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A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb®541 in Advanced Solid Tumors

Cancer Categories

Gastrointestinal (GI),Gynecologic,Lung

Karmanos Trial ID

2024-013

NCT ID

NCT06276491

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Ira
Winer, M.D., Ph.D., FACOG
Oncology - Gynecologic, Oncology - Surgical View Profile

Objective:

Primary Objectives:

To assess the safety and tolerability of study drug
To identify the recommended dose(s) (RD[s]) and schedule(s) that is (are) safe and biologically effective for study drug administered by intravenous (IV) dosing
To identify the RD(s) and schedule(s) that is (are) safe and biologically effective for study drug administered by subcutaneous (SC) dosing

Secondary Objectives:

To characterize the pharmacokinetics (PK) of study drug administered by IV dosing
To characterize the PK of study drug administered by SC dosing
To assess the preliminary antitumor activity of study drug

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Eligibility

Eligibility

Inclusion Criteria:

Age ≥ 18 years. For subjects with GCTs, age ≥15 years
CLDN6+ tumor
Histological evidence of locally advanced, recurrent, or metastatic solid malignancy Ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT
Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.
Eastern Cooperative Oncology Group performance status of 0-2
Life expectancy ≥ 3 months
Adequate liver, kidney, thyroid and bone marrow function

Exclusion Criteria:

Prior exposure to a CLDN6 targeting product
Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.
Active known or suspected autoimmune disease
Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
Clinically significant cardiovascular, pulmonary or gastrointestinal disease
Known Human immunodeficiency virus (HIV) positivity
Positive test for hepatitis C RNA
Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

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