Phase 2
Completed N=100
Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL
Source: ClinicalTrials.gov NCT02564744 ↗Enrolled (actual)
100
Serious AEs
37.0%
Results posted
May 2024
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 16; 8; 12; 32 Participants
Summary
The primary purpose of the study was to determine the safety and tolerability, anti-tumor activity of the proposed Debio 1562 dose regimens in combination with rituximab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
16; 8; 12; 32; 29 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs |
6; 1; 2; 2; 2; 5 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs |
0; 0; 1; 0; 1; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs |
1; 0; 0; 1; 0; 0 | — |
| PRIMARY Objective Response Rate (ORR) |
26.7; 12.5; 81.8; 50.0; 50.0 | — |
| SECONDARY Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab |
10005.9; 9411.5; 11821.2; 15339.4; 6612.4; 8697.9 | — |
| SECONDARY Area Under the Time-concentration Curve From Time 0 to t (AUC0-t) of Debio 1562 and Rituximab |
— | — |
| SECONDARY Area Under the Time-concentration Curve From Time 0 to Infinity (AUC0-inf) of Debio 1562 and Rituximab |
— | — |
| SECONDARY Terminal Half-life (t1/2) of Debio 1562 and Rituximab |
— | — |
| SECONDARY Clearance (CL) of Debio 1562 and Rituximab |
— | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Debio 1562 and Rituximab |
— | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Debio 1562 and Rituximab |
— | — |
| SECONDARY Progression-free Survival (PFS) |
1.4; 1.8; 20.7; 5.1; 4.6 | — |
| SECONDARY Time to Response (TTR) |
1.4; 1.4; 1.4; 1.5; 1.5 | — |
| SECONDARY Duration of Response (DOR) |
NA; 2.6; NA; NA; 16.5 | — |
| SECONDARY Overall Survival (OS) |
30.0; 8.4; 34.3; NA; 17.3 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADA) for Debio 1562 |
13; 6; 10; 25; 20; 1 | — |
Eligibility Criteria
Inclusion Criteria
- For Part 1 of the study, participants must have histopathologically confirmed diagnosis of R/R, DLBCL, FL, MZL/MALT, MCL, or other Sponsor approved NHL subtypes according to the World Health Organization (WHO) classification 2008 for which standard measures do not exist or are no longer effective.
- For Part 2 and Part 3 of the study, participants must have histopathologically and clinically confirmed diagnosis of relapsed DLBCL. Participants will be considered to have a relapsed disease if they showed a duration of response of at least 24 weeks after their first line of therapy. The following participants with relapsed DLBCL will be enrolled:
- Participants who received only one line of previous therapy and achieved either complete response (CR) or partial response (PR) for at least 24 weeks (from the last day of the last cycle) after their first line of therapy, but are not eligible for high dose chemotherapy with autologous stem cell transplantation (HD-ASCT)
- Participants who received more than one line of previous therapy (including HD-ASCT), and have achieved a duration of response (CR or PR) of at least 8 weeks (from the last day of the last cycle) after their last line of therapy
- Participants must have evaluable or measurable disease in accordance with the International Working Group Guidelines for Lymphoma.
- Participants must have received at least one but no more than six prior treatment regimens. Prior treatment with an anti-cluster of differentiation 20 (anti-CD20) agent, either alone or in combination, is allowed.
- Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
- Participants who are Hepatitis B surface antigen positive (HBsAg+) (must be polymerase chain reaction (PCR) negative) who are taking antivirals, are allowed to enroll.
Exclusion Criteria
- Participants with a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- For Part 2 and Part 3 of the study, participants with primary refractory DLBCL (defined as progression of disease within 24 weeks after first line of treatment).
- For Part 2 and Part 3 of the study, participants that are eligible to undergo first time HD-ASCT.
- For Part 2 and Part 3 of the study, participants with R/R FL, MZL/MALT, MCL, or any other NHL subtypes according to the WHO classification.
- Participants with active hepatitis A, B or C infection.
- Women who are pregnant or breast feeding.
- Participants who have received prior therapy with other anti-CD37-targeting therapy.
- Participants who have known central nervous system, meningeal, or epidural disease including brain metastases.
- Participants with impaired cardiac function or clinically significant cardiac disease.
- Participants currently presenting interstitial lung disease, diffuse parenchymal lung disease, or with a past history of severe/Grade 3 parenchymal lung disorders.
Data sourced from ClinicalTrials.gov (NCT02564744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.