Actively Recruiting
A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
Led by RemeGen Co., Ltd. · Updated on 2025-01-23
221
Participants Needed
31
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.
CONDITIONS
Official Title
A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to voluntarily participate and provide written informed consent
- Male or female aged 18 years or older for Phase I; 18 to 75 years for Phase II
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable target lesion by RECIST v1.1 imaging criteria
- For Phase I (RC148 monotherapy): Patients with locally advanced unresectable or metastatic malignant solid tumors progressed on or intolerant to standard therapy, or refused standard therapy
- For Phase II combination therapy cohorts: Specific tumor type and treatment history criteria apply as detailed in the protocol
- Agree to provide pre-treatment archived or biopsy tumor samples for biomarker testing
- Adequate bone marrow, liver, and kidney function as defined by lab criteria
- For certain lung cancer cohorts, oxygen saturation above 92% on room air
- Left ventricular ejection fraction of 50% or higher
- Agree to use effective contraception during study and for 6 months after last dose
You will not qualify if you...
- Pregnant or lactating
- Certain lung cancer patients with prior treatment exclusions or disease progression criteria
- Patients with specific ocular corneal conditions
- Active hepatitis B or C, or HIV positive
- Received live vaccine within 28 days before study or plans to receive during study
- History of immunodeficiency or organ transplant
- Active autoimmune disease requiring systemic therapy in past 2 years
- Immunotherapy within 28 days prior to study or discontinued due to toxicity
- Participation in other drug trials with test drug within 4 weeks
- Prior treatment with certain antitumor agents or antibody-drug conjugates
- Known hypersensitivity to study drug components
- On anticoagulant drugs other than prophylactic heparin
- Recent systemic antitumor therapy or herbal antitumor therapy within specified timeframes
- Unresolved adverse reactions from prior therapies
- Significant neuropathy grade 2 or higher
- Symptomatic third interstitial fluid or requiring intervention
- Active serious infections
- Recent or active significant bleeding or hemorrhagic conditions
- Systemic diseases not under stable control
- History or risk of interstitial lung disease or drug-associated pneumonia
- Clinically relevant pyelonephrosis not improved by intervention
- Recent gastrointestinal perforation, obstruction, or bowel surgery
- Abnormal heart rhythm or history of serious heart conditions
- Recent thromboembolic events or severe cardiovascular disease
- Use of high-dose corticosteroids or immunosuppressants within 2 weeks
- Unstable or untreated brain metastases except as detailed
- Recent major surgery without full recovery
- Tumor invasion of large blood vessels or vital organs posing bleeding risk
- Other malignancies within 5 years except treated curable cancers
- Uncontrolled mental illness
- Poor compliance or inability to complete study procedures
- Any condition judged by investigator to increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Anhui Provincial Hospital
Anhui, China
Actively Recruiting
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
3
Beijing University Cancer Hospital
Beijing, China
Actively Recruiting
4
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, China
Actively Recruiting
5
Jilin Cancer Hospital
Changchun, China
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
7
Hunan Second People's Hospital
Changsha, China
Actively Recruiting
8
Sichuan Cancer Hospital
Chengdu, China
Actively Recruiting
9
Chongqing University Cancer Hospital
Chongqing, China
Actively Recruiting
10
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
11
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
12
The Second Affiliated Hospital of Guilin Medical University
Guilin, China
Actively Recruiting
13
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
14
Harbin Medical University Cancer Hospital
Harbin, China
Actively Recruiting
15
Jinan Central Hospital
Jinan, China
Actively Recruiting
16
Qilu Hospital of shangdong university
Jinan, China
Actively Recruiting
17
Shandong Cancer Hospital
Jinan, China
Actively Recruiting
18
Meizhou People's Hospital
Meizhou, China
Actively Recruiting
19
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, China
Actively Recruiting
20
Nanyang City Center Hospital
Nanyang, China
Actively Recruiting
21
Nanyang Second General Hospital
Nanyang, China
Actively Recruiting
22
Shanghai Pulmonology Hospital
Shanghai, China
Actively Recruiting
23
Liaoning Cancer Hospital & Institute
Shenyang, China
Actively Recruiting
24
Shengjing Hospital of China Medical University
Shenyang, China
Actively Recruiting
25
Shanxi Provincial Tumor Hospital
Taiyuan, China
Actively Recruiting
26
Tongji Hospital, Tongji Medical College of HUST, China
Wuhan, China
Actively Recruiting
27
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, China
Actively Recruiting
28
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
29
Yunnan Cancer Hospital
Yunnan, China
Actively Recruiting
30
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
31
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
J
Jianming Fang, ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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