Advanced Solid Tumours
Conditions
Brief summary
This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours
Interventions
Sintilimab 200mg by intravenous (IV) infusion，every 3 weeks
DRUGRC88
1.5mg/kg ，2.0mg/kg ，2.5mg/kg by intravenous (IV) infusion，every 3 weeks
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary agreement to provide written informed consen 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 3. Predicted survival ≥ 12 weeks 4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma; 5. Adequate organ function required 6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
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 combined with Sintilimab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactHeping Liu
Outcome results
None listed