AzTrials
AzTrials

Advanced Solid TumorPhase 1/2NCT06825494

Clinical Studies for the Treatment of Advanced Solid Tumors

A Phase 1/2 study testing LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine and LM-108 injection 10mg/kg +penpulimab in people with Advanced Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 32 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine and LM-108 injection 10mg/kg +penpulimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
32 sitesChina
Study dates
8 Apr 2025to Sep 2026
Phase
Phase 1/2
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

  • Be at least 18 years old.
  • The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1.
  • 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.
  • 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.
  • Have adequate organ and bone marrow function, defined below:
  • 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);
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  • 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;
  • The international normalized ratio (INR) is ≤ 1.5, and the prothrombin time (PT) and activated partial thromboplastin time (APTT) are ≤ 1.5 times ULN;
  • Urine protein< 2+; If the urine protein ≥ 2+, the 24-hour urine protein quantification shows that the protein must be ≤ 1 g;
  • Cardiac function: left ventricular ejection fraction ≥ 50% on echocardiography.
  • Expected survival ≥ 12 weeks;
  • 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.
  • 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:
  • 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.
  • 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.
  • 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.
  • 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:
  • Patients with pathologically confirmed solid tumors with evidence of advanced or metastatic unresectable disease.
  • 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.

Who cannot join

  • Microsatellite Instability-High (MSI-H)/deficient Mismatch Repair (dMMR) is known.
  • 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.
  • 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.
  • Participant weight loss of more than 20% in 2 months prior to enrollment.
  • Participant weight loss of more than 20% in 2 months prior to enrollment:
  • Received Chemokine receptor 8 (CCR8) antibody, Cytotoxic T-lymphocyte-Associated Protein-4 (CTLA-4) antibody, or other drugs that act on Treg before enrollment.
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  • 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).
  • 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.
  • 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.
  • Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days prior to enrollment.
  • 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.
  • 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.
  • 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.
  • Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to enrollment.
  • Severe, non-healing, or dehiscence wounds and active ulcers or untreated fractures.
  • Presence of grade >1 peripheral neuropathy.
  • Gastrointestinal perforation and/or gastrointestinal fistula within 6 months prior to enrollment;
  • 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.
  • Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic disease (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, etc.).
  • Known hypersensitivity to the study drug or any of its excipients; or have had a severe allergic reaction to other monoclonal antibodies.
  • 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.
  • Presence of cardiac clinical symptoms or disease that is not well controlled:
  • Cardiac insufficiency of grade 2 and above according to the New York Heart Association (NYHA) criteria.
  • Corrected QT Interval (QTc) > 480 ms; The QTc interval was calculated using the Fridericia formula.
  • Severe/unstable angina.
  • Myocardial infarction occurred within 12 months prior to enrollment.
  • Clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure.
  • 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).
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • 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.
  • Known history of psychotropic substance abuse or drug abuse.
  • 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.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Shen, Doctor contact

010-88196561

doctorshenlin@sina.cn

32 sites in 1 country

China32 sites, 32 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, Doctor, 010-88196561, doctorshenlin@sina.cn

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000

    Ying Liu, Doctor, 13756002505, yingliu700930@foxmail.com

    Not yet recruiting

  • The second xiangya hospital of central south university

    Changsha, Hunan, 410011

    Yawen Gao, Doctor, 18673194799, 2948390593@qq.com

    Not yet recruiting

  • Sichuan Cancer Hospita

    Chengdu, Sichuan, 610042

    Ping Zhao, Doctor, 18908190029, scszlyywabqzp@163.com

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Rongbo Lin, Bachelor, 13705919382, rongbo_lin@163.com

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150040

    Zhiwei Li, Doctor, 15004683651, lzhw0451@163.com

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

    Yueyin Pan, Doctor, 13805695536, yueyinpan1965@126.com

    Not yet recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601230601

    Mingjun Zhang, Doctor, 13865952007, 754386488@qq.com

    Not yet recruiting

  • Inner Mongolia Hospital of Peking University Cancer Hospita

    Hohhot, Inner Mongolia, 010000

    Xiaotian Zhang, Doctor, 13810995536, zhangxiaotianmed@163.com

    Not yet recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 264000

    Bo Liu, Master, 15553115688, lb20201110@163.com

    Not yet recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730030

    XiaoMing Hou, Doctor, 136 0936 6285, 1795950415@qq.com

    Not yet recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210000

    Xiaofeng Chen, Doctor, 13585172066, Xiaofengch198019@126.com

    Not yet recruiting

  • NanJing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

    Jia Wei, Doctor, 13951785234, jiawei99@nju.edu.cn

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

    Yongqiang Li, Master, 13457161928, lyq702702@126.com

    Not yet recruiting

  • Nanyang Second General Hospital

    Nanyang, Henan, 473012

    Yuan Liu, Master, 13937732728, liuyuan2003@163.com

    Not yet recruiting

  • Ping mei shen ma Medical Group General Hospital

    Pingdingshan, Henan, 467000

    liwei Gao, Master, 15937556165, hnglw@126.com

    Jiarong Liu, Master, 13525396563, liujrong006@163.com

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhe Zhang, Doctor, 18121299381, zhangzhe2010fduscc@gmail.com

    Not yet recruiting

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200120

    Xiuying Xiao, Doctor, 13564579313, xiaoxiuying2002@163.com

    Not yet recruiting

  • The First Hospital Of China Medical University

    Shenyang, Liaoning, 110000

    Xiujuan Qu, Doctor, 13604031355, qu_xiujuan@hotmail.com

    Not yet recruiting

  • Peking University Shenzhen Hospita

    Shenzhen, Guangdong, 518000

    Shubin Wang, Doctor, 13823394076, Wangshubin2013@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Weiming Duan, Doctor, 13812681590, wmduan@163.com

    Not yet recruiting

  • First Hospital of Shangxi Medical University

    Taiyuan, Shangxi, 030001

    Yusheng Wang, Doctor, 13834646436, wangyusheng1972@163.com

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Mudan Yang, Master, 13803433331, yangmd6000@163.com

    Not yet recruiting

  • Tangshan People's Hospital

    Tangshan, Hebei, 063001

    Zhiwu Wang, Doctor, 18931506162, tcm2000@163.com

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

    Ting Deng, Doctor, 15802243063, xymcdengting@126.com

    Not yet recruiting

  • Xinjiang Medical University Affiliated Cancer Hospital

    Ürümqi, Xinjiang, 830054

    Yong Tang, Master, 13899880718, ae717ty@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325005

    Wenfeng Li, Master, 13968840592, lwf@hosp1.ac.cn

    Jun Cheng, Master, 13600668439, 1043475708@qq.com

    Not yet recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Huiting Xu, Doctor, 15307176219, 2891533@qq.com

    Not yet recruiting

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu, 733099

    Linzhi Lu, Bachelor, 13659359016, lulinzh12006@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University Medical College

    Xi'an, Shaanxi, 710000

    Aili Suo, Doctor, 18991232561, Ailisuo@mail.xjtu.edu.cn

    Not yet recruiting

  • XuZhou Central Hospital

    Xuzhou, Jiangsu, 221000

    Yuan Yuan, Doctor, 15351687303, wwww8866@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450002

    Feng Wang, Doctor, 13938244776, fengw010@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Being tested
LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine, LM-108 injection 10mg/kg +penpulimab, LM-108 injection 600mg + penpulimab, enpulimab+ Oxaliplatin+Capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LM-108 injection+Penpulimab+ Oxaliplatin+CapecitabineDrug

    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+CapecitabineDrug

    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 +penpulimabDrug

    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 + penpulimabDrug

    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.

  • enpulimab+ Oxaliplatin+CapecitabineDrug

    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.

Study groups in NCT06825494
Study groupRoleWhat they receive
LM-108 injection+Penpulimab+ Oxaliplatin+CapecitabineExperimentalLM-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
Receives: Drug: LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine
Tislelizumab+Oxaliplatin+CapecitabineExperimentalTislelizumab: 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.
Receives: Drug: Tislelizumab+Oxaliplatin+Capecitabine
LM-108 injection 10mg/kg +penpulimabExperimentalLM-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.
Receives: Drug: LM-108 injection 10mg/kg +penpulimab
LM-108 injection 600mg + penpulimabExperimentalLM-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.
Receives: Drug: LM-108 injection 600mg + penpulimab
Penpulimab+ Oxaliplatin+CapecitabineExperimentalPenpulimab: 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.
Receives: Drug: enpulimab+ Oxaliplatin+Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicity (DLT) events

    Incidence of Phase Ib DLT events for Cohort A1.

    Measured: From first dose to 21days after first dose

  2. Progression-free survival (PFS)

    Defined as the time from first dose to first occurrence of disease progression or death due to any cause.

    Measured: The estimated time from randomization to patient disease progression was 10 months

Secondary outcomes (13)

  1. Overall response rate (ORR)

    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).

    Measured: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient

  2. Duration of response (DOR)

    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.

    Measured: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient

  3. Disease control rate (DCR)

    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.

    Measured: The estimated duration was 16 months from enrollment of the first patient to 10 months after enrollment of the last patient

  4. Overall survival (OS)

    The time from randomization to death due to any cause.

    Measured: From randomization until patient death, it is expected to be evaluated up to 5 years

  5. Number of patients with adverse events (AEs) and serious adverse events (SAEs)

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Baseline up to 90 days after the last dose

  6. AE/SAE severity

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: Baseline up to 90 days after the last dose

  7. Cmax

    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.

    Measured: 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

  8. Tmax

    The time it takes to reach the peak concentration after dosing.

    Measured: 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

  9. T1/2

    The time it takes for the concentration of the drug to drop by half.

    Measured: 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

  10. Clearance rate (CL)

    The number of apparent volumes of distribution of the drug cleared from the body per unit of time.

    Measured: 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

  11. Apparent volume of distribution (Vz)

    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

    Measured: 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

  12. Incidence of Immunogenicity indicators: anti-drug antibodies (ADA)

    Usually refers specifically to antidrug-binding antibodies.

    Measured: 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

  13. Incidence of Immunogenicity indicators: neutralizing antibodies (Nab)

    Refers to anti-drug antibodies that interfere with the interaction of a drug with its target.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start8 Apr 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06825494
Sponsor's protocol ID
LM-108-Ib/II-01-A
Status last verified
Nov 2025
First submitted
9 Feb 2025
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine and LM-108 injection 10mg/kg +penpulimab in people with Advanced Solid Tumor, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 32 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Lin Shen, Doctor (010-88196561, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicity (DLT) events (time frame: From first dose to 21days after first dose). 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?

On the ClinicalTrials.gov record for NCT06825494.

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 18 Dec 2025.

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