A Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    86
  • sponsor
    Novartis Pharmaceuticals
Updated on 18 October 2022

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.

Description

The primary objective of the study is to evaluate the safety and tolerability in patients with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of VAY736 single agent and in combination with other anti-cancer therapies.

This is a phase I/Ib, multi-center, open-label study with multiple treatment arms in an adaptive study design. The study is comprised of a dose escalation part and dose expansion part.

In dose escalation, the investigational drug VAY736 will be explored alone or in combination with partner therapies. Increasing doses of VAY736 alone or in combination will be given to small groups of patients to identify the MTD/RD in patients with NHL. In dose expansion, some or all the treatments from dose escalation will be tested at the recommended doses in patients with NHL. The initial combination partner is lenalidomide. Other combination partners may be added in the future by protocol amendment. The study is expected to be approximately 4 years in duration (from enrollment of first patient to discontinuation of last patient).

Details
Condition Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Treatment Lenalidomide, VAY736
Clinical Study IdentifierNCT04903197
SponsorNovartis Pharmaceuticals
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must have confirmed diagnosis of relapsed/refractory DLBCL
Received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-CD20 therapy, but no more than 5 prior lines)
Must have measurable disease and ECOG of 0 to 2
Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy and be willing to undergo study required biopsies at screening and during therapy

Exclusion Criteria

Baseline laboratory results outside of protocol defined ranges
Presence of history of central nervous system involvement by lymphoma
History of hypersensitivity to VAY736 or any drugs in similar chemical classes (e.g. monoclonal antibodies)
Impaired cardiac function or clinically significant cardiac disease
History of or current interstitial lung disease or pneumonitis grade 2 or higher
HIV infection
Active hepatitis C infection and/or hepatitis B infection
Pregnant or nursing (lactating) women
Women of child-bearing potential unless they are using highly effective methods of contraception
Other Inclusion/Exclusion criteria may apply
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