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Small Molecule Inhibitor

Adagrasib + Nab-Sirolimus for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new combo of drugs to treat advanced solid tumors/lung cancer with a genetic mutation.

Who is the study for?

This trial is for adults with advanced solid tumors or non-small cell lung cancer (NSCLC) that have a specific genetic change called KRAS G12C mutation. They should not be candidates for surgery to remove the tumor and must not have any other curative treatment options available. Their body's major functions need to be stable, and they must have measurable signs of cancer according to certain medical criteria.

What is being tested?

The study is testing a combination of two drugs: Adagrasib and nab-Sirolimus, in patients with advanced cancers that carry the KRAS G12C mutation. It aims to find out the safest dose levels, how the body processes these drugs, and their effectiveness against these types of cancers.

What are the potential side effects?

Potential side effects from Adagrasib may include fatigue, nausea, diarrhea, liver enzyme changes, while nab-Sirolimus might cause mouth sores, rash or skin issues, increased blood sugar levels among others. The combination's side effects will also be studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

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

Phase 1: Maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D)

Phase 1: Safety and tolerability in the study population.

Phase 2: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Phase 2)

Secondary study objectives

Area under the plasma concentration versus time curve (AUC)

Maximum observed plasma concentration

Phase 1 and 2: Evaluate efficacy endpoints characterized by overall survival, progression-free survival, and duration of response in the study population.

+4 more

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: Dose Escalation and Clinical EfficacyExperimental Treatment2 Interventions

Dose escalation of adagrasib and nab-Sirolimus to determine maximum tolerated dose in combination and evaluate the clinical efficacy of adagrasib in combination with nab-sirolimus in patients with solid tumors (Phase 1) and NSCLC (Phase 2) harboring a KRAS G12C mutation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adagrasib

2023

Completed Phase 1

~20

nab-Sirolimus

2015

Completed Phase 2

~40