Actively Recruiting
A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
Led by RemeGen Co., Ltd. · Updated on 2025-01-29
48
Participants Needed
18
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to establish the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); The Phase II study will evaluate the efficacy and safety of RC118 in combination with Toripalimab or RC148 in patients with locally advanced or metastatic Gastric cancer/Gastro-esophageal junction cancer.
CONDITIONS
Official Title
A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to participate voluntarily and provide written informed consent
- Male or female aged 18 to 75 years
- ECOG Performance Status of 0 or 1
- Expected survival of at least 12 weeks
- Histologically confirmed locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that failed standard therapy
- Received two or fewer prior systemic therapies
- Agree to provide tumor tissue specimens showing moderate to high Claudin 18.2 expression by membrane staining
- At least one measurable target lesion according to RECIST v1.1
- Sufficient heart, bone marrow, liver, and kidney functions
- Fertile participants must agree to effective contraception during study and for 6 months after last dose
You will not qualify if you...
- Pregnant or breastfeeding women, or positive pregnancy test during screening (non-fertile women exempt)
- Active hepatitis B or C infection, or positive HIV antibody during screening
- History of acquired or congenital immunodeficiency or organ/bone marrow transplantation
- Prior treatment with monoclonal antibodies or therapies targeting Claudin 18.2 or investigational drugs within 4 weeks before first dose
- Vaccination within 4 weeks before first dose or planned live vaccine during study
- Allergy to study drug ingredients
- Anti-tumor therapy within 4 weeks or less than 5 half-lives of study drug before first dose; or traditional Chinese medicine/immunomodulators within 2 weeks
- Previous anti-tumor therapy toxicities not resolved to grade 0 or 1 (except certain long-term toxicities)
- Pleural, abdominal, or pericardial effusion requiring drainage
- Active infection needing systemic anti-inflammatory treatment within 2 weeks
- Serious diseases endangering safety or study completion, including uncontrolled diabetes
- Tumor bleeding tendency or recent blood transfusion within 4 weeks
- Abnormal QTc interval or significant heart rhythm disorders
- Recent severe heart conditions or uncontrolled hypertension
- Arterial or venous thromboembolic event within 6 months
- Active autoimmune disease needing systemic treatment within 2 years, except certain controlled conditions
- Brain metastases or carcinomatous meningitis unless stable and treated as specified
- Other malignancy within 5 years
- Major surgery or intervention within 4 weeks not fully recovered
- Phase II subjects with recent immune checkpoint inhibitor or anti-VEGF therapy, or on certain anticoagulants
- Uncontrollable mental illness
- Poor compliance expected to prevent study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
3
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Actively Recruiting
4
Meizhou People's Hospital
Meizhou, Guangdong, China
Actively Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
6
Nanyang Central Hospital
Nanyang, Henan, China
Actively Recruiting
7
Xinyang Central Hospital
Xinyang, Henan, China
Actively Recruiting
8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
9
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
10
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
11
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Shandong, China
Actively Recruiting
12
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
13
Changzhi People's Hospital
Changzhi, Shanxi, China
Actively Recruiting
14
West China Hospital Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
15
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Actively Recruiting
16
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
17
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
18
Zhongshan Hospital Fudan University
Shanghai, China
Actively Recruiting
Research Team
X
Xiaohong Su
CONTACT
T
Tianshu Liu, ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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