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A Phase I Study of RO7623066 Alone and in Combination in Patients with Advanced Solid Tumors

UCI Specialty Area: Cancer
Principal Investigator: Krishnansu Tewari
Official Title: A Phase I Study of RO7623066 Alone and in Combination in Patients with Advanced Solid Tumors
A Study On:
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Kidney
Larynx
Lip Oral Cavity and Pharynx
Liver
Lung
Melanoma skin
Multiple Myeloma
Other Digestive Organ
Other Endocrine System
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder

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

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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