A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma

A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01677390

Enrollment

Registered

2012-09-03

Start date

2012-08-31

Completion date

2013-12-31

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

Antibody-Drug Conjugate, monomethylauristatin F, Carcinoma, Renal Cell, Antigens, CD70, Drug Therapy

Brief summary

This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.

Interventions

DRUGSGN-75

1-2 mg/kg IV every 21 days

DRUGeverolimus

10 mg PO daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression * Previously treated with at least 1 tyrosine kinase inhibitor (TKI) * Measurable disease * Eastern Cooperative Oncology Group performance status 0 or 1 * Adequate lung and renal function

Exclusion criteria

* Prior treatment with anti-CD70-directed therapy * Received more than one prior treatment with an mTOR inhibitor

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and laboratory abnormalities	Through 1 month post last dose

Secondary

Measure	Time frame
Best clinical response according to RECIST Version 1.1	Through 1 month post last dose
Progression-free survival	Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival	Until death or study closure, an expected average of 1 year
Blood concentrations of SGN-75 and metabolites	Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Incidence of antitherapeutic antibodies	Pre-dose in most cycles and 1 month post last dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026