A Phase I Study of RO7623066 Alone and in Combination in Patients with Advanced Solid Tumors
Study Description
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
-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
-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
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.