Advanced Malignant Solid Tumors
Conditions
Brief summary
The goal of this clinical trial is to learn the safety, tolerability, pharmacokinetic characteristics and efficacy of FC084CSA in combination with Tislelizumab in patients with advanced malignant solid tumors.
Detailed description
The study includes two phases. Phase Ib adopts a "3+3" dose escalation design to assess safety and tolerability of increasing dose levels of FC084CSA in combination of fixed dose of Tislelizumab. Phase IIa is the dose expansion phase to further observe the preliminary effectiveness of the recommended Phase 2 Dose of FC084CSA in combination of Tislelizumab.
Interventions
DRUGFC084CSA+Tislelizumab combination (dose escalation)
Increasing dose levels of FC084CSA+fixed dose Tislelizumab combination therapy
DRUGRP2D of FC084CSA+Tislelizumab combination (dose expansion)
RP2D of FC084CSA+fixed dose Tislelizumab combination therapy
Sponsors
FindCure Biosciences (ZhongShan) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
FC084CSA in combination with Tislelizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75 years old male and female. 2. Phase Ib: Patients with histologically or cytologically diagnosed solid tumors who have failed standard therapy; Phase IIa: Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV NSCLC which surgery or radiotherapy cannot be performed. 3. No known sensitizing mutations or other actionable oncogenes with approved therapies if available. 4. Prior PD-1/PD-L1 inhibitor combined with platinum-containing therapy failed; 5. According to RECIST 1.1, there is at least one measurable lesion. 6. ECOG performance status 0-1. 7. Major organs are functioning well.
Exclusion criteria
1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1). 2. Received anti-tumor therapy within 4 weeks before enrollment. 3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started. 5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods. 6. Central nervous system metastases with clinical symptoms. 7. With any situations that the researcher considers inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Maximum Tolerated Dose (MTD) | Approximately 8 months | The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee. |
| Determine the Recommended Phase 2 Dose (RP2D) | Approximately 8 months | The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD. |
| Determine dose-limiting toxicity (DLT) | 21 days after first dose | Determine the DLT of FC084CSA |
| Objective response rate (ORR) | Approximately 12 months | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Approximately 12 months | DCR as assessed using RECIST 1.1 |
| Progression free survival (PFS) | Approximately 12 months | PFS as assessed using RECIST 1.1 |
| Overal suvival (OS) | Approximately 18 months | It is defined as the time from date of first dose to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates. |
| Pharmacokinetic (PK) Cmax | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Pharmacokinetic (PK) Tmax | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Pharmacokinetic (PK) AUC 0-t | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Pharmacokinetic (PK) AUC 0-∞ | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
Countries
China
Contacts
CONTACTTingjin Wang
PRINCIPAL_INVESTIGATORCaicun Zhou
Shanghai East Hospital
Outcome results
None listed