Relapsed/Refractory Diffuse Large B-cell LymphomaPhase 1MATCHNCT05354362
A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Phase 1 study testing ATG-010 and ATG-008 in people with Relapsed/Refractory Diffuse Large B-cell Lymphoma, run by Antengene Corporation at 6 sites in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Diffuse Large B-cell Lymphoma
- What is being tested?
- ATG-010 and ATG-008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesChina
- Study dates
- 2 Mar 2022to 8 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Hunan Cancer Hospital
Changsha, Hunan, 410029
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
The first Affiliated Hospital of China medical University
Shenyang, Liaoning, 110001
Hubei Cancer Hospital
Wuhan, Hubei, 430079
About this study
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)
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)
Read the 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.
- Being tested
- ATG-010 and ATG-008
- Keywords
- Lymphoma, Hodgkin's lymphoma , non-Hodgkin's lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-010 and ATG-008Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| ATG-010 and ATG-008 | Experimental | ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day Receives: Combination Product: ATG-010 and ATG-008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum Tolerated Dose
Measured: the last patient on study has completed 12 months of follow-up
RP2D
Recommended Phase 2 Dose
Measured: the last patient on study has completed 12 months of follow-up
Secondary outcomes (6)
ORR
Overall Response Rate
Measured: the last patient on study has completed 12 months of follow-up
PFS
Progression Free Survival
Measured: the last patient on study has completed 12 months of follow-up
DOR
Duration of Response
Measured: the last patient on study has completed 12 months of follow-up
OS
Overall Survival
Measured: the last patient on study has completed 12 months of follow-up
TTR
Time To Response
Measured: the last patient on study has completed 12 months of follow-up
TTP
Time To Progression
Measured: the last patient on study has completed 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start2 Mar 2022
- Primary completion6 Feb 2023
- Study completion8 Feb 2023
Why it stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antengene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Yu, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354362
- Sponsor's protocol ID
- ATG-008&010-DLBCL-001
- Acronym
- MATCH
- Status last verified
- Jul 2022
- First submitted
- 26 Apr 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05354362
- Acronym / sponsor ID
- MATCH / ATG-008&010-DLBCL-001
- Keywords
- Lymphoma, Hodgkin's lymphoma , non-Hodgkin's lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Antengene CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-010 and ATG-008 | Experimental | Combination Product: ATG-010 and ATG-008ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-010 and ATG-008Patients 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. | Combination product | ATG-010 and ATG-008 |
Primary outcome
MTD
Time frame: the last patient on study has completed 12 months of follow-up
Maximum Tolerated Dose
RP2D
Time frame: the last patient on study has completed 12 months of follow-up
Recommended Phase 2 Dose
6 secondary outcomes
ORR
Time frame: the last patient on study has completed 12 months of follow-up
PFS
Time frame: the last patient on study has completed 12 months of follow-up
DOR
Time frame: the last patient on study has completed 12 months of follow-up
OS
Time frame: the last patient on study has completed 12 months of follow-up
TTR
Time frame: the last patient on study has completed 12 months of follow-up
TTP
Time frame: the last patient on study has completed 12 months of follow-up
Results and safety
The study was stopped early (reason given: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Yu study director
Medical Monitor
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATG-010 and ATG-008 in people with Relapsed/Refractory Diffuse Large B-cell Lymphoma, run by Antengene Corporation at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: the last patient on study has completed 12 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.