2022年12月12日 · Primary objectives of this study are to assess safety, tolerability, and dose-limiting toxicities and to identify the maximum tolerated dose and/or recommended dose (RD) of plamotamab. Secondary objectives are preliminary anti-tumor activity and pharmacokinetics (PK)/pharmacodynamics.

Introduction: Plamotamab is a CD20 x CD3 bispecific antibody evaluated with intravenous (IV) and subcutaneous (SC) dosing separately in a multi-center, multi-stage Ph1 study (NCT02924402). P lamotamab administered IV with a step-up priming regimen was well tolerated and demonstrated clinical activity in heavily pretreated patients (pts) with ...

2022年11月15日 · In the dose-escalation phase of an ongoing first-in-human (FIH) Ph 1 study (XmAb13676-01; NCT02924402), plamotamab was well tolerated with manageable cytokine release syndrome (CRS) and demonstrated evidence of clinical activity in heavily pretreated patients (pts) with relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL) (Patel; ASH 2021).

The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas.

2021年12月12日 · The Phase 1 study of plamotamab was originally designed in two parts: Part A to establish an initial priming dose with fixed, weight-based dosing regimens and Part B to escalate dosing on administrations after the priming dose (doses between 80 and 360 mcg/kg).

2024年9月9日 · The Phase 1b portion of the study will select a priming and step-up dose regimen based on the regimen established in oncology, and will assess the initial safety, efficacy, and biomarkers of plamotamab in patients with MDR-RA. The selected dose regimen will then be evaluated in the randomized Phase 2a portion, with efficacy determined at week 24.

2024年11月5日 · Introduction: Plamotamab is a CD20 x CD3 bispecific antibody evaluated with intravenous (IV) and subcutaneous (SC) dosing separately in a multi-center, multi-stage Ph1 study (NCT02924402).

A Phase 1 Study of Plamotamab, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Non-Hodgkin’s Lymphoma: Recommended Dose Safety/Efficacy Update and Escalation Exposure-Response Analysis

2021年11月5日 · The primary objectives are to determine safety, tolerability, and the maximum tolerated dose (MTD) or recommended dose of plamotamab. Secondary objectives include preliminary anti-tumor activity and pharmacokinetics/pharmacodynamics of plamotamab.

a Phase 1, first-in-human, multiple-dose, dose-escalation study designed in 4 parts, using intravenous (IV) administration in Parts A, B and C, and subcutaneous (SC) administration in Part D.