Health TrialsbyHealthPanel

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

ConditionClear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorXencor, Inc.

About this trial

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

Subjects who have relapsed and refractory ccRCC, pRCC, NSCLC, and CRC with evidence of disease progression on standard-of-care therapies

ECOG performance status of 0 or 1.

All subjects must have adequate tumor sample available (slides or archival FFPE blocks)

Disqualifiers

Prior treatment with an investigational anti-ENPP3/CD203c therapy

History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy

Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.

Failure to recover from any clinically significant toxicity related to previous anticancer treatment

Trial design

Design model

Sequential

Treatments tested in this trial

  • XmAb819

    Biological/Vaccine

    Monoclonal Bispecific Antibody

Treatment groups

307 Participants
are divided into 1 treatment group
Group A: Dose Escalation and ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)

Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS

Time frame
28 days
2

Incidence of dose limiting toxicities (DLTs)

Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.

Time frame
28 days

Secondary outcomes

1

Measurement of Cmax

Peak plasma concentration (Cmax)

Time frame
56 days
2

Measurement of AUCtau

Area under the plasma concentration versus time curve (AUCtau)

Time frame
56 days
3

Objective Response rate

Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)

Time frame
42 days
4

Progression-free survival

Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)

Time frame
42 days

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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