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

NCT05354362 | Terminated Phase 1

• 1 other identifier: ATG-008&010-DLBCL-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 6

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)

Conditions

Relapsed/Refractory Diffuse Large B-cell Lymphoma

Keywords

Lymphoma, Hodgkin's lymphoma , non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (2)

• MTD

  Maximum Tolerated Dose

  the last patient on study has completed 12 months of follow-up

• RP2D

  Recommended Phase 2 Dose

  the last patient on study has completed 12 months of follow-up

Secondary Outcomes (6)

• ORR

  the last patient on study has completed 12 months of follow-up

• PFS

  the last patient on study has completed 12 months of follow-up

• DOR

  the last patient on study has completed 12 months of follow-up

• OS

  the last patient on study has completed 12 months of follow-up

• TTR

  the last patient on study has completed 12 months of follow-up

Study Arms (1)

ATG-010 and ATG-008

EXPERIMENTAL

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

Combination Product: ATG-010 and ATG-008

Interventions

ATG-010 and ATG-008 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.

ATG-010 and ATG-008

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antengene Corporation: lead

Study Sites (6)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410029, China

Location

The first Affiliated Hospital of China medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yang Yu

  Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: March 2, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 8, 2023
• Last Updated: March 17, 2023

Record last verified: 2022-07

Locations

CN (6)