Health TrialsbyHealthPanel

Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors

ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorXencor, Inc.

About this trial

The primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug XmAb808 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 in combination with XmAb808 on participants' tumor outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

CLDN6+ tumor

Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin

Adequate Eastern Cooperative Oncology Group performance status

Disqualifiers

Prior exposure to a CLDN6 targeting immune cell engager

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • XmAb541

    Biological/Vaccine

    Monoclonal Bispecific Antibody

  • XmAb808

    Biological/Vaccine

    Monoclonal Bispecific Antibody

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Dose Escalation and Dose Expansion of XmAb541 and XmAb808Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events

Time frame
Day 1 to 2 years
2

Incidence of dose-limiting toxicities

Time frame
Day 1 to Day 43

Secondary outcomes

1

Measurement of Cmax

Peak Plasma Concentration

Time frame
Day 1 - 2 years
2

Measurement of area under curve (AUC)

Area under the plasma concentration versus time curve

Time frame
Day 1 to 2 years
3

Measurement of Ctrough

Plasma concentration before next dose

Time frame
Day 1 to 2 years
4

Objective Response Rate

Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging

Time frame
Day 1 to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xencor, Inc.

Lead sponsor

Source ClinicalTrials.gov
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