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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05508334

Enrollment

Registered

2022-08-19

Start date

2023-01-30

Completion date

2025-11-26

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumours

Brief 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

Detailed 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.

Interventions

DRUGRC88

Every 2 weeks for a maximum of 2 years

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
RP2D	28 days after first treatment	Incidence of DLT (dose limiting toxicity) of RC88

Secondary

Measure	Time frame	Description
Objective Response Rate (ORR)	24 months	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Maximum Concentration (Cmax) of RC88	pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours	Dose Escalation and Expansion Part
Terminal Half Life (t1/2) of RC88	pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours	Dose Escalation and Expansion Part
Progression Free Survival (PFS)	24 months	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026