Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06825494

Clinical Studies for the Treatment of Advanced Solid Tumors

Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-12-18

194

Participants Needed

32

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Clinical Studies for the Treatment of Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be at least 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Have at least one measurable tumor lesion by RECIST v1.1
  • All acute toxicities from prior cancer treatments have resolved to Grade 0-1 or are not safety risks
  • Have adequate organ and bone marrow function as defined by specific blood counts, liver and kidney tests, coagulation, urine protein, and cardiac function
  • Expected survival of at least 12 weeks
  • Non-childbearing women or agreement to use approved contraception and negative pregnancy test if childbearing potential
  • Able and willing to comply with study visits, treatments, and procedures
  • For Cohorts A1 and A2: confirmed gastric or gastroesophageal junction cancer, HER2 negative, no prior systemic therapy for advanced disease, and provide tumor tissue samples
  • For Cohorts A3 and A4: confirmed advanced or metastatic solid tumors and failed at least one prior standard therapy
Not Eligible

You will not qualify if you...

  • Known Microsatellite Instability-High (MSI-H) or deficient mismatch repair (dMMR)
  • Uncontrolled or symptomatic active central nervous system metastases
  • Uncontrolled pleural effusion, ascites, or symptomatic pericardial effusion
  • Weight loss greater than 20% in the past 2 months
  • Prior treatment with CCR8 antibody, CTLA-4 antibody, or other drugs targeting regulatory T cells before enrollment
  • Major surgery within 28 days prior to enrollment except diagnostic procedures
  • Use of immunosuppressive medications within 14 days prior to enrollment except low-dose steroids or nasal/inhaled corticosteroids
  • Live attenuated vaccine within 28 days before enrollment or planned during study and 60 days after treatment
  • Anti-tumor therapy within 28 days prior to enrollment
  • Diagnosis of another malignancy within 5 years except certain treated skin and other specific cancers
  • Active or suspected autoimmune disease requiring systemic immunosuppression
  • Significant bleeding or thrombotic events within past 3 to 6 months
  • Severe wounds, ulcers, fractures, or grade >1 peripheral neuropathy
  • Recent gastrointestinal perforation, fistula, obstruction unless resolved by surgery
  • Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases
  • Known allergy to study drugs or other monoclonal antibodies
  • HIV infection, untreated active hepatitis B or C, or co-infection
  • Uncontrolled cardiac diseases or recent myocardial infarction
  • Recent systemic antibiotic use for 7 or more days or unexplained fever >38.5°C
  • History of allogeneic organ or stem cell transplantation
  • Participation in other drug trials within 4 weeks or 5 half-lives of last drug
  • History of psychotropic substance or drug abuse
  • Other serious physical or psychiatric illnesses or laboratory abnormalities that increase risk or interfere with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 32 locations

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China, 230031

Not Yet Recruiting

2

The Second Hospital of Anhui Medical University

Hefei, Anhui, China, 230601230601

Not Yet Recruiting

3

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

4

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Not Yet Recruiting

5

The First Hospital of Lanzhou University

Lanzhou, Gansu, China, 730030

Not Yet Recruiting

6

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China, 733099

Not Yet Recruiting

7

Peking University Shenzhen Hospita

Shenzhen, Guangdong, China, 518000

Not Yet Recruiting

8

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China, 530021

Not Yet Recruiting

9

Tangshan People's Hospital

Tangshan, Hebei, China, 063001

Not Yet Recruiting

10

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150040

Not Yet Recruiting

11

Nanyang Second General Hospital

Nanyang, Henan, China, 473012

Not Yet Recruiting

12

Ping mei shen ma Medical Group General Hospital

Pingdingshan, Henan, China, 467000

Actively Recruiting

13

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450002

Not Yet Recruiting

14

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Not Yet Recruiting

15

The second xiangya hospital of central south university

Changsha, Hunan, China, 410011

Not Yet Recruiting

16

Inner Mongolia Hospital of Peking University Cancer Hospita

Hohhot, Inner Mongolia, China, 010000

Not Yet Recruiting

17

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

18

NanJing Drum Tower Hospital

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

19

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Not Yet Recruiting

20

XuZhou Central Hospital

Xuzhou, Jiangsu, China, 221000

Not Yet Recruiting

21

Jilin Cancer Hospital

Changchun, Jilin, China, 130000

Not Yet Recruiting

22

The First Hospital Of China Medical University

Shenyang, Liaoning, China, 110000

Not Yet Recruiting

23

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

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

24

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China, 264000

Not Yet Recruiting

25

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Not Yet Recruiting

26

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200120

Not Yet Recruiting

27

First Hospital of Shangxi Medical University

Taiyuan, Shangxi, China, 030001

Not Yet Recruiting

28

Shanxi Cancer Hospital

Taiyuan, Shanxi, China, 030000

Not Yet Recruiting

29

Sichuan Cancer Hospita

Chengdu, Sichuan, China, 610042

Not Yet Recruiting

30

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China, 300000

Not Yet Recruiting

31

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, China, 830054

Not Yet Recruiting

32

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325005

Not Yet Recruiting

Loading map...

Research Team

L

Lin Shen, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here