This phase I/II trial will begin to understand how safe and tolerable a new cancer drug (D-1553) is as a monotherapy and combination treatment for people with advanced solid cancers that have a KRasG12C mutationA Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Summary

This trial will be conducted in three parts. The first part (does escalation, Phase Ia) will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, maximum tolerated dose (MTD) and recommended dose for expansion (RDE). The next part (Phase Ib) will determine the MTD of D-1553 in combination with standard treatment for patients with advanced or metastatic NSCLC, CRC and other solid tumours. The final part (Phase II) will evaluate the efficacy of D- 1553 as single agent and as a combination treatment in patients with advanced or metastatic solid tumours that have a KRas G12C mutation. Enrolment into Phase II will be opened after confirmation of the RDE.