A PHASE 1 STUDY OF RO7623066 ALONE AND IN COMBINATION IN PATIENTS WITH ADVANCED SOLID TUMORS
Details
This is a Phase 1 study to assess the safety and clinical activity of KSQ-4279 alone and in combination in patients with advanced solid tumors. This is a Phase 1 study consisting of 2 parts: Dose Escalation and Expansion to evaluate the safety, tolerability, clinical activity, and pharmacokinetics (PK) Study of KSQ-4279 as a Monotherapy or in Combination in Patients with Advanced Solid Tumors.
Eligibility
You can join if...
Inclusion Criteria:
-Adequate bone marrow and organ function at baseline
-Life expectancy of >12 weeks
-Histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors who meet one of the following criteria (dose escalation only):
a. Relapsed or progressed through standard therapy
b. Have a disease for which no standard effective therapy exists
c.Not a candidate for standard effective therapy
Exclusion Criteria:
-Grade 2 or greater toxicity, except alopecia related to any prior treatment (ie, chemotherapy, targeted therapy, radiation, or surgery)
-Prior anticancer treatment including:
a. Chemotherapy or small molecule-targeted therapy < 2 weeks prior to first dose of study treatment
b. Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest)
c. PD-1 (anti-programmed death 1) or PD-L1 (anti-programmed death ligand 1) therapy < 4 weeks from first dose of study treatment
d. Invasive surgery requiring general anesthesia < 30 days from first dose of study treatment
e. Chemotherapy with nitrosoureas or mitomycin C, < 45 days from first dose of study treatment
f. Radiation therapy (including radiofrequency ablation) < 4 weeks prior to initiation of study treatment