A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Advanced Solid Tumours Clinical Trial

Official title:

An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508334
• Other study ID #: RC88 C002
• Status: Recruiting
• Phase: Phase 1
• Start date: January 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: RemeGen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

Description:

The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. All subjects must be = 18 years at the first screening examination / visit.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

3. Life expectancy of at least 12 weeks

4. Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors;

5. Phase II-Advanced malignant solid tumor with MSLN expression

6. Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria

7. Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory.

8. Adequate organ function

9. Voluntarily sign an informed consent form

Exclusion Criteria:

1. Cancer metastases in the brain

2. Active infection or past hepatitis B or C infection

3. Major surgery less than 1 month before the start of the study

4. Uncontrolled heart disease

5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds

Related Conditions & MeSH terms

• Advanced Solid Tumours
• Neoplasms

Intervention

Drug:
• RC88
Every 2 weeks for a maximum of 2 years

Locations

Country	Name	City	State
China	Remegen	Beijing	Beijing
China	Remgenen	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RP2D	Incidence of DLT (dose limiting toxicity) of RC88	28 days after first treatment
Secondary	Objective Response Rate (ORR)	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)	24 months
Secondary	Maximum Concentration (Cmax) of RC88	Dose Escalation and Expansion Part	pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
Secondary	Terminal Half Life (t1/2) of RC88	Dose Escalation and Expansion Part	pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
Secondary	Progression Free Survival (PFS)	Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	24 months