The study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and anti-tumor activity of CN202 in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies
This is a multi-centre, open-label, Phase I/II study in adult subjects with locally advanced or metastatic solid tumor or hematologic malignancies. The study consists of three parts Phase Ia: Dose Escalation: This is a dose escalation for assessment of dose-limiting toxicities (DLT) at approximately four dose levels in subjects with locally advanced or metastatic solid tumor or hematologic malignancies. Phase Ib: Dose Expansion: To evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CN202, prior to determination of Maximum tolerated dose (MTD) Phase II: To further evaluate the safety, tolerance, pharmacokinetic characteristics, and anti-tumor activity of CN202 in subjects with select tumors. All subjects will receive the recommended Phase II dose of CN202. There will be 13 to 24 subjects enrolled in phase Ia, 12 to 40 subjects in phase Ib and 15 to 100 subjects in phase II
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Participants will receive CN202 by IV infusion on Day 1 of each cycle (once every 2 weeks). The 4 planned dose levels are 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through adverse events as assessed by NCI-CTCAE v5.0
Number of participants with treatment related adverse events as assessed by NCI-CTCAE v5.0
Time frame: Measurements at Baseline till 90 days after the last dose of study drug
To evaluate the dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of CN202 when administered as a single-agent to subjects
Measured by Incidence of dose limiting toxicities (DLT) during the first cycle of treatment and DLT observation period
Time frame: DLT assessed within 21 days after the first dose of CN202
To identify a recommended Phase II dose (RP2D) of CN202
The recommended Phase II dose (RP2D) will be determined based on safety, efficacy, pharmacokinetics and pharmacodynamic date of CN202
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the anti-tumor activity of CN202 in selected solid tumors or hematologic malignancies as determined by Objective Response Rate (ORR)
Measured/determined by Objective Response Rate
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through Electrocardiogram (ECG)
Measured by ECG as assessed by the P wave, the QRS complex, and T wave
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by heart rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by body temperature
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by pulse, systolic blood pressure, and diastolic blood pressure
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the safety and tolerability of CN202 administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies through vital signs as assessed by respiratory rate
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The following parameter is used for evaluation during PK assessments: maximum concentration (Cmax)
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The following parameter is used for evaluation during PK assessments: area under the concentration-time curve (AUC)
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To evaluate the pharmacokinetic (PK) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The following parameter is used for evaluation during PK assessments: half-life (t½)
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To assess the immunogenic potential of CN202 by measuring anti-CN202 antibodies through Immunogenicity analysis test results
Measured through immunogenicity analysis test results (anti-drug antibodies and Neutralizing antibodies) and days from first dosing to positive result of anti-drug antibodies (ADA) or Neutralizing antibodies (NAb)
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months
To assess the pharmacodynamic (PD) of CN202 when administered to subjects with locally advanced or metastatic solid tumor or hematologic malignancies
The pharmacodynamic profile assessed based on the analysis of PD-L1 receptor occupancy (RO) and biomarkers in peripheral blood and tumor tissues
Time frame: Baseline to End of the Treatment assessed up to an average of 24 months