A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors

NCT07537881 | Not Yet Recruiting Phase 1

• 1 other identifier: RC288-C101
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the safety and tolerability of RC288; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC288 at the RP2D dose;

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (6)

• Dose-Limiting Toxicity (DLT)

  24 months

• Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0)

  24 months

• Determine RP2D of RC288

  24 months

• MTD and/or MAD

  24 months

• Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria

  24 months

• Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria

  24 months

Study Arms (2)

RC288 (Phase I, dose escalation)

EXPERIMENTAL

There are six predefined escalating dose levels.

Drug: RC288 For Injection

RC288 (Phase II, dose expansion)

EXPERIMENTAL

In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC288 in various cancer types using the RP2D.

Drug: RC288 For Injection

Interventions

RC288 For Injection DRUG

Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.

RC288 (Phase I, dose escalation)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 v6.0 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.
• History of underlying pulmonary disease.
• Subjects with a history of cirrhosis (Child-Pugh B or C class).
• Clinically significant gastrointestinal disease.
• Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
• Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening.
• Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation.
• History of arterial/venous thromboembolic events within 6 months prior to the first dose.
• Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Heping Liu

CONTACT

+8610-65384976; heping.liu@remegen.com

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: April 12, 2026
• First Posted: April 17, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)