Clinical trial · Interventional
Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies
A Phase I/II, Multicenter, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The decision of early termination was made due to business reasons, and was not based on any safety or tolerability concerns for MAK683
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAK683 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase I - All
- description
- advanced stage (relapsed/refractory or recurrent/metastatic) malignancy limited to the following malignancies; DLBCL, nasopharyngeal carcinoma, gastric cancer, ovarian cancer, prostate cancer and sarcoma.
- interventionNames
- Drug: MAK683
Primary outcomes (2)
- measure
- Incidence of dose limiting toxicities (DLTs)
- timeFrame
- up to 28 days
- description
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
- measure
- Safety and tolerability
- timeFrame
- up to approximately 3 years
- description
- Incidence and severity of AEs, SAEs, changes in laboratory values, vital signs and ECGs, dose interruptions and reductions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG): 0 to 2 2. Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014) 3. Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1. Exclusion Criteria: 1. Other malignant diseases than the ones being treated in this study 2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result. 3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant 4. Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment 5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control. 6. Patient having out of range laboratory values defined as: 1\) Insufficient bone marrow function at screening: * Platelets ≤ 50,000/mm3 * Hemoglobin (Hgb) ≤ 80 g/L * Absolute neutrophil count (ANC) ≤ 1000/mm3 2) Insufficient hepatic and renal function at screening: * ALP, ALT, and AST \> 3 x ULN (\>5 x ULN if subject has liver metastases) * Total bilirubin \>1.5 x ULN * Serum creatinine \> 1.5 x ULN and/or creatinine clearance ≤ 50 mL/min
References
Publications (1)
- DERIVEDRibrag V, Iglesias L, De Braud F, Ma B, Yokota T, Zander T, Spreafico A, Subbiah V, Illert AL, Tan D, Santoro A, Munster PN, Suehiro Y, Wang Y, Ji DM, Chen S, Beltz K, Suenaga N, Ramkumar T, Luo F, Lai C, Wainberg ZA. A first-in-human phase 1/2 dose-escalation study of MAK683 (EED inhibitor) in patients with advanced malignancies. Eur J Cancer. 2025 Feb 5;216:115122. doi: 10.1016/j.ejca.2024.115122. Epub 2024 Nov 16. PMID 39793445