Recruiting
Phase 1

ARV-393

Sponsor:

Arvinas Inc.

Code:

NCT06393738

Conditions

Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)

Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARV-393

Glofitamab

Study Details

Brief 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.

Conditions

Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)

Relapsed/Refractory (R/R) Angioimmunoblastic T-cell Lymphoma (AITL)

Study ID

NCT06393738

Start date

Sep 5, 2024

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • For Part A and B: Have relapsed/refractory NHL and >=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy.
  • For Part C and D: Have R/R DLBCL, not otherwise specified \[NOS (DLBCL, NOS)\] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.
  • Have at least one bi dimensionally measurable lesion >1.5-centimeter (cm) in largest dimension for nodal or >1.0 cm for extranodal lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma).
  • Adequate bone marrow function
  • Adequate kidney function
  • Adequate Liver Function

Exclusion Criteria:

  • Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS), except for peripheral eosinophilia due to disease under study. Participants with current or prior eosinophilia requiring systemic steroid treatment are excluded regardless of etiology.
  • Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
  • Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 60 days prior to Cycle 1 Day 1 (C1D1) or any prior treatment with a BCL6-targeted therapy
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance.
  • Any of the following in the previous 6 months:

  • Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes;
  • Clinically important atrial or ventricular arrhythmias;
  • Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV;
  • Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episode of thromboembolic disease;
  • Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery.
  • Uncontrolled hypertension despite optimal medical treatment
  • History of myocarditis.
  • In ability to comply with listed prohibited treatments.
  • Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Cardiac ejection fraction <45%.

Study Design

Enrollment

329 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ARV-393

Oral daily dose of ARV-393 at a specified dose level

Glofitamab

Glofitamab infusion per labelled prescribing information

Primary outcome measure

  • Incidence of Dose Limiting Toxicities During First 28 Days [ Time Frame: 28 days from first study dosing ]
  • Percentage of Participants With Adverse Events Characterized by Severity, Seriousness, and Relationship to Study Drug as a Measure of Safety and Tolerability [ Time Frame: Parts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393 ]
  • Number of Participants With Abnormal Vital Signs, Abnormal ECG Readings (QT Interval) and Abnormal Laboratory Parameters [ Time Frame: Parts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393 ]
  • Percentage of Participants With Grade 3 or Grade 4 Clinical Lab Abnormalities Using the Common Terminology Criteria for Adverse Events (CTCAE) With Scale From Grade 1 Grade 5. Higher Score Means Worse Outcome [ Time Frame: Parts A and B: From the study baseline to 30 days after last dose of ARV-393; Parts C and D: From the study baseline to 40 days after last dose of ARV-393 ]

Central Contacts and Locations

Central contacts

Arvinas Operations, Inc.

475-345-0791clinicaltrialsARV-393@arvinas.com

Locations

Clinical Trial Site

Recruiting

New Haven, Connecticut, United States, 06510

Clinical Trial Site

Recruiting

Miami, Florida, United States, 33136

Clinical Trial Site

Recruiting

Detroit, Michigan, United States, 48201

Clinical Trial Site

Recruiting

New Brunswick, New Jersey, United States, 10065

Clinical Trial Site

Recruiting

New York, New York, United States, 10016

Clinical Trial Site

Recruiting

New York, New York, United States, 10021

Clinical Trial Site

Recruiting

Cleveland, Ohio, United States, 44122

Clinical Trial Site

Recruiting

Houston, Texas, United States, 77030

Clinical Trial Site

Recruiting

Charlottesville, Virginia, United States, 22908

Clinical Trial SIte

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Clinical Trial Site

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

Clinical Trial Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Arvinas Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Relapsed/Refractory B cell Non Hodgkin Lymphoma (NHL)
  • Relapsed/Refractory Angioimmunoblastic T-cell lymphoma (AITL)
  • Advanced non-Hodgkin Lymphoma
  • advanced NHL
  • relapsed non-Hodgkin Lymphoma
  • refractory non-Hodgkin Lymphoma
  • B Cell Advanced Non-Hodgkin Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arvinas Inc. on 2026-09-04.