A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
NCT ID: NCT06038396
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2023-08-03
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
NCT06016062
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
NCT05302284
Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
NCT06127303
A Study of GFH018 in Combination With Toripalimab in Patients With Advanced Solid Tumors
NCT04914286
A Phase Ib/II Clinical Study of LBL-007 in Combination With Toripalimab in Treatment of Advanced Malignant Tumors
NCT05102006
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A-RC118 plus Toripalimab
Participants receive RC118- ADC(dose A or dose B) Q2W and Toripalimab (fixed dose) Q3W
RC118
Dose A or dose B, Q2W
Toripalimab
Fixed dose, Q3W
Part B-RC118 plus Toripalimab / RC148
Referring to the results of the Part A, an extension cohort using RC118 plus Toripalimab /RC148 will be established.
RC118
Dose A or dose B, Q2W
Toripalimab
Fixed dose, Q3W
RC148
Fixed dose, Q3W Other Names: RC148 injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RC118
Dose A or dose B, Q2W
Toripalimab
Fixed dose, Q3W
RC148
Fixed dose, Q3W Other Names: RC148 injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. male or female 18 ≤ age ≤ 75 years old.
3. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. The expected survival ≥12 weeks.
5. Enrollment of subjects with locally advanced or metastatic gastric adenocarcinoma/adenocarcinoma of the gastroesophageal junction who have a histologically confirmed diagnosis and have failed standard therapy.
6. Subjects who received ≤2 prior systemic therapies.
7. Subjects agree to provide tumor tissue specimens for Claudin 18.2 and PD-L1 expression levels during the screening period. Samples should have moderate to high expression of Claudin 18.2 by membrane staining.
8. According to the RECIST v1.1, there is at least one measurable target lesion.
9. Sufficient heart, bone marrow, liver and kidney functions.
10. Fertile male or female subjects must agree to take effective contraceptive measures during the study period and for 6 months after the end of the last dose, such as double-barrier contraceptive methods(eg. condoms), oral or injectable contraceptives, intrauterine.
Exclusion Criteria
2. Subjects with active hepatitis B (HBsAg positivity and HBV DNA titre higher than the normal upper limit), active hepatitis C (HCVAb positivity and HCV RNA titre higher than the normal upper limit), and positive human immunodeficiency virus antibody (HIV-Ab) results during the screening period.
3. Subjects with a history of other acquired or congenital immunodeficiency diseases, or who have undergone organ or bone marrow transplantation.
4. Subjects who have previously received monoclonal antibody, double antibody targeting drugs, ADC, CAR-T and other therapeutic drugs targeting Claudin 18.2 or other ADCs with MMAE payload; or have participated in clinical trials and received investigational drugs within 4 weeks before the first dose.
5. Have vaccinated within 4 weeks prior to the first dose or plan to receive any live vaccine during the study.
6. Subjects are atallergic to the ingredients or excipients of the experimental drug.
7. Subjects who have received anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy, or targeted therapy) within 4 weeks or less than 5 half-lives of the experimental drug prior to the start of the first dose; or who have received anti-tumor therapy with traditional Chinese medicine or immunomodulators within 2 weeks prior to the start of the first dose.
8. The toxicity of previous anti-tumor therapy has not returned to the level 0 or 1 as defined by NCI-CTCAE v5.0 (except for alopecia, pigmentation and other long-term toxicity ≤2 that cannot be recovered which was defined by investigators).
9. The clinical symptoms of pleural effusion, abdominal effusion, or pericardial effusion that requires drainage.
10. Active infection within 2 weeks prior to the first dose that requires systemic anti-inflammatory therapy.
11. Complicating other diseases that seriously endanger the safety of the subjects or affect the completion of the study, such as peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure and uncontrolled diabetes (Fasting blood glucose \> 8.5 mmol/L, HbA1C ≥7.5%).
12. The tumor lesion has a bleeding tendency or has received blood transfusion treatment within 4 weeks prior to the first dose.
13. During the screening period, QTc interval \>450 ms(male), QTc interval \>470ms(female); previous family or personal history of long/short QT interval syndrome; A history of ventricular arrhythmia deemed clinically significant by the investigator, or currently receiving antiarrhythmic medication, or implantation of arrhythmia defibrillation device.
14. Previous myocardial infarction (within 6 months prior to the first dose), severe or unstable angina, coronary or peripheral artery bypass grafting, heart failure grade 3\~4 defined by New York Heart Association (NYHA) and uncontrolled hypertension.
15. Experienced an arterial/venous thromboembolic event within 6 months prior to the study.
16. Active autoimmune disease that requires systemic treatment within 2 years prior to the study. Patients with vitiligo, psoriasis, alopecia or Grave's disease that not requires systemic treatment, hypothyroidism that only requires thyroid hormone replacement therapy, and type 1 diabetes only requires insulin replacement therapy may be included in the study.
17. Subjects with brain metastases and/or carcinomatous meningitis who have previously received related treatment may be considered for inclusion if their disease has been stable for at least 3 months, no imaging evidence of disease progression has been observed within 4 weeks prior to the first dose, all neurological symptoms have returned to baseline, and radiation, surgery, or steroid therapy has been discontinued at least 28 days prior to the first dose; cancerous meningitis should be excluded regardless of whether it is clinically stable.
18. Other malignant tumor within 5 years prior to the signature of informed consent.
19. Major surgery or interventional therapy was performed within 4 weeks prior to the first dose and did not fully recovered (except tumor biopsy and puncture).
20. For Phase II subjects:
* Received an immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to the first treatment with the test drug;
* Prior concurrent receipt of antitumor agents targeting VEGF/VEGFR and PD-1/PD-L1;
* Experienced permanent discontinuation of immunotherapy due to toxicity of immune checkpoint inhibitor therapy prior to receiving administration of study drug;
* Currently receiving anticoagulant medications (except for subjects on prophylactic doses of heparin).
21. A history of uncontrollable mental illness or subjects currently experiencing such conditions.
22. Subjects with poor compliance who are expected to be unable to complete the study.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RemeGen Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tianshu Liu, ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Nanyang Central Hospital
Nanyang, Henan, China
Xinyang Central Hospital
Xinyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Shandong, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Changzhi People's Hospital
Changzhi, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Zhongshan Hospital Fudan University
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC118-C002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.