The primary objective of Phase I of this study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas. The primary objective of Phase II of this study is to evaluate the efficacy of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
The primary objective of Phase I of this study is to evaluate the safety, tolerability, PK, PD and efficacy to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of CTS3497 in patients with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deficient solid tumors and lymphomas. The primary objective of Phase II of this study is to evaluate the efficacy and safety of CTS3497 in patients with metastatic or locally advanced MTAP-deficient solid tumors and lymphomas.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
CTS3497: Orally via capsules
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPhase I: Number of Patients Who Experience a Dose-Limiting Toxicity (DLT)
Incidence of DLT(s) during the DLT observation period
Time frame: Up to 21 days after the first administration.
Phase I: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs. Serious AEs (SAEs) are defined as any event that meets at least 1 of the following criteria: resulting in death (fatal); requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability/incapacity; being a congenital anomaly/birth defect; other medically important serious event.
Time frame: Baseline through 28 days after the end of treatment, estimated up to 52 weeks.
Phase II: Objective Response Rate (ORR)
The percentage of participants having complete response (CR) or partial response (PR) assessed based on RECIST V1.1.
Time frame: up to 48 weeks.
Cmax of CTS3497
Maximal Plasma Concentration
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
Tmax of CTS3497
Time to Achieve Maximal Plasma Concentration
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
AUC of CTS3497
Area Under the Plasma Concentration Versus Time Curve
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1
Disease control rate (DCR)
Disease Control Rate assessed by investigators based on RECIST v1.1
Time frame: up to 48 weeks.
Duration of Response (DoR)
Duration of response (DOR) assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
Time frame: Estimated up to 48 weeks.
Progression-Free Survival (PFS)
Progression-Free Survival assessed by investigators based RECIST v1.1
Time frame: Estimated up to 48 weeks.
Overall Survival (OS)
Overall Survival after first dose
Time frame: Up to approximately 3 years.
Pharmacodynamic (PD) characteristics of CTS3497: symmetric dimethylarginine (SDMA)
To explore the changes of symmetric dimethylarginine (SDMA) in blood of patients with solid tumors and lymphomas before and after administration of CTS3497.
Time frame: Cycle 1 (each cycle is 21 days) Day 1, Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 5 Day 1 and Cycle 7 Day 1
Pharmacodynamic (PD) characteristics and efficacy analysis.
The correlation between the changes of symmetric dimethylarginine (SDMA) in blood of patients and the efficacy of CTS3497
Time frame: Estimated up to 48 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.