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

Phase 1

Terminated

• Conditions: Relapsed/Refractory Diffuse Large B-cell Lymphoma
• Interventions: Combination Product: ATG-010 and ATG-008

• Registration Number: NCT05354362
• Lead Sponsor: Antengene Corporation

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.

Study Timeline

• Study Start: 2022-03-02
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-04-29
• Status Verified: 2022-07
• Primary Completion: 2023-02-06
• Study Completion: 2023-02-08
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
MTD	the last patient on study has completed 12 months of follow-up	Maximum Tolerated Dose
RP2D	the last patient on study has completed 12 months of follow-up	Recommended Phase 2 Dose

Secondary Outcome Measures

Name	Time	Method
TTP	the last patient on study has completed 12 months of follow-up	Time To Progression
DOR	the last patient on study has completed 12 months of follow-up	Duration of Response
TTR	the last patient on study has completed 12 months of follow-up	Time To Response
ORR	the last patient on study has completed 12 months of follow-up	Overall Response Rate
PFS	the last patient on study has completed 12 months of follow-up	Progression Free Survival
OS	the last patient on study has completed 12 months of follow-up	Overall Survival

Trial Locations

Locations (6)

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, 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