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Solid TumorsPhase 1/2NCT07105215

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

A Phase 1/2 study testing RC278 in people with Solid Tumors, run by RemeGen Co., Ltd. at 39 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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; Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors
What is being tested?
RC278
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
39 sitesChina
Study dates
11 Aug 2025to 31 May 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • Subjects with a history or current diagnosis of uncontrolled psychiatric disorders.
  • Subjects with poor adherence, who are unlikely to comply with the trial procedures.
  • Subjects with any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities, which, in the investigator's judgment, raise suspicion of an underlying condition making the subject unsuitable for the investigational drug, or which may affect the interpretation of the study results, or place the subject at high risk.

Trial locations and contacts

39 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohong Su contact

+8610-65018841

na.su@remegen.com

39 sites in 1 country

China39 sites, 39 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Hu Xingsheng

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Liu Zhenyang

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Jiang Shusuan

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Ouyang Quchang

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Wu lin

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Li mei

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Guo Zengqing

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Huang Zhangzhou

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Lai jinhuo

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    xu ruihua

    Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

    Li Bihui

    Recruiting

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

    Hangzhou, Zhejiang

    Fang yong

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Fanyun

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School Of Medicine

    Hangzhou

    Zhao qingwei

    Fang weijia

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Wang guangyu

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan

    Zhang yan

    Wang linlin

    Recruiting

  • Jinan Central Hospital

    Jinan

    Wen qing

    Sun meili

    Recruiting

  • Yunnan Tumor Hospital

    Kunming, Yunnan

    Yang Runxiang

    Recruiting

  • Anyang Cancer Hospital

    Luoyan, Henan

    Ji yuanyuan

    Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Sun Longhua

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Gu yanhong

    Recruiting

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute

    Nanning, Guangxi

    Zhang Qingyun

    Recruiting

  • Nanyang Second General Hospital

    Nanyang, Henan

    Wang Qichuan

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Chen Zhiyu

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Yu yiwei

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

    Liu Hongxv

    Recruiting

  • The first Hospital of China Medical University

    Shenyang, Liaoning

    Zhao Mingfang

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan

    Wang xin

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Lv Dongqing

    Recruiting

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

    Wuhan, Hu'Nan

    Zhang tao

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Liang xinjun

    Yang bin

    Recruiting

  • Tongji Hospital, Tongji Medical College of HUST, China

    Wuhan, Hubei

    Chu qian

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Wu Jingxun

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

    Ji Yinghua

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Zhang Wenhui

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

    Han liang

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Jin shuiling

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Luo suxia

    Recruiting

Other trials in China

About this study

Official title: 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

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
Solid Tumors
Being tested
RC278

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC278Drug

    Also called RC278 For Injection

    Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.

Study groups in NCT07105215
Study groupRoleWhat they receive
RC278 (Phase I, dose escalation)ExperimentalThere are five escalating dose cohorts.
Receives: Drug: RC278
RC278 (Phase I, dose expansion)ExperimentalThe recommended dose from the dose-escalation stage and other potential doses will be further explored.
Receives: Drug: RC278
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.
Receives: Drug: RC278
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.
Receives: Drug: RC278

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

  2. 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].

    Measured: 24 months

  3. Determine RP2D of RC278

    To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.

    Measured: 24 months

  4. MTD and/or MAD

    To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.

    Measured: 24 months

  5. 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).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start11 Aug 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105215
Sponsor's protocol ID
RC278-C001
Status last verified
Aug 2025
First submitted
22 Jul 2025
Last updated
26 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RC278 in people with Solid Tumors, run by RemeGen Co., Ltd. at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaohong Su (+8610-65018841, na.su@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07105215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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