Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Antibodies

Lenalidomide

Pomalidomide

Antibodies, Bispecific

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

OT-A201 administered by IV infusion on a weekly (qw) basis. An alternative dosing schedule of every 2 weeks (q2w) may be implemented based on the clinical safety and laboratory data.

OT-A201 in combination with lenalidomide or pomalidomide at the approved dose

OT-A201 in combination with late stage approved treatment (combination to be defined by a protocol amendment)

OT-A201 in combination with bevacizumab at the approved dose

OT-A201 in combination with paclitaxel at the approved dose

OT-A201

Combination regimen for hematological malignancy Lenalidomide: 25 mg on Days 1 to 21 of each 28-day cycle; or Pomalidomide: 4 mg on Days 1 to 21 of each 28-day cycle

IMids

Combination regimen for solid tumor Bevacizumab: 10 mg/m² q2w

Combination regimen for solid tumor Paclitaxel: 175 mg/m² q3w

Combination regimen for hematological malignancy

TBD Compound

Bruno Piccolella

Erica Wang

Jérémy Fleith

Diego Tosi, MD

Cécile Popko

Guillaume Cartron, MD, PhD

Sandrine Rullé

Eric Raymond, MD, PhD

Emilie Fouchet

Héloise Bourien, MD

This phase 1 study is aimed at establishing the safety basis of OT-A201 in the treatment of hematological malignancies and solid tumors. In the dose of escalation part it is to characterize the overall safety and tolerability profile and determine the recommended dose(s) of OT-A201 as monotherapy, and in various combination regimens. Preliminary information about anti-cancer activity will be further explored in the expansion part of the study.

Monotherapy dose escalation followed by dose confirmation of combination regimens.

Further expansion of each groups.

First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

A First-in-human, Dose-escalation Followed by Expansion Study to Assess the Safety and Preliminary Efficacy of a Bispecific Antibody OT-A201 as Monotherapy and in Combination Therapy in Patients With Selected Hematological Malignancies and Solid Tumors

Evaluate dose-limiting toxicity (DLT) during the DLT observation period

Incidence, severity, and relationship of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs leading to discontinuation of study treatment; and clinically significant findings on clinical laboratory tests, vital signs, ECGs, and physical examinations

Onward Therapeutics

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Prednisone

Melphalan

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Induction (4 cycles):Lenalidomide 25 mg/die for 21 days followed by a 7 days rest period and Prednisone at 50 mg three times a week continuously . Consolidation (6 cycles): Melphalan 2 mg three times a week, Prednisone 50 mg three times a week, and Lenalidomide 15 mg/die for 21 days followed by a 7 days rest period. According to the results of the first stage the decisions are as follows: 1. Starting a second stage, at the same dose of lenalidomide for MPR cycles, if grade 3-4 adverse events are 25-50% and PR \> 50%; 2. The study stop (if PR \<40% and grade 3-4 adverse events \>25-30%) 3. A new first stage may be started: - Lenalidomide 20 mg/die if grade 3-4 adverse events are \< 25-30%, independently from efficacy; - Lenalidomide 10 mg/die if grade 3-4 adverse events are \> 50% and PR rate \> 50%. Maintenance: Lenalidomide 10 mg/day from day 1 to 21, followed by a 7-day rest period and Prednisone 25 mg three times a week.Each cycle will be repeated every 28 days, until PD.

RP followed by MPR

Mario Boccadoro, MD

This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.

This phase II study is a multicenter, open label trial designed to determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.

This study consists of 3 phases for each study subject: Pre-treatment, Treatment, long-term follow-up (LTFU).

Pre-treatment period: after providing written informed consent, patients will undergo screening for protocol eligibility as outlined in the Schedule of Study Assessments.

Treatment period: includes induction, consolidation and maintenance.

Induction regimen:Patients will start induction treatment with association of Lenalidomide and Prednisone (RP).

Consolidation regimen After the completion of the 4 RP cycles therapy will continue with the MPR association:·

According to the results after the first stage the decisions are as follows: 1. The study may continue to a second stage, at the same dose of lenalidomide of MPR cycles, if grade 3-4 adverse events are 25-50% and PR \> 50%;

2. The study may be stopped (if PR \< 40% and grade 3-4 adverse events \> 25-30%)

3. A new first stage may be started:

* At an increase dose of Lenalidomide administered in advanced MPR cycles if grade 3-4 adverse events are \< 25-30%, independently from efficacy;
* At a reduced dose of Lenalidomide administered in advanced MPR cycles if grade 3-4 adverse events are \> 50% and PR rate \> 50%

Maintenance: Within 3 months from the last MPR cycle, therapy will continue with RP as maintenance.

Each cycle will be repeated every 28 days, until PD.

Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients

A Multicenter, Open Label Study Of Oral Revlimid And Prednisone (Rp) Followed By Oral Revlimid Melphalan And Prednisone (Mpr) In Newly Diagnosed Elderly Multiple Myeloma Patients

Determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.

The secondary objectives of this study are:

* To determine progression free survival (PFS)
* To determine overall survival (OS)
* To determine whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors	NCT05828459	Hematological M... Solid Tumor	OT-A201 IMids Bevacizumab Paclitaxel TBD Compound	18 Years -	Onward Therapeutics
First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors	NCT05828459	Hematological M... Solid Tumor	OT-A201 IMids Bevacizumab Paclitaxel TBD Compound	18 Years -	Onward Therapeutics
Revlimid And Prednisone Followed By Revlimid, Melphalan And Prednisone In Multiple Myeloma Patients	NCT01160107	Multiple Myelom...	RP followed by ...	65 Years - 100 Years	Fondazione EMN Italy Onlus

Spots Global Cancer Trial Database for imids

Every month we try and update this database with for imids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imids

Every month we try and update this database with for imids cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.