Clinical Trials Directory

Trials / Terminated

TerminatedNCT05265975

A Study of ATG-010 in Combination With Lenalidomide and Rituximab (R2) in Adults With DLBCL and iNHL

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)

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Antengene Corporation · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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).

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DRUGATG-010Tablets,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
DRUGLenalidomideOral administration,QD, Days 1-21 of each cycle
DRUGRituximabIntravenous injection Days 1 of each cycle, Cycles 1-6

Timeline

Start date
2022-04-07
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2022-03-04
Last updated
2025-06-09

Locations

6 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05265975. Inclusion in this directory is not an endorsement.