A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (SEARCH)

An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
• Intervention / Treatment: Drug: ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle

Detailed Description

This is an open-label, single arm, and registered study. About 60 patients with relapsed/refractory DLBCL plan to be enrolled in about 10 study sites of the study. It is planned that at least 50% (~30 patients) will have the GCB subtype of DLBCL. Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. Patients should remain on the study treatment of ATG-010, until either PD or occurrence of unacceptable toxicity.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jasmine Sun, MD; Phone Number: 13701803117; Email: jasmine.sun@antengene.com
• Study Contact Backup: Name: Stacey Chen, MD; Email: stacey.chen@antengene.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Province Cancer Hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Chongqing Universtity Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
    • Wuhan, Hubei, China, 430000
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affilate Hospital with Nanjing Medical University
  • Jilin
    • Chang chun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116027
      • The Second Hospital of Dalian Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • TianJin Medical University Cancer Institute & Hospital
    • Tianjin, Tianjin, China, 300052
      • Tianjin blood research institute
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Cancer Hospital of the University of the Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patient must provide informed consent form (ICF) prior to the first screening procedure.
2. Age ≥18 years.
3. ECOG performance status of ≤ 2.
4. Patients should have estimated life expectancy of >3 months at study entry.
5. Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
6. Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL.
7. Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
8. Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014).
9. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue.

Exclusion Criteria:

1. Patients who are pregnant or lactating.
2. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma +NHL), or DLBCL transformed from diseases other than indolent NHL or Richter's.
3. Primary mediastinal (thymic) large B-cell lymphoma.
4. Known central nervous system lymphoma or meningeal involvement.
5. Patients whose most recent systemic anticancer therapy include radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids < 6 weeks prior to first dose of study drug.
6. Patients who have not recovered to Grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
7. Patients with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
8. Major surgery within 2 weeks of first dose of study treatment of ATG-010.
9. Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
10. Active hepatitis B virus or hepatitis C virus infection.
11. Known human immunodeficiency virus infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATG-010; Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.	Drug: ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle; Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.; Other Names: Selinexor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Percentage of subjects with PR, or CR	6 months after the last subject was enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOR	Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented	6 months after the last subject was enrolled
DCR	Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)	6 months after the last subject was enrolled
OS	Duration of time from the first dose of study drug until death due to any cause	6 months after the last subject was enrolled
PFS	Duration of time from the first dose of study drug until progression or death due to any cause	6 months after the last subject was enrolled

Collaborators and Investigators

• Sponsor: Antengene Corporation
• Investigators: Study Director: Bingshan Liu, MD, Medical Monitor

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: ATG-010-DLBCL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No