A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.

Conditions

• Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)
• Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ARV-393 — DRUG
  Oral daily dose of ARV-393 at a specified dose level
• Glofitamab — DRUG
  Glofitamab infusion per labelled prescribing information

Study Details

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.

Key Dates

Start date

Sep 5, 2024

Status verified

Feb 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

255 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A Monotherapy Dose escalation
  Participants with R/R NHL will receive ARV-393 dose escalation beginning at dose level 1
• Experimental: Part B Monotherapy: Dose expansion/optimization
  Dose expansion and optimization of ARV-393 will be conducted in Part B to determine the recommended phase 2 dose (RP2D) for participants with R/R NHL
• Experimental: Part C Combination therapy: Dose escalation
  Participants with R/R diffuse large B-cell lymphoma (DLBCL) will receive ARV-393 in combination with glofitamab, beginning at an ARV-393 dose informed by the Part A. Glofitamab will be given per labelled prescribing information. Part C will be conducted in non-USA centers.
• Experimental: Part D Combination therapy: Dose expansion/optimization
  Part D will be an optimization of ARV-393 in combination with glofitamab to determine a potential RP2D for ARV-393 in the combination regimen. Part D will be conducted in non-USA centers in participants with R/R DLBCL.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities During First 28 Days [ Time Frame: 28 days from first study dosing ]

Central Contacts

• Arvinas Operations, Inc.
  475-345-0791
  [email protected]

Locations (8)

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