A Single-arm, Phase Ⅰ/Ⅱ Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ATG-010 in Combination with Lenalidomide and Rituximab (R2) in Adult Patients with Relapsed/Refractory DLBCL and iNHL Who are Ineligible for High-dose Chemotherapy (HDC) or Autologous Stem Cell Transplant (A SCT).
A Single-arm, Phase Ⅰ/Ⅱ Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ATG-010 in Combination with Lenalidomide and Rituximab (R2) in Adult Patients with Relapsed/Refractory DLBCL and iNHL Who are Ineligible for High-dose Chemotherapy (HDC) or Autologous Stem Cell Transplant (ASCT).About 84 subjects are scheduled to be enrolled in the study,Maximum 24 (Dose Escalation Phase) and 60 (Dose Expansion Phase).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Tablets,20mg, once a week: dosage group 1:40mg/time, dosage group 2:60mg/time, dosage group 3:80mg/time The treatment period was 28 days. The drug was administered on day 1,8 and 15 of each cycle
Oral administration,QD, Days 1-21 of each cycle
Intravenous injection Days 1 of each cycle, Cycles 1-6
The Second Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
DLT
The occurrence of severe toxicities during the first cycle of systemic cancer therapy
Time frame: 28 days after administration
AE
Any adverse medical event that occurs after a patient or clinical trial subject receives a drug product, but is not necessarily related to the treatment.
Time frame: 28 days after administration
ORR
Percentage of subjects with PR, or CR
Time frame: One year after last patient first dose
PFS
Duration of time from the first dose of study drug until progression or death due to any cause
Time frame: One year after last patient first dose
DOR
Duration of time from first occurrence of CR or PR until the first date that disease
Time frame: One year after last patient first dose
OS
Duration of time from the first dose of study drug until death due to any cause
Time frame: One year after last patient first dose
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The first Affiliated Hospital of China medical University
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China