Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

NCT06128551
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
clinicaltrials.gov
Participants
534
clinicaltrials.gov
Lead sponsor
Revolution Medicines, Inc.
clinicaltrials.gov
Start date
2023-11-14
clinicaltrials.gov
Number of sites
56
clinicaltrials.gov

Summary
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
clinicaltrials.gov
Short title
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
clinicaltrials.gov
Official title
Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors
clinicaltrials.gov

Control arm
Open label
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Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2029-06-01
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First posted
2023-11-13
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Registry last updated
2026-09-22
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Primary completion date
2028-12-01
clinicaltrials.gov
Start date
2023-11-14
clinicaltrials.gov

Participants
534
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
534
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Protocol amendments
3
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Number of sites
56
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Revolution Medicines, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06128551
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06128551
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Masking description
None (Open Label)
Sources for study design
clinicaltrials.gov

  1. Number of patients with adverse events (AEs) in Phase 1b

    Timeframe: Up to approximately 3 years

    Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

  2. Changes in vital signs in Phase 1b

    Timeframe: Up to approximately 3 years

    Number of patients with clinically significant changes in vital signs

  3. Changes in clinical laboratory test values in Phase 1b

    Timeframe: Up to approximately 3 years

    Number of patients with clinically significant changes in clinical laboratory test values

  4. Dose Limiting Toxicities in Phase 1b

    Timeframe: 21 days

    Number of participants with dose limiting toxicities

  5. Changes in ECGs in Phase 1b

    Timeframe: Up to approximately 3 years

    Number of patients with clinically significant changes in ECGs

  6. Overall Response Rate (ORR) in Phase 2

    Timeframe: Up to approximately 3 years

    Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)

  1. Maximum Observed Blood Concentration of Elironrasib and Daraxonrasib

    Timeframe: up to 21 weeks

    Cmax

  2. Time to Reach Maximum Blood Concentration of Elironrasib and Daraxonrasib

    Timeframe: up to 21 weeks

    Tmax

  3. Area Under Blood Concentration Time Curve of Elironrasib and Daraxonrasib

    Timeframe: up to 21 weeks

    AUC

  4. Elimination Half-Life of Elironrasib and Daraxonrasib

    Timeframe: up to 21 weeks

    t1/2

  5. Ratio of accumulation of Elironrasib and Daraxonrasib from a single dose to steady state with repeated dosing

    Timeframe: up to 21 weeks

    accumulation ratio

  6. Overall Response Rate (ORR) in Phase 1b

    Timeframe: Up to approximately 3 years

    Overall response rate per RECIST v1.1

  7. Duration of Response (DOR)

    Timeframe: Up to approximately 3 years

    Duration of response per RECIST v1.1

  8. Disease Control Rate in Phase 1b

    Timeframe: Up to approximately 3 years

    Disease Control rate per RECIST v1.1

  9. Time to Response (TTR) in Phase 1b

    Timeframe: Up to approximately 3 years

    Time to response per RECIST v1.1

  10. Progression-Free Survival (PFS)

    Timeframe: Up to approximately 3 years

    Progression-free survival per RECIST v1.1

  11. Number of patients with AEs in Phase 2

    Timeframe: Up to approximately 3 years

    Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5

  12. Changes in vital signs in Phase 2

    Timeframe: Up to approximately 3 years

    Number of patients with clinically significant changes in vital signs

  13. Changes in clinical laboratory values in Phase 2

    Timeframe: Up to approximately 3 years

    Number of patients with clinically significant changes in clinical laboratory test values

  14. Overall Survival (OS) in Phase 2

    Timeframe: Up to approximately 3 years

    OS is defined as time from enrollment until death from any cause

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 18 years of age

  • Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

    1. Phase 1b Dose Escalation: solid tumors, previously treated
    2. Phase 1b Dose Expansion and Phase 2:

    i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.

  • ECOG performance status 0 or 1

  • Adequate organ function

  • Primary central nervous system (CNS) tumors
  • Active brain metastases
  • Known impairment of GI function that would alter the absorption
  • Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment
Sources for eligibility
clinicaltrials.gov

  • City of HopeDuarte, United StatesWithdrawn
  • UC IRVINE HealthOrange, United StatesRecruiting
  • UC Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting
  • Stanford Cancer InstituteStanford, United StatesRecruiting
  • University of Colorado Cancer CenterAurora, United StatesRecruiting
  • Florida Cancer SpecialistsSarasota, United StatesRecruiting
  • Moffitt Cancer Center and Research InstituteTampa, United StatesRecruiting
  • Community Health NetworkIndianapolis, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • Henry Ford CancerDetroit, United StatesWithdrawn
  • START MidwestGrand Rapids, United StatesRecruiting
  • Columbia UniversityNew York, United StatesRecruiting
  • NYU Langone HealthNew York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • University of OklahomaOklahoma City, United StatesRecruiting
  • Allegheny Health NetworkPittsburgh, United StatesRecruiting
  • Sarah Cannon Research InstitueNashville, United StatesRecruiting
  • Mary Crowley Cancer ResearchDallas, United StatesCompleted
  • MD AndersonHouston, United StatesRecruiting
  • NEXT DallasIrving, United StatesRecruiting
  • NEXT Oncology San AntonioSan Antonio, United StatesRecruiting
  • START TexasSan Antonio, United StatesRecruiting
  • NEXT Oncology VirginiaFairfax, United StatesRecruiting
  • West Cancer InstituteAngers, FranceRecruiting
  • Institut BergonieBordeaux, FranceRecruiting

And 31 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (21)