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Active, Not Recruiting

NCT Number: NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nepean Cancer Centre, Kingswood, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women greater than or equal to 18 years old.
  • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion criteria

  • Primary brain tumor.
  • Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Treatment and study plan

Sotorasib

Drug

Sotorasib administered orally as a tablet.

Trametinib

Drug

Trametinib administered orally as a tablet.

RMC-4630

Drug

RMC-4630 administered orally as a capsule.

afatinib

Drug

afatinib administered orally as a tablet.

Pembrolizumab

Drug

pembrolizumab administered as an intravenous (IV) infusion.

Panitumumab

Drug

Panitumumab administered as an IV infusion.

Carboplatin, pemetrexed, docetaxel, paclitaxel

Drug

Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

Atezolizumab

Drug

Atezolizumab administered as an IV injection.

Palbociclib

Drug

Palbociclib administered orally as a tablet.

MVASI® (bevacizumab-awwb)

Drug

MVASI® (bevacizumab-awwb) administered as an IV infusion.

TNO155

Drug

TNO155 administered orally as a capsule.

IV Chemotherapy (Regimen 1)

Drug

Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

IV Chemotherapy (Regimen 2)

Drug

IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

BI 1701963

Drug

BI 1701963 administered orally

AMG 404

Drug

AMG 404 administered as an IV infusion.

Everolimus

Drug

Everolimus administered orally.

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: 12 Months

  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: 12 Months

  3. Number of Participants with Treatment-related Adverse Events

    Time frame: 12 Months

  4. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: 12 Months

  5. Number of Participants with Clinically Significant Changes in ECG Measurements

    Time frame: 12 Months

  6. Number of Participants with Clinically Significant Changes in Laboratory Test Values

    Time frame: 12 Months

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: 12 Months

  2. Time to Maximum Plasma Concentration (Tmax)

    Time frame: 12 Months

  3. Area Under the Plasma Concentration-time Curve (AUC)

    Time frame: 12 Months

  4. Objective Response Rate

    Time frame: 12 Months

  5. Disease Control Rate

    Time frame: 12 Months

  6. Duration of Response

    Time frame: 12 Months

  7. Progression-free Survival

    Time frame: 12 Months

  8. Duration of Stable Disease

    Time frame: 12 Months

  9. Time to Response

    Time frame: 12 Months

  10. Overall Survival

    Time frame: 12 Months

  11. Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels

    Time frame: 12 Months

  12. Sotorasib Monotherapy Only: Intracranial Objective Response Rate

    Time frame: 12 Months

    Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).

  13. Sotorasib Monotherapy Only: Intracranial Disease Control Rate

    Time frame: 12 Months

    Intracranial disease control rate assessed per RANO-BM.

  14. Sotorasib Monotherapy Only: Intracranial Duration of Response

    Time frame: 12 Months

    Intracranial duration of response assessed per RANO-BM.

  15. Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy

    Time frame: 12 Months

  16. Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)

    Time frame: 12 Months

    Intracranial PFS assessed per RANO-BM.

  17. Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)

    Time frame: 12 Months

    Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  18. Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)

    Time frame: 12 Months

    Overall PFS assessed per RECIST 1.1 and RANO-BM.

  19. Sotorasib + TNO155 Only: Best Overall Response

    Time frame: 12 Months

  20. Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: 12 Months

  21. Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: 12 Months

  22. Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events

    Time frame: 12 Months

  23. Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: 12 Months

  24. Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements

    Time frame: 12 Months

  25. Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values

    Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Dec 4, 2019
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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