Clinical Studies for the Treatment of Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2026-09-30

Brief Summary

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This trial is part of a multicenter, open-label Phase Ib/II clinical study evaluating the efficacy, safety, and tolerability of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors. Phase Ib of Cohort A1 determines the dose of LM-108 in combination with penpulimab + oxaliplatin + capecitabine. Phase II explores the efficacy and safety of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors.

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

LM-108 injection: Intravenous infusion, administered once on Day 1 of each treatment cycle, 21 days as a treatment cycle.

Penpulimab: Intravenous infusion, administered once on day 1 of each treatment cycle, 21 days as a treatment cycle.

Oxaliplatin: intravenous infusion over 2 hours once on day 1 of each treatment cycle, 21 days as a treatment cycle.

Capecitabine: Swallow with water within 30 minutes of meals. Dosing from day 1 to day 14, 2 times a day (1 time in the morning and 1 time in the evening; equal to the total daily dose of 2000 mg/m2); or 1 dose in the afternoon on day 1, 2 times a day from day 2 to day 14, and 1 dose in the morning on day 15. 21 days as a treatment cycle.

Tislelizumab+Oxaliplatin+Capecitabine

Group Type EXPERIMENTAL

LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

Intervention Type DRUG

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Tislelizumab+Oxaliplatin+Capecitabine

Tislelizumab: intravenous infusion once on day 1 of each treatment cycle,21 days as a treatment cycle.

Oxaliplatin: intravenous infusion over 2 hours once on day 1 of each treatment cycle, 21 days as a treatment cycle.

Capecitabine: Swallow with water within 30 minutes of meals. Dosing from day 1 to day 14, 2 times a day (1 time in the morning and 1 time in the evening; equal to the total daily dose of 2000 mg/m2); or 1 dose in the afternoon on day 1, 2 times a day from day 2 to day 14, and 1 dose in the morning on day 15. 21 days as a treatment cycle.

Group Type EXPERIMENTAL

Tislelizumab+Oxaliplatin+Capecitabine

Intervention Type DRUG

Tislelizumab is a humanized monoclonal antibody against Programmed cell death -Ligand-1(PD-1).

Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

LM-108 injection 10mg/kg +penpulimab

LM-108injection : Intravenous infusion, administered once on Day 1 of each treatment cycle, once every 3 weeks.

Penpulimab:Intravenous infusion,administered once on day 1 of each treatment cycle, once every 3 weeks.

Group Type EXPERIMENTAL

LM-108 injection 10mg/kg +penpulimab

Intervention Type DRUG

LM-108injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

LM-108 injection 600mg + penpulimab

LM-108injection : Intravenous infusion, administered once on Day 1 of each treatment cycle, 21 days as a treatment cycle.

Penpulimab:Intravenous infusion,administered once on day 1 of each treatment cycle, 21 days as a treatment cycle.

Group Type EXPERIMENTAL

LM-108 injection 600mg + penpulimab

Intervention Type DRUG

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Penpulimab+ Oxaliplatin+Capecitabine

Penpulimab: Intravenous infusion, administered once on day 1 of each treatment cycle, 21 days as a treatment cycle.

Oxaliplatin: intravenous infusion over 2 hours once on day 1 of each treatment cycle, 21 days as a treatment cycle.

Capecitabine: Swallow with water within 30 minutes of meals. Dosing from day 1 to day 14, 2 times a day (1 time in the morning and 1 time in the evening; equal to the total daily dose of 2000 mg/m2); or 1 dose in the afternoon on day 1, 2 times a day from day 2 to day 14, and 1 dose in the morning on day 15. 21 days as a treatment cycle.

Group Type EXPERIMENTAL

enpulimab+ Oxaliplatin+Capecitabine

Intervention Type DRUG

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Interventions

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LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Intervention Type DRUG

Tislelizumab+Oxaliplatin+Capecitabine

Tislelizumab is a humanized monoclonal antibody against Programmed cell death -Ligand-1(PD-1).

Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Intervention Type DRUG

LM-108 injection 10mg/kg +penpulimab

LM-108injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Intervention Type DRUG

LM-108 injection 600mg + penpulimab

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Intervention Type DRUG

enpulimab+ Oxaliplatin+Capecitabine

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Be at least 18 years old.
2. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1.
3. At least 1 measurable lesion as determined by RECIST v1.1 assessment. Positron emission tomography (PET) scans and ultrasonography cannot be used for diagnostic purposes.

Exclusion Criteria

5. Have adequate organ and bone marrow function, defined below:

1. Routine blood tests: (no transfusion, no granulocyte colony-stimulating factor (G-CSF), no drug correction) white blood cell count (WBC) ≥ 3,000/mm3 (3.0 × 109/L), neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L), platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L), hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L);
2. Biochemical tests: serum albumin ≥ 3.0 g/dL (30 g/L), serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (calculated using the Cockcroft-Gault formula), total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels ≤ 2.5 times the upper limit of normal (ULN), and patients with liver metastases should ≤ 5× ULN;
3. The international normalized ratio (INR) is ≤ 1.5, and the prothrombin time (PT) and activated partial thromboplastin time (APTT) are ≤ 1.5 times ULN;
4. Urine protein\< 2+; If the urine protein ≥ 2+, the 24-hour urine protein quantification shows that the protein must be ≤ 1 g;
5. Cardiac function: left ventricular ejection fraction ≥ 50% on echocardiography.
6. Expected survival ≥ 12 weeks;
7. Non-childbearing is defined as a woman who has reached a postmenopausal state, or who has had a medically documented bilateral oophorectomy. Male participants and female participants of childbearing potential must agree to use 1 medically approved form of contraception for the duration of the trial and for 6 months after the last dose of the trial drug or 9 months after the last dose of the chemotherapy drug (oxaliplatin), whichever is later, and a negative serum pregnancy test within 3 days prior to starting the study drug and not lactating.
8. With the consent of the person and has signed the informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests, and other trial procedures.

Enrollment criteria applicable to each cohort:

Cohorts A1 and A2 must meet the following enrollment criteria:
9. Patients with a pathologically confirmed diagnosis of Gastric cancer (GC) or Gastroesophageal junction cancer (GEJC), evidence of unresectable advanced or metastatic disease, and histologic confirmation of adenocarcinoma.
10. Provide negative reports of human epidermal growth factor receptor 2 (HER2) overexpression or amplification; HER2 overexpression or amplification negative is defined as Immunohistochemistry (IHC) 0/1+, or IHC 2+ with Fluorescence In Situ Hybridization (FISH)/In Situ Hybridization (ISH) negative.
11. No prior systemic therapy (including anti-HER-2 therapy) for advanced or metastatic GC/GEJC. Patients who have received prior adjuvant or neoadjuvant therapy for GC/GEJC (including: chemotherapy, radiotherapy, or chemoradiotherapy) have a time of first recurrence or disease progression greater than 6 months from the end of the last treatment. Participants who have previously received anti-tumor traditional Chinese medicine preparations are allowed, but must be discontinued at least 14 days prior to enrollment.
12. Participants should provide tumor tissue samples: fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue, or microneedle aspiration tissue collected at radiotherapy-naïve sites within approximately 24 months prior to enrollment (specimens within 6 months prior to the first dose of study drug are recommended and no systemic therapy has been received since the sample was obtained). For participants who are unable to provide tissue samples but meet other enrollment conditions, the investigator and the sponsor will jointly decide whether to enroll.

Cohorts A3 and A4 need to meet the following enrollment criteria:
13. Patients with pathologically confirmed solid tumors with evidence of advanced or metastatic unresectable disease.
14. Patients with advanced or metastatic solid tumors who have failed at least one prior line of standard therapy. Participants who have previously received anti-tumor traditional Chinese medicine preparations are allowed, but must be discontinued at least 14 days prior to enrollment.

1. Microsatellite Instability-High (MSI-H)/deficient Mismatch Repair (dMMR) is known.
2. Presence of uncontrolled or symptomatic active central nervous system metastases that can manifest as the presence of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. Central Nervous System (CNS) metastases may be enrolled in the study if they have been adequately treated (surgical or radiographed) and neurological symptoms have returned to baseline (except for residual signs or symptoms associated with CNS treatment) by at least 14 days prior to enrollment.
3. Pleural effusion and ascites that cannot be controlled after puncture and drainage and other treatments within 14 days prior to enrollment; Pericardial effusion with clinical symptoms or moderate or above.
4. Participant weight loss of more than 20% in 2 months prior to enrollment.
5. Participant weight loss of more than 20% in 2 months prior to enrollment:

1. Received Chemokine receptor 8 (CCR8) antibody, Cytotoxic T-lymphocyte-Associated Protein-4 (CTLA-4) antibody, or other drugs that act on Treg before enrollment.
2. Major surgery within 28 days prior to enrollment (tissue biopsy and peripherally venipuncture central venous catheter placement \[Peripherally Inserted Central Venous Catheters (PICC)\]/port implantation required for diagnosis are permitted).
3. Use of immunosuppressive medications, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacophysiological doses of other corticosteroids) within 14 days prior to enrollment.
4. Live attenuated vaccine within 28 days prior to enrollment or planned administration during the study and within 60 days after the end of study drug treatment.
5. Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days prior to enrollment.
6. Diagnosis of any other malignancy within 5 years prior to enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and has a clear medical record documented as cured, except for basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid gland.
7. Presence of any active, known or suspected autoimmune disease. Participants who are in a stable state and do not require systemic immunosuppressive therapy, such as: type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, and alopecia) are allowed.
8. Significant clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment; Arterial/venous thrombotic events occurred within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.
9. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to enrollment.
10. Severe, non-healing, or dehiscence wounds and active ulcers or untreated fractures.
11. Presence of grade \>1 peripheral neuropathy.
12. Gastrointestinal perforation and/or gastrointestinal fistula within 6 months prior to enrollment;
13. Previous intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to enrollment, including incomplete obstruction related to a pre-existing condition or requiring routine parenteral hydration, parenteral nutrition, or tube feeding: Patients may be allowed to be enrolled in the study if at the time of initial diagnosis if the patient has received definitive (surgical) treatment to resolve symptoms.
14. Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic disease (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, etc.).
15. Known hypersensitivity to the study drug or any of its excipients; or have had a severe allergic reaction to other monoclonal antibodies.
16. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as Hepatitis B Virus (HBV)-DNA ≥ 500 IU/ml; Hepatitis C, defined as Hepatitis C Virus (HCV)-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C.
17. Presence of cardiac clinical symptoms or disease that is not well controlled:

1. Cardiac insufficiency of grade 2 and above according to the New York Heart Association (NYHA) criteria.
2. Corrected QT Interval (QTc) \> 480 ms; The QTc interval was calculated using the Fridericia formula.
3. Severe/unstable angina.
4. Myocardial infarction occurred within 12 months prior to enrollment.
5. Clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure.
18. Systemic antibiotic use within 28 days prior to enrollment for ≥ 7 days, or unexplained fever \>38.5°C during screening/before the first dose (as judged by the investigator, fever due to tumor causes can be enrolled).
19. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
20. Participation in any other drug clinical study within 4 weeks prior to enrollment, or no more than 5 half-lives from the last study drug.
21. Known history of psychotropic substance abuse or drug abuse.
22. Presence of other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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