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Small Molecule Drug

Adagrasib + TNO155 for Cancer

Phase 1 & 2

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

Unresectable or metastatic disease

Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation (phase 2 must be either Non-Small Cell Lung Cancer or Colorectal Cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 months

Awards & highlights

Study Summary

This trial will study a new combination cancer drug in patients with advanced solid tumors and a specific KRAS mutation.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. It's especially focused on those with lung or colorectal cancer who can't be cured by surgery or other treatments, and whose organs are working well. People with heart problems, certain gut diseases, or another active cancer cannot join.Check my eligibility

What is being tested?

The study tests the combination of two drugs: Adagrasib (MRTX849) and TNO155 in patients. Researchers want to see how safe they are together, what levels stay in the blood, their effects on tumor biology, and if they help control cancer growth.See study design

What are the potential side effects?

Possible side effects include reactions at the drug injection site, changes in liver function tests indicating liver stress, fatigue from treatment-related anemia or low energy levels, nausea due to gastrointestinal disturbances caused by medication.

Eligibility Criteria

Inclusion Criteria

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

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My cancer cannot be removed by surgery or has spread to other parts of my body.

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My cancer has a KRAS G12C mutation.

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There are no treatments that can cure my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Characterize the safety of MRTX849 and TNO155 in patients having advanced solid tumor malignancies with KRAS G12C mutation.

Evaluate the pharmacokinetics of MRTX849 and TNO155

Secondary outcome measures

Establish maximum tolerated dose

Evaluate clinical activity of MRTX849

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment2 Interventions

Separate cohorts of patients stratified by histological diagnosis for evaluation of clinical activity to evaluate clinical activity of MRTX849 and TNO155 in combination

Group II: Phase 1b ExpansionExperimental Treatment2 Interventions

Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with TNO155 to recommend Phase 2 regimens

Group III: Phase 1 Dose ExplorationExperimental Treatment2 Interventions

Dose escalation of TNO155 to determine maximum tolerated dose of TNO155 in combination with MRTX849

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRTX849

2021

Completed Phase 1

~10

0 / 3Eligibility criteria met