Clinical Studies for the Treatment of Advanced Solid Tumors

December 10, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

An Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab + Chemotherapy in Patients With Advanced Solid Tumors - Cohort A

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Contact:
      • Hefei, Anhui, China, 230601230601
        • Not yet recruiting
        • The second hospital of Anhui medical university
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
      • Wuwei, Gansu, China, 733099
        • Not yet recruiting
        • Gansu Wuwei Tumour Hospital
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Not yet recruiting
        • Peking University Shenzhen Hospita
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Hebei
      • Tangshan, Hebei, China, 063001
        • Not yet recruiting
        • Tangshan People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Not yet recruiting
        • Harbin medical university cancer hospital
        • Contact:
    • Henan
      • Nanyang, Henan, China, 473012
        • Not yet recruiting
        • Nanyang Second General Hospital
        • Contact:
      • Pingdingshan, Henan, China, 467000
        • Recruiting
        • Ping mei shen ma Medical Group General Hospital
        • Contact:
          • liwei Gao, Master
          • Phone Number: 15937556165
          • Email: hnglw@126.com
        • Contact:
      • Zhengzhou, Henan, China, 450002
        • Not yet recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The second Xiangya hospital of central south university
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010000
        • Not yet recruiting
        • Inner Mongolia Hospital of Peking University Cancer Hospita
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • Not yet recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
          • Weiming Duan, Doctor
          • Phone Number: 13812681590
          • Email: wmduan@163.com
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University Medical College
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 264000
        • Not yet recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Not yet recruiting
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shangxi
      • Taiyuan, Shangxi, China, 030001
        • Not yet recruiting
        • First Hospital of Shangxi Medical University
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610042
        • Not yet recruiting
        • Sichuan Cancer Hospita
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830054
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Cancer Hospital
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325005
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  4. All acute toxicities due to prior antineoplastic therapy or surgery have resolved to Grade 0-1 (according to NCI-CTCAE v5.0) or to the level specified by the enrollment/exclusion criteria. Other toxicities that, in the opinion of the investigator, do not pose a safety risk to the participant, such as alopecia, fatigue, and hearing loss, are excluded.

  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.

Exclusion Criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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.
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of dose limiting toxicity (DLT) events
Time Frame: From first dose to 21days after first dose
Incidence of Phase Ib DLT events for Cohort A1.
From first dose to 21days after first dose
Progression-free survival (PFS)
Time Frame: The estimated time from randomization to patient disease progression was 10 months
Defined as the time from first dose to first occurrence of disease progression or death due to any cause.
The estimated time from randomization to patient disease progression was 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
After enrollment of all patients, the proportion of participants with the best overall efficacy rated as complete response or partial response according to criteria (RECIST1.1).
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
Duration of response (DOR)
Time Frame: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
Disease control rate (DCR)
Time Frame: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients.
The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient
Overall survival (OS)
Time Frame: From randomization until patient death, it is expected to be evaluated up to 5 years
The time from randomization to death due to any cause.
From randomization until patient death, it is expected to be evaluated up to 5 years
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline up to 90 days after the last dose
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Baseline up to 90 days after the last dose
AE/SAE severity
Time Frame: Baseline up to 90 days after the last dose
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Baseline up to 90 days after the last dose
Cmax
Time Frame: A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle

The highest blood concentration that occurs after administration.

A1, A2: cycle1,0 hour, 0 after LM-108, 4.5hours after penpulimab, 0 in 2, 4 and 6 cycles; 0 of cycle9 and every 4 cycles.

A3, A4: 0hour, instantly after LM-108, and after penpulimab, 1, 4, 24, 48, 168hours, and 336hours after penpulimab, 0 in 2, 4 and 6 cycles. Each cycle is 21 days.
A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
Tmax
Time Frame: A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
The time it takes to reach the peak concentration after dosing.
A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
T1/2
Time Frame: A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
The time it takes for the concentration of the drug to drop by half.
A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
Clearance rate (CL)
Time Frame: A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
The number of apparent volumes of distribution of the drug cleared from the body per unit of time.
A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
Apparent volume of distribution (Vz)
Time Frame: A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle

The ratio constant of the amount of drug in the body to the concentration of the drug in the blood when the drug reaches homeostasis in the body.

A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
A1/A2: 0hour in cycle 1, end of LM-108, 4.5hours post penpulimab; 0hour of 2,4,6cycles; 0hour of cycle 9 and every 4cycles. A3/A4: 0hour in cycle 1, end of LM-108, end of penpulimab, 1, 4, 24, 48, 168, 336hour; 0hour of 2, 4, 6cycles. 21 days as a cycle
Incidence of Immunogenicity indicators: anti-drug antibodies (ADA)
Time Frame: 0h on Day 1 of Cycles 1, 2, 4, and 6, 0 hours on Day 1 of Cycle 9 and every 4 cycles thereafter, end of treatment/early withdrawal follow-up, and Safety Follow-up Visit 1 (30 days after last dose). Each cycle is 21 days
Usually refers specifically to antidrug-binding antibodies.
0h on Day 1 of Cycles 1, 2, 4, and 6, 0 hours on Day 1 of Cycle 9 and every 4 cycles thereafter, end of treatment/early withdrawal follow-up, and Safety Follow-up Visit 1 (30 days after last dose). Each cycle is 21 days
Incidence of Immunogenicity indicators: neutralizing antibodies (Nab)
Time Frame: 0h on Day 1 of Cycles 1, 2, 4, and 6, 0 hours on Day 1 of Cycle 9 and every 4 cycles thereafter, end of treatment/early withdrawal follow-up, and Safety Follow-up Visit 1 (30 days after last dose). Each cycle is 21 days
Refers to anti-drug antibodies that interfere with the interaction of a drug with its target.
0h on Day 1 of Cycles 1, 2, 4, and 6, 0 hours on Day 1 of Cycle 9 and every 4 cycles thereafter, end of treatment/early withdrawal follow-up, and Safety Follow-up Visit 1 (30 days after last dose). Each cycle is 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 9, 2025

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM-108-Ib/II-01-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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