FLAGSHP-1: This phase I trial is evaluating how safe and effective a targeted cancer drug (ERAS-601) is alone, or when combined with another targeted therapy (Cetuximab) in people with advanced or metastatic solid cancersAn Open-Label, Multi-Center Phase 1/1b Dose Escalation and Expansion Study of ERAS-601 SHP2 Inhibitor as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors

Summary

This is a non-randomised, open-label trial with dose escalation of ERAS-601 monotherapy, followed by dose escalation of ERAS-601 in combination with other cancer therapies. Once the monotherapy MTD and/or RD has been determined, then dose expansion of ERAS-601 monotherapy may commence with enrolment of study participants with advanced or metastatic solid tumours harbouring specific molecular alterations. Once the combination therapy MTD and/or RD has been determined, then dose expansion of that combination may commence with enrolment of study participants with advanced or metastatic solid tumours harbouring specific molecular alterations. ERAS-601 will be administered orally, and in the dose escalation phase will be administered in sequential ascending doses. In the dose expansion phase, ERAS-601 will be administered at the recommended dose as determined from the dose escalation phase. For those enrolled in the ERAS-601 + cetuximab arm, cetuximab will be administered via intravenous infusion.

Treatment Type

Radiotherapy