaled corticosteroids
- Subjects with a known history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, Guillain Barre syndrome, multiple sclerosis, or glomerulonephritis, excluding autoimmune hypothyroidism treated with stable dose hormone replacement therapy
- Individuals with a history of previous immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation The researcher determined that there are other situations that are not suitable for participation in this study
- The researcher determined that there are other situations that are not suitable for participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Yiyi Yu, Doctor, +86 21 6404 1990, yu.yiyi@zs-hospital.sh.cn
Tianshu Liu, Doctor
About this study
Official title: A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Read the detailed description
The antibody-drug conjugate (ADC) targeting CLDN18.2 exerts its anti-tumor effects through multiple mechanisms, including direct cytotoxicity to CLDN18.2-positive tumor cells via the delivery of a potent small-molecule toxin, a bystander effect that induces cytotoxicity in adjacent CLDN18.2-negative tumor cells, and the activation of the immune system through antibody-dependent cellular cytotoxicity (ADCC). The combination of this ADC with immune checkpoint inhibitors holds potential for synergistic anti-tumor activity. LM-302, an ADC specifically targeting CLDN18.2 and comprising a monoclonal antibody conjugated to MMAE, has demonstrated favorable efficacy and safety profiles in both preclinical and clinical studies for CLDN18.2-expressing gastrointestinal malignancies, including gastric and gastroesophageal junction adenocarcinomas. The combination of LM-302 with immune checkpoint inhibitors may offer enhanced clinical benefits for patients with advanced gastric cancer.
This clinical study aims to evaluate the efficacy and safety of LM-302 (ADC targeting Claudin18.2) in combination with cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4) and capecitabine as a first-line treatment in patients with unresectable, recurrent, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.
- Being tested
- LM-302+Candonilimab+Capecitabine
- Keywords
- CLDN18.2, ADC drug, cadonilimab, Immune Checkpoint Inhibitor, Targeted therapy, Immunotherapy, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-302+Candonilimab+CapecitabineDrug
Also called ADC-Claudin18.2+AK104+Capecitabine
LM-302: 1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m^2 po bid d1-10, q2w.
| Study group | Role | What they receive |
|---|---|---|
| LM-302+Cadonilimab+Capecitabine | Experimental | LM-302: 1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m^2 po bid d1-10, q2w. Receives: Drug: LM-302+Candonilimab+Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
Measured: Cycle 1 of each cohort. Duration of one cycle is 28 days
Progression Free Survival (PFS)
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
Measured: From enrollment until 6 months after the last participant discontinues treatment, up to approximately 42 months
Secondary outcomes (5)
Overall Survival (OS)
OS was defined defined as the time from date of randomization until death from any cause.
Measured: From enrollment until 6 months after the last participant discontinues treatment, up to approximately 42 months.
Objective response rate (ORR)
defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
Duration of response (DoR)
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
Disease control rate (DCR)
defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.
Measured: From start of treatment to date of documented disease progression, up to approximately 42 months
. AE and SAE
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0
Measured: : From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Jul 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies 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
- Model description
- The study is divided into a safety lead-in phase and an expansion phase. The safety lead-in phase will evaluate the dose-limiting toxicity (DLT) of the LM-302 combined with cadonilimab and capecitabine regimen in patients with unresectable, recurrent, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. Based on the safety data obtained from the lead-in phase, the expansion phase will determine the drug dosage and assess the efficacy and safety of the LM-302 combined with cadonilimab and capecitabine regimen in the same patient population.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
- Investigators
- Tianshu Liu, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587425
- Sponsor's protocol ID
- LM-302-IIT-203
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06587425
- Acronym / sponsor ID
- LM-302-IIT-203
- Keywords
- CLDN18.2, ADC drug, cadonilimab, Immune Checkpoint Inhibitor, Targeted therapy, Immunotherapy, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Detailed description
The antibody-drug conjugate (ADC) targeting CLDN18.2 exerts its anti-tumor effects through multiple mechanisms, including direct cytotoxicity to CLDN18.2-positive tumor cells via the delivery of a potent small-molecule toxin, a bystander effect that induces cytotoxicity in adjacent CLDN18.2-negative tumor cells, and the activation of the immune system through antibody-dependent cellular cytotoxicity (ADCC). The combination of this ADC with immune checkpoint inhibitors holds potential for synergistic anti-tumor activity. LM-302, an ADC specifically targeting CLDN18.2 and comprising a monoclonal antibody conjugated to MMAE, has demonstrated favorable efficacy and safety profiles in both preclinical and clinical studies for CLDN18.2-expressing gastrointestinal malignancies, including gastric and gastroesophageal junction adenocarcinomas. The combination of LM-302 with immune checkpoint inhibitors may offer enhanced clinical benefits for patients with advanced gastric cancer.
This clinical study aims to evaluate the efficacy and safety of LM-302 (ADC targeting Claudin18.2) in combination with cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4) and capecitabine as a first-line treatment in patients with unresectable, recurrent, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is divided into a safety lead-in phase and an expansion phase. The safety lead-in phase will evaluate the dose-limiting toxicity (DLT) of the LM-302 combined with cadonilimab and capecitabine regimen in patients with unresectable, recurrent, or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. Based on the safety data obtained from the lead-in phase, the expansion phase will determine the drug dosage and assess the efficacy and safety of the LM-302 combined with cadonilimab and capecitabine regimen in the same patient population.
| Arm | Type | Receives |
|---|---|---|
| LM-302+Cadonilimab+Capecitabine | Experimental | Drug: LM-302+Candonilimab+CapecitabineLM-302: 1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m^2 po bid d1-10, q2w. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin
- The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma
- Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at least 6 months after the last administration are eligible for inclusion. (Note: The treatment-related toxicity of oxaliplatin in previous adjuvant or neoadjuvant treatments must be restored to the National Cancer Institute [NCI] General Terminology Standard for Adverse Events [CTCAE] v5.0 Level 1 before enrollment)
- CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥ 10% is confirmed as positive, and\<10% is recorded as negative
- According to RECIST v1.1 standard, there should be at least one measurable lesion
Key exclusion criteria (18 listed)
- Known HER2 positive gastric cancer/adenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires confirmation from ISH if the HER2 immunohistochemistry test result is 3+and the immunohistochemistry test result is 2+
- Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment;
- Active, known or suspected autoimmune diseases
- Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
- A cerebrovascular accident occurred within the past 6 months
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 |
|---|---|---|
| LM-302+Candonilimab+CapecitabineAlso: ADC-Claudin18.2+AK104+CapecitabineLM-302: 1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m^2 po bid d1-10, q2w. | Drug | LM-302+Cadonilimab+Capecitabine |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Cycle 1 of each cohort. Duration of one cycle is 28 days
DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
Progression Free Survival (PFS)
Time frame: From enrollment until 6 months after the last participant discontinues treatment, up to approximately 42 months
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
5 secondary outcomes
Overall Survival (OS)
Time frame: From enrollment until 6 months after the last participant discontinues treatment, up to approximately 42 months.
Objective response rate (ORR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Duration of response (DoR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Disease control rate (DCR)
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
. AE and SAE
Time frame: : From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
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 19 Sep 2024.
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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.
Tianshu Liu, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LM-302+Candonilimab+Capecitabine in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site 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 11 inclusion and 18 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yiyi Yu, Doctor (+86 138 1673 0912, yu.yiyi@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Cycle 1 of each cohort. Duration of one cycle is 28 days). 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 19 Sep 2024.