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Studieoverzicht

Study name: Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C -Mutated Solid Tumors. (M24RMC)

Histology NSCLC
Tumor stage Stage IV
Host / recruiting sites Antoni van Leeuwenhoek
Enrollment Recruiting
Therapy line First line (1L) ,  Later line (≥2L)
Design
  • Open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRASG12C -mutated solid tumors.
  • Dose escalation and dose expansion part
Intervention
  • Combination of:
  • RMC-6291, a covalent, biological oral inhibitor of KRASG12C (ON) AND
  • RMC-6236 (RMC-0706236) a biological oral RASMULTI (ON) inhibitor.
Key outcome parameters
  • Incidence and severity of DLT’s, adverse events and changes in laboratory test values.
  • Pharmacokinetics of RMC-6291 and RMC-6236
  • Exploratory cohort:
  • Overall survival
Key inclusion criteria
  • Patients with pathologically documented, KRASG12C -mutated, advanced or metastatic solid tumors who have (1) progressed on or intolerant to standard therapy, or (2) in the opinion of the investigator, not a candidate for or unlikely to derive significant clinical benefit from standard therapy,
  • Part 2. Dose Expansion\
    i. NSCLC, previously treated with a KRASG12C (OFF) inhibitor, including patients with untreated, asymptomatic CNS metastases < 2 cm in size
    ii. NSCLC, naïve to KRASG12C (OFF) inhibitors, including patients with untreated, asymptomatic CNS metastases < 2 cm in size
  • Renal clearance as estimated glomerular filtration rate (eGFR) of 60 mL/min
Key exclusion criteria
  • Untreated brain or leptomeningeal metastases
  • Treated CNS metastases are allowed if: radiotherapy ending at least 2 weeks prior to start. Asymptomatic and on a stable dose of steroid or anticonvulsant therapy. No evidence of radiographic or clinical progression.
  • Impaired cardiovascular function (uncontrolled hypertension, heart failure, acute coronary syndrome within 6 months before start).
  • History of cerebrovascular accident or transient ischemic attack within 6 months prior to start.
  • Has had prior exposure to an inhibitor (eg, small molecule, molecular glue, or degrader) that binds to the guanosine-5'-triphosphate (GTP)-bound state of KRAS, HRAS), or NRAS protein (eg, a RAS(ON) inhibitor)
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