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

Not Applicable

Recruiting

• Conditions: Solid Tumors
• Interventions: Drug: RC278

• Registration Number: NCT07105215
• Lead Sponsor: RemeGen Co., Ltd.

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;

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-29
• Status Verified: 2025-08
• Study First Posted: 2025-08-05
• Study Start: 2025-08-11
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-17
• Primary Completion: 2027-12-31
• Study Completion: 2030-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

1. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
2. Age between 18 and 75 years (including 18 and 75 years);
3. ECOG PS score of 0 or 1;
4. Expected survival ≥12 weeks;
5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
6. Sufficient bone marrow, liver, kidney, and blood clotting function

Exclusion Criteria

1. Pregnant, breastfeeding, or intending to become pregnant subjects.
2. Subjects with brain metastases.
3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
5. Subjects with acute, chronic, or symptomatic infections.
6. Subjects with uncontrolled cardiovascular diseases.
7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
8. Subjects with a history of cirrhosis (Child-Pugh B or C class).
9. Subjects with active inflammatory bowel disease.
10. Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
11. Subjects who experienced arterial/venous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.
12. 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.
13. Subjects with active autoimmune diseases requiring systemic treatment within the past 2 years.
14. 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.
15. Subjects with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.
16. Subjects with a history or current diagnosis of uncontrolled psychiatric disorders.
17. Subjects with poor adherence, who are unlikely to comply with the trial procedures.
18. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RC278 (Phase I, dose escalation)	RC278	There are five escalating dose cohorts.
RC278 (Phase I, dose expansion)	RC278	The recommended dose from the dose-escalation stage and other potential doses will be further explored.
RC278 (Phase I, dose optimization)	RC278	Based 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)	RC278	In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC278 in various cancer types using the RP2D.

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity (DLT)	24 months	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.
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v5.0)	24 months	AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the CTCAE Version 5.0\].
Determine RP2D of RC278	24 months	To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.
MTD and/or MAD	24 months	To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.
Investigator assessed ORR according to RECIST v1.1 criteria	24 months	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).

Trial Locations

Locations (6)

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