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mTOR inhibitor

Arm 1 for Squamous Cell Carcinoma

Phase 1 & 2
Waitlist Available
Led By Erlinda M Gordon, MD
Research Sponsored by Sarcoma Oncology Research Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

Summary

This trial is testing the safety and potential effectiveness of a new cancer treatment involving two drugs, nivolumab and ABI-009. The study will enroll patients with various types of cancer.

Eligible Conditions
  • Squamous Cell Carcinoma
  • Liver Cancer
  • PEComas
  • mTOR Activation
  • Chordoma
  • Ewing Sarcoma
  • Colorectal Cancer
  • Epithelioid Sarcoma
  • Non-Small Cell Lung Cancer
  • Hodgkin's Lymphoma
  • Desmoid Tumors
  • Bladder Cancer
  • Melanoma
  • Kidney Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose
Secondary study objectives
Disease control rate
Overall survival
Progression free survival
Other study objectives
Disease control rate and PD-L1 expression in tumors

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
This is an open label, dose-seeking phase 1b study using a defined dose of nivolumab and escalating doses of Nab-Rapamycin (ABI-009) given intravenously. I. Dose Escalation Phase 1 Part of Study: The study will employ the standard "cohort of three" design. No intra-patient dose escalation will take place. II. Expansion Phase 1b Part of Study: Following dose escalation, an additional 22-28 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 three-week cycles or until significant disease progression or unacceptable toxicity occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-Rapamycin
2017
Completed Phase 2
~40
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Sarcoma Oncology Research Center, LLCLead Sponsor
8 Previous Clinical Trials
532 Total Patients Enrolled
Aadi Bioscience, Inc.Industry Sponsor
17 Previous Clinical Trials
544 Total Patients Enrolled
Erlinda M Gordon, MDPrincipal InvestigatorSarcoma Oncology Research Center
3 Previous Clinical Trials
85 Total Patients Enrolled
~4 spots leftby Sep 2025
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