Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XmAb541.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
Overview
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.
Interventions
- Biological XmAb541
Monoclonal bispecific antibody
Primary outcome measures
- Incidence of adverse events [Time frame: Day 1 to 2 years]
- Incidence of dose-limiting toxicities (DLTs) [Time frame: Day 1 to Day 28]
- Incidence of cytokine release syndrome (CRS) [Time frame: Day 1 to Day 28]
Secondary outcome measures (6)
- Measurement of Cmax [Time frame: Day 1 to 2 years]
- Measurement of area under curve (AUC) [Time frame: Day 1 to 1.4 years]
- Measurement of Ctrough [Time frame: Day 1 to 2 years]
- Objective Response Rate [Time frame: Day 1 to 2 years]
- Duration of Response [Time frame: Day 1 to 2 years]
- Changes in Circulating Tumor DNA (ctDNA) [Time frame: Day 1 to 4 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years. For US only: 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 resistant to previous treatment
- Adequate Eastern Cooperative Oncology Group performance status
- Life expectancy ≥ 3 months
- Adequate liver, kidney, and bone marrow function
Exclusion criteria
- 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
- Active hepatitis B or hepatitis C
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- City of Hope — Duarte
- Stanford — Palo Alto
- University of California — San Francisco
- Moffitt Cancer Center — Tampa
- Winship Cancer Institute, Emory University — Atlanta
- University of Chicago Medical Center — Chicago
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
- Karmanos Cancer Institute — Detroit
- … and 9 more centers
Denmark · 1 center
- Herlev Gentofte Hospital — Herlev
Identifiers
NCT: NCT06276491 · XmAb541-01