* Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor * Pharmacokinetic parameters will be calculated for DCBCI0901, if data permit. * Anti tumor activity: The efficacy endpoint will be the overall response rate (ORR) defined as the proportion of patients who continuously receive treatment after Cycle 1 with a best overall response of complete response (CR) or partial response (PR).
This is a Phase I, open label, first in human study designed to evaluate the safety, tolerability and PK of escalating doses of DCBCI0901 in patients with advanced solid tumors. Each treatment cycle will be 28 days in duration with no gap between cycles. During each cycle, DCBCI0901 will be administered slowly as a 30 minute intravenous (IV) infusion (use of infusion pump preferred) once daily (QD) in the first 5 day dosing period (Days 1 to 5), which will be followed by 9 days of recovery and observation (Days 6 14). DCBCI0901 will be administered intravenously QD in a second 5 day dosing period (Days 15 through 19), followed again by 9 days of recovery and observation (Days 20 through 28). Patients may continue to receive treatment in 28 day cycles after completion of Cycle 1. To qualify for continued treatment beyond Cycle 1, all of the following criteria must be fulfilled: * The patient is willing to receive further treatment * Toxicity induced by the IP is not considered to be unbearable as judged by the Investigator * The patient does not have PD as defined by Response Evaluation Criteria in Solid Tumors * The patient satisfies the criteria for dosing * The patient does not meet any of the criteria for withdrawal After the first cycle, CT/MRI assessment will be performed once every 8 weeks (2 cycles) for efficacy evaluation, or per Investigator judgment. After the first year of treatment, the Investigator will assess the patient using CT/MRI based on his/her discretion. Safety data will be evaluated according to normal practice. Upon discontinuation of study treatment (if applicable), assessments for the Early termination visit (if discontinuation occurs in Cycle 1) or End of Treatment visit (if discontinuation occurs in Cycle 2 or onwards) should occur within 3 days of discontinuation. Assessments for the Follow up visit (10 days \[±1 day\] after the last dose of IP) and End of Study (EOS) visit (30 days \[±3 days\] after the last dose of IP)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
DCBCI0901 7.5mg/m2 iv infusion for day 1 to day 5 and day 15 to day 20
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
• Investigate the safety and tolerability of multiple DCBCI0901 infusions in patients with advanced solid tumor
AE and SAE, physical examination, vital signs, weight, clinical laboratory examinations (hematology, blood chemistry, blood coagulation, and urinalysis), pulmonary function tests, pulse oximetry, and ECGs. Adverse events and SAEs will be collected from the time of informed consent, throughout the study, until the EOS visit or up to 1 year of treatment.
Time frame: one year
• Pharmacokinetic parameters as described below will be calculated for DCBCI0901, if data permit.
Pharmacokinetic parameters will be determined from DCBCI0901 plasma concentrations using noncompartmental methods. DCBCI0901 PK parameters to be calculated (if adequate data are available for estimation) will include Cmax, time to Cmax (tmax), applicable AUC parameters such as AUC from time zero to the last quantifiable time point (AUC(0 last)), AUC from time zero to infinity (AUC(0 inf)), and/or AUC over the dosing interval tau (AUC(0 tau)), terminal half life (t1/2), systemic clearance (CL), steady state volume of distribution and volume of distribution in the terminal phase (Vss and Vz, respectively), and multiple/single dose accumulation parameters for Cmax and AUC (RCmax and RAUC).
Time frame: 28
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