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A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkin's Lymphoma

Cancer Categories

Hematologic (Blood Cancers)

Karmanos Trial ID

2024-047

NCT ID

NCT06393738

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Dipenkumar
Modi, M.D.
Oncology - Hematology, Oncology - Medical View Profile

Objective:

Primary Objectives:

To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule

Secondary Objectives:

To characterize the pharmacokinetic profile of ARV-393 in plasma
To assess the preliminary anti-tumor activity of ARV-393

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Eligibility

Eligibility

Inclusion Criteria:

Eligible participants aged ≥18 years.
Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy.
Participants must also have ≥1 measurable lesion at study entry
Eastern Cooperative Oncology Group performance status of 0 or 1,
Freshly biopsied or archival tumor tissue available,
Participants with adequate organ function,
Participants must accept and follow pregnancy prevention guidance.

Exclusion Criteria:

No prior allogeneic stem cell transplant or solid organ transplantation, Autologous stem cell transplant, must not have occurred ≤100 days, previous CAR T-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, prior to ARV-393 treatment initiation.
Participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices