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Use PT-112 alone for Phase I dose escalation stage: advanced solid tumors, Phase I dose confirmation stage: advanced solid tumors. Phase II hepatocellular carcinoma (HCC). To evaluate the safety and tolerability of PT-112 injection from 250mg/m2 dose level with 3+3 dose escalation design, find Maximum tolerated dose (MTD), Recommended Phase II Dose(RP2D) and evaluate the Pharmacokinetic (PK) profile of PT-112 through Phase I dose escalation stage. Phase I dose confirmation stage: evaluate the safety and tolerability of PT-112 with RP2D, evaluate the anti-tumor effect of PT-112 at RP2D. Phase II stage: evaluate the anti-tumor effect of PT-112 at RP2D in advanced HCC
Full description
This is a multicenter, open-label, phase I/II clinical trial that includes the dose escalation stage, dose confirmation stage and phase II stage.
In dose escalation stage, a 3+3 trial design is adopted for dose escalation. Three dose groups are designed: 200, 250 and 300 mg/m2, once weekly; 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period. The safety, tolerability, PK and preliminary antitumor effect of PT-112 injection alone are evaluated. After Dose limited toxicity (DLT) evaluation is completed for all the patients in a dose group, the Safety Monitoring Committee (SMC) will evaluate the safety and PK of the dose group based on the resulting data, and decide whether the dose should be escalated, and whether the dosing regimen or PK sampling points should be adjusted.
After dose escalation is completed, the RP2D is selected by SMC for dose confirmation. Dose confirmation study will include approximately 10 patients each of the following six types of tumors:
Group 1: Hepatocellular carcinoma Group 2: Gastric cancer Group 3: Colorectal cancer Group 4: Non-small cell lung cancer Group 5: Head and neck cancer Group 6: Breast cancer If it is difficult to include the patients with a specific type of tumor, or if the tumor is not sensitive to the efficacy of investigational drug, the SMC may discuss and decide to prematurely terminate inclusion of patients in that group.
After sufficient data are obtained in dose confirmation stage, the SMC may discuss and decide to initiate phase II trial. Phase II trial plans to include about 40 subjects to evaluate the anti-tumor effect and safety of the monotherapy in patients with advanced HCC who have previously received only one systemic anticancer therapy.
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Inclusion criteria
Generally normal bone marrow reserve: absolute neutrophil count (ANC)
≥1.5*10^9/L, platelet count≥100*10^9/L and hemoglobin≥90 g/L; Generally normal liver function: serum albumin ≥3.0 g/dL; bilirubin ≤1.5×upper limits of normal (ULN), Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5×ULN, ALT or AST ≤5×ULN for patients with liver metastases or primary liver cancer; Normal renal function: creatinine ≤1.5×ULN or creatinine clearance ≥60ml/min (according to Cockcroft-Gault formula); Generally normal coagulation function: International Normalized Ratio(INR)≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN; Cardiac function: Left ventricular ejection fraction (LVEF)≥ 50%;
Other inclusion criteria for the phase II trial:
Advanced HCC diagnosed by histopathology or cytology that cannot be surgically removed or progresses after intervention/local treatment, previous treatment with one systemic anti-cancer chemotherapy, Barcelona Clinic Liver Cancer (BCLC) staging: Stage C, Child-Pugh A and mild grade B (≤7);
Exclusion criteria
Other exclusion criteria for the phase II trial:
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125 participants in 1 patient group
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Central trial contact
Jin Li, MD; Crystal Qin, MD, PhD
Data sourced from clinicaltrials.gov
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