Trials / Recruiting
RecruitingNCT06393738
A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 255 (estimated)
- Sponsor
- Arvinas Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed/Refractory non-Hodgkin's lymphoma (R/R NHL) to determine if ARV-393 may be a possible treatment option. ARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.
Detailed description
This is an open-label, global, multi-center monotherapy and combination dose escalation and dose optimization study to evaluate safety, tolerability and preliminary efficacy of ARV-393. The study will evaluate the safety and tolerability in ascending doses of ARV-393 as monotherapy (A) and in combination with glofitamab (C), as well as determine the RP2D in the dose optimization parts (B for monotherapy) and in combination with glofitamab (D for combination therapy). The monotherapy portions of the study will include participants with R/R NHL. The combination therapy portions of the study with glofitamab will include participants with R/R DLBCL.
Conditions
- Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)
- Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARV-393 | Oral daily dose of ARV-393 at a specified dose level |
| DRUG | Glofitamab | Glofitamab infusion per labelled prescribing information |
Timeline
- Start date
- 2024-09-05
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
- First posted
- 2024-05-01
- Last updated
- 2026-02-10
Locations
17 sites across 4 countries: United States, Canada, Denmark, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06393738. Inclusion in this directory is not an endorsement.