Clinical Studies for the Treatment of Advanced Solid Tumors

NCT06825494 | Recruiting Phase 1

• 1 other identifier: LM-108-Ib/II-01-A
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 32

Brief 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. 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLT) events

  Incidence of Phase Ib DLT events for Cohort A1.

  From first dose to 21days after first dose

• Progression-free survival (PFS)

  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 Outcomes (13)

• Overall response rate (ORR)

  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)

  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)

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

• Overall survival (OS)

  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)

  Baseline up to 90 days after the last dose

Study Arms (5)

LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

EXPERIMENTAL

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

Tislelizumab+Oxaliplatin+Capecitabine

EXPERIMENTAL

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

LM-108 injection 10mg/kg +penpulimab

EXPERIMENTAL

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-108 injection 600mg + penpulimab

EXPERIMENTAL

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

Penpulimab+ Oxaliplatin+Capecitabine

EXPERIMENTAL

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

Interventions

LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine 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.

LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

Tislelizumab+Oxaliplatin+Capecitabine 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.

Tislelizumab+Oxaliplatin+Capecitabine

LM-108 injection 10mg/kg +penpulimab 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 10mg/kg +penpulimab

LM-108 injection 600mg + penpulimab 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.

LM-108 injection 600mg + penpulimab

enpulimab+ Oxaliplatin+Capecitabine 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.

Penpulimab+ Oxaliplatin+Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (32)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

NOT YET RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601230601, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

NOT YET RECRUITING

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, 733099, China

NOT YET RECRUITING

Peking University Shenzhen Hospita

Shenzhen, Guangdong, 518000, China

NOT YET RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

NOT YET RECRUITING

Tangshan People's Hospital

Tangshan, Hebei, 063001, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150040, China

NOT YET RECRUITING

Nanyang Second General Hospital

Nanyang, Henan, 473012, China

NOT YET RECRUITING

Ping mei shen ma Medical Group General Hospital

Pingdingshan, Henan, 467000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450002, China

NOT YET RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

The second xiangya hospital of central south university

Changsha, Hunan, 410011, China

NOT YET RECRUITING

Inner Mongolia Hospital of Peking University Cancer Hospita

Hohhot, Inner Mongolia, 010000, China

NOT YET RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

NanJing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

NOT YET RECRUITING

XuZhou Central Hospital

Xuzhou, Jiangsu, 221000, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, 130000, China

NOT YET RECRUITING

The First Hospital Of China Medical University

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

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

Xi'an, Shaanxi, 710000, China

NOT YET RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 264000, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

NOT YET RECRUITING

First Hospital of Shangxi Medical University

Taiyuan, Shangxi, 030001, China

NOT YET RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

NOT YET RECRUITING

Sichuan Cancer Hospita

Chengdu, Sichuan, 610042, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, 830054, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325005, China

NOT YET RECRUITING

MeSH Terms

Interventions

penpulimab

Central Study Contacts

Lin Shen, Doctor

CONTACT

010-88196561; doctorshenlin@sina.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: April 8, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Locations

CN (32)