XmAb541-01

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

Open
Grade
High grade
Prior lines
1, 2, 3, 4, >4
Histology
Serous
Platin
Platinum resistant
Secondary platinum refractory
Phase
I
IMP
XmAb541
principal investigator
Prof. Dr. Toon Van Gorp (AT)

Treatment

XmAb541

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

 

Eligibility
 

Main inclusion criteria:

  • 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

 

Main exclusion criteria:

  • Participants with untreated brain metastases are excluded. Participants 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

 

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06276491). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact
 

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be