A Phase 1 interventional study of MAK683 in Diffuse Large B-cell Lymphoma, sponsored by Novartis Pharmaceuticals. Terminated at 16 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.
The purpose phase I of this trial is to characterize safety and tolerability and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MAK683.
The purpose of the phase II of this trial is to evaluate the anti-tumor activity of MAK683. Phase II part will not be opened.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's enrollment of 139 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1) Insufficient bone marrow function at screening:
advanced stage (relapsed/refractory or recurrent/metastatic) malignancy limited to the following malignancies; DLBCL, nasopharyngeal carcinoma, gastric cancer, ovarian cancer, prostate cancer and sarcoma.
Drug: MAK683
Drug: MAK683
Incidence of dose limiting toxicities (DLTs)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 28 days
Safety and tolerability
Incidence and severity of AEs, SAEs, changes in laboratory values, vital signs and ECGs, dose interruptions and reductions
Time frame: up to approximately 3 years
Overall Response Rate (ORR)
Time frame: up to 30 months
Duration of overall response (DOR)
Time frame: up to 30 months
Progression-free survival (PFS)
Time frame: up to 30 months
Best Overall Response (BOR)
Time frame: up to 30 months
Peak Plasma Concentration (Cmax) of MAK683
Pharmacokinetic profile of MAK683
Time frame: 30 months
Area Under the Plasma Concentration (AUC) Time Curve of MAK683
Pharmacokinetic profile of MAK683
Time frame: 30 months
Half-Life of MAK683
Pharmacokinetic profile of MAK683
Time frame: 30 months
H3K27 tri methylation level in PBMC
Cycle 1 Day 1,8,15 Cycle 2 Day1 Cycle 3 Day 1 End of treatment (EOT); Disease progression PBMC: peripheral blood mononuclear cell
Time frame: up to day 15
Plan to share: No — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Lymphoma, Large B-Cell, Diffuse→
Novartis Pharmaceuticals