Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07105215

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors

Led by RemeGen Co., Ltd. · Updated on 2025-11-26

312

Participants Needed

39

Research Sites

250 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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;

CONDITIONS

Official Title

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily participate and sign informed consent
  • Age between 18 and 75 years, inclusive
  • ECOG performance status of 0 or 1
  • Expected survival of at least 12 weeks
  • At least one measurable target lesion per RECIST v1.1 imaging criteria
  • Adequate bone marrow, liver, kidney, and blood clotting function
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or planning pregnancy
  • Presence of brain metastases
  • Unresolved toxicities from prior anti-tumor therapy not recovered to Grade 1
  • Known allergy or delayed hypersensitivity to components of RC278 or similar drugs
  • Acute, chronic, or symptomatic infections
  • Uncontrolled cardiovascular diseases
  • Confirmed or suspected interstitial lung disease or severe pulmonary conditions
  • History of cirrhosis classified as Child-Pugh B or C
  • Active inflammatory bowel disease
  • Uncontrolled diabetes with HbA1c ≥ 10%
  • Recent arterial/venous thromboembolic events or stroke within 6 months
  • Uncontrolled pericardial effusion, cardiac tamponade, or third-space fluid accumulation
  • Active autoimmune diseases requiring systemic treatment within 2 years
  • History of other invasive malignancies within 5 years or residual disease
  • History of immunodeficiency or organ transplantation
  • Uncontrolled psychiatric disorders
  • Poor adherence or unlikely to comply with study procedures
  • Any other medical condition or abnormality judged unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 39 locations

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Actively Recruiting

2

Fujian Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

3

Fujian Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

4

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Actively Recruiting

5

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Actively Recruiting

6

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Actively Recruiting

7

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

Nanning, Guangxi, China

Actively Recruiting

8

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Actively Recruiting

9

Anyang Cancer Hospital

Luoyan, Henan, China

Actively Recruiting

10

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China

Actively Recruiting

11

Nanyang Second General Hospital

Nanyang, Henan, China

Actively Recruiting

12

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Actively Recruiting

13

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

14

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China

Wuhan, Hu'Nan, China

Actively Recruiting

15

Hubei Cancer Hospital

Wuhan, Hubei, China

Actively Recruiting

16

Tongji Hospital, Tongji Medical College of HUST, China

Wuhan, Hubei, China

Actively Recruiting

17

Hunan Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

18

Hunan Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

19

Hunan Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

20

Hunan Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

21

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Actively Recruiting

22

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Actively Recruiting

23

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Actively Recruiting

24

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Actively Recruiting

25

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Actively Recruiting

26

The first Hospital of China Medical University

Shenyang, Liaoning, China

Actively Recruiting

27

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

28

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

29

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

30

Yunnan Tumor Hospital

Kunming, Yunnan, China

Actively Recruiting

31

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

32

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

33

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Actively Recruiting

34

Sun Yat-sen University Cancer Center

Guangzhou, China

Actively Recruiting

35

The First Affiliated Hospital, Zhejiang University School Of Medicine

Hangzhou, China

Actively Recruiting

36

Cancer Hospital of Shandong First Medical University

Jinan, China

Actively Recruiting

37

Jinan Central Hospital

Jinan, China

Actively Recruiting

38

Shanxi Cancer Hospital

Taiyuan, China

Actively Recruiting

39

Henan Cancer Hospital

Zhengzhou, China

Actively Recruiting

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Research Team

X

Xiaohong Su

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors | DecenTrialz