A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Relapsed/Refractory Diffuse Large B-cell Lymphoma Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05354362
• Other study ID #: ATG-008&010-DLBCL-001
• Status: Terminated
• Phase: Phase 1
• Start date: March 2, 2022
• Est. completion date: February 8, 2023

Study information

• Verified date: July 2022
• Source: Antengene Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: February 8, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years old.

2. ECOG Performance score of =2.

3. Estimated life expectancy of >3 months.

4. Previously treated, pathologically confirmed DLBCL

5. 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.

1. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.

2. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy.

3. Any maintenance therapy will not be counted as a separate line of systemic therapy.

4. Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy

6. Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.

Exclusion Criteria:

1. Female patients who are pregnant or lactating

2. DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL)

3. Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered).

4. Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility)

5. 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.

6. Autologous stem cell transplant (SCT) <6 months or prior allogeneic SCT, or CAR-T cell infusion <6 months prior to Cycle 1.

7. Major surgery within 4 weeks of the first dose of study treatment.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Relapsed/Refractory Diffuse Large B-cell Lymphoma

Intervention

Combination Product:
• ATG-010 and ATG-008
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.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The first Affiliated Hospital of China medical University	Shenyang	Liaoning
China	Hubei Cancer Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Antengene Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	Maximum Tolerated Dose	the last patient on study has completed 12 months of follow-up
Primary	RP2D	Recommended Phase 2 Dose	the last patient on study has completed 12 months of follow-up
Secondary	ORR	Overall Response Rate	the last patient on study has completed 12 months of follow-up
Secondary	PFS	Progression Free Survival	the last patient on study has completed 12 months of follow-up
Secondary	DOR	Duration of Response	the last patient on study has completed 12 months of follow-up
Secondary	OS	Overall Survival	the last patient on study has completed 12 months of follow-up
Secondary	TTR	Time To Response	the last patient on study has completed 12 months of follow-up
Secondary	TTP	Time To Progression	the last patient on study has completed 12 months of follow-up