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Monoclonal Antibodies

Sapanisertib + Bevacizumab for Glioblastoma

Phase 1

Waitlist Available

Led By Lakshmi Nayak

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histologically/cytologically confirmed diagnosis of recurrent glioblastoma or an advanced solid tumor in which bevacizumab has shown benefit

Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma

Must not have

Uncontrolled high blood pressure, pulmonary hypertension, uncontrolled asthma, poorly controlled diabetes mellitus

History or presence of clinically significant cardiac, pulmonary, gastrointestinal, hematological, endocrine, renal, hepatic, or infectious conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of the TORC1/2 inhibitor MLN0128 when given in combination with bevacizumab in treating patients with glioblastoma or other solid tumors.

Who is the study for?

This trial is for adults with recurrent glioblastoma or advanced solid tumors that haven't responded to standard treatments. Participants must be able to swallow capsules, have no other concurrent cancers (except certain skin cancers), and use contraception if of child-bearing potential. They should not be on corticosteroids, pregnant, nursing, or have significant allergies to the drugs being tested.

What is being tested?

The trial is testing a combination of TORC1/2 inhibitor MLN0128 and monoclonal antibody Bevacizumab in patients with specific types of brain and solid tumors. It aims to find the safest dose while assessing how these drugs might block tumor growth by inhibiting enzymes needed for cell growth and blood vessel formation.

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as increased risk of infection, high blood pressure issues, gastrointestinal disturbances which could affect drug absorption, allergic reactions similar in nature to those from compounds like MLN0128 or Bevacizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of recurrent glioblastoma or an advanced cancer treatable with bevacizumab.

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I have no other cancers except possibly treated skin cancer.

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I can take care of myself but might not be able to do heavy physical work.

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I am not currently taking corticosteroids.

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I can swallow whole capsules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled high blood pressure, asthma, or diabetes.

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I do not have any major heart, lung, stomach, blood, hormone, kidney, liver, or infectious diseases.

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My heart health meets the study's requirements.

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I am HIV-positive and on combination antiretroviral therapy.

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I am not taking any specific medications or herbal supplements.

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I have allergies to drugs similar to MLN0128 or bevacizumab.

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I have brain metastases that are causing symptoms or getting bigger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 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 (MTD) and Recommended Phase 2 Dose (R2PD) of Daily Oral MLN0128 When Administered With Bevacizumab

Most Common Related Toxicities That Led to Dose Hold/Reductions

Secondary study objectives

Number of Participants Who Had an MLN0128 Dose-Reduction On Study

Number of Participants With Toxicities Leading to Missed Doses or Delays

Number of Patients That Discontinue Study Drugs Due to Treatment Related Toxicity

+3 more

Other study objectives

Cerebrospinal Fluid (CSF) Penetration of TORC1/2 Inhibitor MLN0128, Evaluated Using Plasma and CSF Pharmacokinetic (PK) Parameters of MLN0128

Markers Associated With Dysregulated Cell Signaling

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TORC1/2 inhibitor INK128, bevacizumab)Experimental Treatment4 Interventions

Patients receive TORC1/2 inhibitor INK128 PO QD on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Sapanisertib

2016

Completed Phase 2

~840