Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 24, 2017

Primary Completion Date

December 1, 2021

Study Completion Date

December 2, 2021

Conditions
Ewing SarcomaPEComaEpithelioid SarcomaDesmoid TumorChordomaNon Small Cell Lung CancerUrothelial CarcinomaMelanomaRenal Cell CarcinomaSquamous Cell CarcinomaHepatocellular CarcinomaClassical Hodgkin LymphomaColorectal CancerMTOR Activating Mutation
Interventions
DRUG

Nab-Rapamycin

Escalating doses of ABI-009 will be given IV over 30 min for 2 of every 3 weeks beginning Day 8 Cycle 2. Only nivolumab will be given in Cycle 1. At Dose Level 1, 3-6 patients will receive 56 mg/m\^2; at Dose Level 2, 3-6 six patients will receive 75 mg/m\^2; and at Dose Level 3, 3-6 patients will receive 100 mg/m\^2.

BIOLOGICAL

Nivolumab

A defined dose of nivolumab, 3 mg/kg, will be given IV over 30 minutes q 3 weeks

Trial Locations (1)

90403

Sarcoma Oncology Research Center, Santa Monica

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aadi Bioscience, Inc.

INDUSTRY

lead

Sarcoma Oncology Research Center, LLC

OTHER