Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Drug: Docetaxel - administered intravenously

Drug: vantictumab - administered intravenously

Vantictumab will be administered intravenously

vantictumab

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with docetaxel.

Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with docetaxel. Up to approximately 34 patients may be enrolled into the study.

A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC

A Phase 1b Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer

Apparent half life, AUC, clearance, volume of distribution

OncoMed Pharmaceuticals, Inc.

OMP-59R5

David C. Smith, MD

Anthony W. Tolcher, MD

This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.

Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-59R5 every week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in \<2 of the 6 subjects experiencing a DLT.

A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors

A Phase 1 Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors

The number of patients experiencing Adverse Events will be reported.

The half-life, volume of distribution, and clearance will be determined

The rate of neutralizing antibodies will be determined

The response outcome in patient will be determined

IV infusion. Subjects with stable disease or a response at Day 56 will be allowed to continue until disease progression.

OMP-18R5

This is an open-label Phase 1 dose escalation study of OMP-18R5 in subjects with a solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.

Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-18R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-18R5 every week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-18R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in \< 2 of the 6 subjects experiencing a Grade 3 (not including a Grade 3 infusion reaction that resolves in 24 hours) or 4 adverse event (DLT).

A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors

A Phase 1 Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors

The half-life, volume of distribution, and clearance will be determined.

The response outcome in patients will be determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC	NCT01957007	Solid Tumors	Docetaxel vantictumab	18 Years - 90 Years	Mereo BioPharma
A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors	NCT01277146	Solid Tumors	OMP-59R5	18 Years - 90 Years	Mereo BioPharma
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors	NCT01345201	Solid Tumors	OMP-18R5	18 Years - 90 Years	Mereo BioPharma
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors	NCT01345201	Solid Tumors	OMP-18R5	18 Years - 90 Years	Mereo BioPharma
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors	NCT01345201	Solid Tumors	OMP-18R5	18 Years - 90 Years	Mereo BioPharma

Spots Global Cancer Trial Database for malignancy metastatic