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

NCT ID: NCT05354362

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-02-08

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.

Conditions

Relapsed/Refractory Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATG-010 and ATG-008

ATG-010 and ATG-008 should be taken 6 hours apart on a PK sampling day

Group Type: EXPERIMENTAL

ATG-010 and ATG-008

Intervention Type: COMBINATION_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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antengene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Yu

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The first Affiliated Hospital of China medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

ATG-008&010-DLBCL-001

Identifier Type: -

Identifier Source: org_study_id