For Healthcare Professionals

Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


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:

  1. Platelets ≤ 50,000/mm3
  2. Hemoglobin (Hgb) ≤ 80 g/L
  3. Absolute neutrophil count (ANC) ≤ 1000/mm3 2) Insufficient hepatic and renal function at screening:
  4. ALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases)
  5. Total bilirubin >1.5 x ULN
  6. Serum creatinine > 1.5 x ULN and/or creatinine clearance ≤ 50 mL/min

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Diffuse Large B-cell Lymphoma

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Jul 26, 2024

Treatment type



Novartis identifier


Study number


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