A Phase 1, First-In-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of Xmab541 in Advanced Solid Tumors

Study on Safety and Tolerability of Investigational Medication in Advanced Solid Tumors (types of cancer that form solid masses)

N
Nabil Adra, MD

Primary Investigator

Recruiting
15 years - 100 years
All
Phase 1
3 participants needed
1 Location

Brief description of study

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:

IU Clinical Trials Office

Email: iutrials@iu.edu

Phone: (317) 278-5632

Detailed description of study

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

 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Endometrial Cancer, Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
  • Age: 15 years - 100 years
  • Gender: All

Key Inclusion Criteria:

  • Age ≥ 18 years. For subjects with GCTs, age ≥15 years
  • CLDN6+ tumor
  • Histological or cytological documentation of locally advanced, recurrent, or metastatic 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, and bone marrow function

Key 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
  • Have 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
  • Positive test for hepatitis C RNA
  • Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

This study investigates the safety and tolerability of an investigational medication in people with advanced solid tumors. Advanced solid tumors are cancers that have spread and are difficult to treat. The purpose of this study is to find out if the investigational medication is safe and to determine the best dose for future research.

Participants will receive the investigational medication either through a vein (intravenous) or under the skin (subcutaneous). The study will look at how the body processes the medication and its effects on tumors. Participants will be monitored closely for any side effects.

  • Who can participate: Adults aged 18 and older, or 15 and older with germ cell tumors, with specific types of advanced cancer may participate. Participants must have a CLDN6+ tumor and have tried standard treatments without success. They should have a life expectancy of at least 3 months and adequate organ function.
  • Study details: Participants will receive the investigational medication either intravenously or subcutaneously. The study will monitor how the body processes the medication and its effects on the tumors.
Updated on 19 Nov 2025. Study ID: CTO-XMAB541-01, 28154

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