Back to resultsA Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (MATCH)
Primary Purpose
Relapsed/Refractory Diffuse Large B-cell Lymphoma
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ATG-010 and ATG-008
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Diffuse Large B-cell Lymphoma focused on measuring Lymphoma, Hodgkin's lymphoma , non-Hodgkin's lymphoma
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old.
- ECOG Performance score of ≤2.
- Estimated life expectancy of >3 months.
- Previously treated, pathologically confirmed DLBCL
Patients must have received at least 2 but no more than 5 previous systemic regimens (for non-DH/TH, non-DE DLBCL and DLBCL not transformed from FL or CLL), or at least 1 but no more than 5 previous systemic regimens (for DH/TH, DE DLBCL, and DLBCL transformed from FL or CLL) for the treatment of their DLBCL.
- Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
- Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy.
- Any maintenance therapy will not be counted as a separate line of systemic therapy.
- Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy
- Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.
Exclusion Criteria:
- Female patients who are pregnant or lactating
- DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL)
- Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered).
- Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility)
- Use of any standard or experimental anti-DLBCL therapy (including radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to Cycle 1 Day 1.
- Autologous stem cell transplant (SCT) <6 months or prior allogeneic SCT, or CAR-T cell infusion <6 months prior to Cycle 1.
- Major surgery within 4 weeks of the first dose of study treatment.
Sites / Locations
- Chongqing Cancer Hospital
- Sun Yat-sen University Cancer Center
- Guangzhou First People's Hospital
- Hubei Cancer Hospital
- Hunan Cancer Hospital
- The first Affiliated Hospital of China medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATG-010 and ATG-008
Arm Description
ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day
Outcomes
Primary Outcome Measures
MTD
Maximum Tolerated Dose
RP2D
Recommended Phase 2 Dose
Secondary Outcome Measures
ORR
Overall Response Rate
PFS
Progression Free Survival
DOR
Duration of Response
OS
Overall Survival
TTR
Time To Response
TTP
Time To Progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05354362
Brief Title
A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Acronym
MATCH
Official Title
An Open Label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antengene Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an Open label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
Detailed Description
This is a multi-center, open label, phase 1 study conducted in RR DLBCL patients. The MTD and/or RP2D of study treatment, ATG-010 in combination with ATG-008, will be selected using BOIN design for the dose escalation phase. Additional patients will be enrolled as an expansion cohort after MTD and/or RP2D is determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Diffuse Large B-cell Lymphoma
Keywords
Lymphoma, Hodgkin's lymphoma , non-Hodgkin's lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATG-010 and ATG-008
Arm Type
Experimental
Arm Description
ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day
Intervention Type
Combination Product
Intervention Name(s)
ATG-010 and ATG-008
Intervention Description
Patients enrolled will receive consecutive daily treatment at assigned dose level. The starting dose of ATG-010 at the dose escalation phase will be 60 mg QW, which could be escalated to 80 mg QW, 100 mg QW, 60 mg BIW. In case 60 mg QW of ATG-010 with any dose of ATG-008 is NOT tolerable, 40 mg QW ATG-010 could be explored. The starting dose of ATG-008 will be 15 mg QD, which could be escalated to 20 mg QD, with maximum of 30 mg QD. SRC will be consulted before each dose escalation starts.
Primary Outcome Measure Information:
Title
MTD
Description
Maximum Tolerated Dose
Time Frame
the last patient on study has completed 12 months of follow-up
Title
RP2D
Description
Recommended Phase 2 Dose
Time Frame
the last patient on study has completed 12 months of follow-up
Secondary Outcome Measure Information:
Title
ORR
Description
Overall Response Rate
Time Frame
the last patient on study has completed 12 months of follow-up
Title
PFS
Description
Progression Free Survival
Time Frame
the last patient on study has completed 12 months of follow-up
Title
DOR
Description
Duration of Response
Time Frame
the last patient on study has completed 12 months of follow-up
Title
OS
Description
Overall Survival
Time Frame
the last patient on study has completed 12 months of follow-up
Title
TTR
Description
Time To Response
Time Frame
the last patient on study has completed 12 months of follow-up
Title
TTP
Description
Time To Progression
Time Frame
the last patient on study has completed 12 months of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years old.
ECOG Performance score of ≤2.
Estimated life expectancy of >3 months.
Previously treated, pathologically confirmed DLBCL
Patients must have received at least 2 but no more than 5 previous systemic regimens (for non-DH/TH, non-DE DLBCL and DLBCL not transformed from FL or CLL), or at least 1 but no more than 5 previous systemic regimens (for DH/TH, DE DLBCL, and DLBCL transformed from FL or CLL) for the treatment of their DLBCL.
Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy.
Any maintenance therapy will not be counted as a separate line of systemic therapy.
Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy
Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.
Exclusion Criteria:
Female patients who are pregnant or lactating
DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL)
Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered).
Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility)
Use of any standard or experimental anti-DLBCL therapy (including radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to Cycle 1 Day 1.
Autologous stem cell transplant (SCT) <6 months or prior allogeneic SCT, or CAR-T cell infusion <6 months prior to Cycle 1.
Major surgery within 4 weeks of the first dose of study treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Yu
Organizational Affiliation
Medical Monitor
Official's Role
Study Director
Facility Information:
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410029
Country
China
Facility Name
The first Affiliated Hospital of China medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
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