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A First-in-human, Open-label, Phase 1 Study To Evaluate The Safety, Antitumor Activity, Pharmacokinetics, And Pharmacodynamics Of Subcutaneous SAR446523, An Anti-GPRC5D ADCC-enhanced Monoclonal Antibody, In Participants With Relapsed/Refractory Multiple Myeloma
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
This is a first-in-human study of SAR446523 conducted in patients with RRMM.
The study consists of two parts:
Dose escalation (Part A): In this part, up to 6 dose levels (DLs) of SAR446523 will be explored to determine the maximum administered dose (MAD), maximum tolerated dose (MTD), and recommended dose range (RDR) of 2 dose regimens which will be tested in the dose optimization part.
Dose optimization (Part B): In this part, participants will be randomly assigned in a 1:1 ratio using interactive response technology (IRT) to either one of the chosen dose regimens of SAR446523 (determined from data coming from Part A), to determine the optimal dose as the recommended phase 2 dose (RP2D) of SAR446523.
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A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab Or Zanubrutinib Alone) Vs. BCL-2 Inhibitor (Venetoclax) And Rituximab In Previously Untreated Waldenströmâ??s Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate the effects of ibrutinib and rituximab with or without venetoclax in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax with ibrutinib and rituximab with may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib and rituximab alone.
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A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab In Participants With Relapsed Or Refractory Multiple Myeloma After 1 To 3 Prior Lines Of Therapy, Including An Anti-CD38 Antibody And Lenalidomide
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.
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An Open-label Phase I/II Trial Of Venetoclax-Dexamethasone In Relapsed And/or Refractory T(11;14) Systemic Light-Chain Amyloidosis
Rochester, MN
The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.
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MC230817, Phase 1/2 Trial Of ABBV-383 For Patients With Relapsed Refractory Waldenström Macroglobulinemia
Rochester, MN
The purpose of this study is to determine the safety, maximum tolerated dose (MTD) and RP2D of ABBV-383 monotherapy for patients with RRWM and to determine VGPR or deeper response as the best response achieved with ABBV 383 within 12 cycles of initiation of therapy for patients with RRWM.
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