A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor
1 other identifier
interventional
312
1 country
39
Brief Summary
The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D)， and assess the efficacy of RC278 at the RP2D dose;
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2025
Longer than P75 for phase_1
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedStudy Start
First participant enrolled
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2030
November 26, 2025
August 1, 2025
2.4 years
July 22, 2025
November 24, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Dose-Limiting Toxicity (DLT)
DLT is defined as the adverse events (AEs) occurring during the DLT observation period that the investigator determines to be related to the RC278 treatment.
24 months
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v5.0)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the CTCAE Version 5.0\].
24 months
Determine RP2D of RC278
To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.
24 months
MTD and/or MAD
To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.
24 months
Investigator assessed ORR according to RECIST v1.1 criteria
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).
24 months
Study Arms (4)
RC278 (Phase I, dose escalation)
EXPERIMENTALThere are five escalating dose cohorts.
RC278 (Phase I, dose expansion)
EXPERIMENTALThe recommended dose from the dose-escalation stage and other potential doses will be further explored.
RC278 (Phase I, dose optimization)
EXPERIMENTALBased on the safety, pharmacokinetic (PK), and efficacy data from the subjects, select at least two dose levels and randomly assign subjects in a 1:1 ratio to determine the recommended Phase II dose (RP2D) for entering the Phase II stage.
RC278 (Phase II)
EXPERIMENTALIn the multi-indication cohort expansion phase, further assess the efficacy and safety of RC278 in various cancer types using the RP2D.
Interventions
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
Eligibility Criteria
You may qualify if:
- Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
- Age between 18 and 75 years (including 18 and 75 years);
- ECOG PS score of 0 or 1;
- Expected survival ≥12 weeks;
- According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
- Sufficient bone marrow, liver, kidney, and blood clotting function
You may not qualify if:
- Pregnant, breastfeeding, or intending to become pregnant subjects.
- Subjects with brain metastases.
- Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
- Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
- Subjects with acute, chronic, or symptomatic infections.
- Subjects with uncontrolled cardiovascular diseases.
- Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
- Subjects with a history of cirrhosis (Child-Pugh B or C class).
- Subjects with active inflammatory bowel disease.
- Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
- Subjects who experienced arterial/venous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.
- Subjects with pericardial effusion or cardiac tamponade, or third-space fluid accumulation, which, in the investigator's judgment, cannot be controlled or stabilized by drainage or other methods.
- Subjects with active autoimmune diseases requiring systemic treatment within the past 2 years.
- Subjects with a history of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from a previously diagnosed malignancy.
- Subjects with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Luoyan, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hu'Nan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of HUST, China
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Tumor Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School Of Medicine
Hangzhou, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Jinan Central Hospital
Jinan, China
Shanxi Cancer Hospital
Taiyuan, China
Henan Cancer Hospital
Zhengzhou, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
August 5, 2025
Study Start
August 11, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
May 31, 2030
Last Updated
November 26, 2025
Record last verified: 2025-08