A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations

Solid Tumours

Phase 1 Dose Escalation and Phase 1b Sub-study Combination Dose Escalation / Safety Lead-In: Incidence of adverse events characterized by type, seriousness, relationship to study treatment and severity according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 • Incidence of dose-limiting toxicities (DLTs) characterized by type, seriousness, and severity according to NCI CTCAE v5.0 (dose escalation only) • Changes from baseline in safety parameters, Phase 1 Cohort Expansion and Phase 1b Sub-study Combination Cohort or Dose Expansion: Objective response rate (ORR) [Primary endpoint] • Duration of response (DOR) • Progression-free survival (PFS) • Overall survival (OS)

Phase 1 Dose Escalation and Phase 1b Sub-study Combination Dose Escalation / Safety Lead-In: Objective response rate (ORR) • Duration of response (DOR) • Progression-free survival (PFS) • Overall survival (OS), Phase 1 Cohort Expansion and Phase 1b Sub-study Combination Cohort or Dose Expansion: Incidence of adverse events characterized by type, seriousness, relationship to study treatment and severity according to NCI CTCAE v5.0 • Changes from baseline in safety parameters, All Parts Phase 1 and Phase 1b Sub-studies: TER-2013 plasma PK parameters, to include: • Following monotherapy dosing after a single dose and at steady state as data allows: AUClast, AUC0-24, AUCINF, Cmax, Tmax, t½, MRT, CL/F, Vz/F and accumulation ratio at steady state • Following combination treatment: predose and postdose concentrationsudies:. Pharmacodynamic markers of TER-2013 in tumor tissue and/or blood may include but are not limited to pAKT, pPRAS40, and pGSK3β

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