A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

This is a Phase 1 study to assess the safety and clinical activity of RO7623066 alone and in combination in patients with advanced solid tumors.

Key facts

Study ID

NCT05240898

Run by

Hoffmann-La Roche

People needed

116

Starts

2021-08-26

Expected to finish

2025-11-26

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Life expectancy of ≥ 12 weeks
• Measurable disease or non-measurable disease per RECIST v1.1 in dose escalation and the Food Effect Cohort only; patients in dose expansion and Backfill Cohorts are required to have measurable disease per RECIST v1.1
• Recovered to ≤ Grade 1 or baseline toxicity (except alopecia) from prior therapy (per NCI-CTCAE v5.0)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate bone marrow function defined as:
• absolute neutrophil count of ≥ 1.5 × 109/L
• platelet count of ≥ 100.0 × 109/L
• hemoglobin of ≥ 10.0 g/dL (with or without transfusion)
• Adequate renal function defined as calculated creatinine clearance (Cockcroft- Gault) ≥ 40 mL/min for patients with creatinine levels above institutional normal
• Adequate hepatic function defined as:
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless associated with Gilbert's syndrome
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)
• Female patients who are women of childbearing potential (WOCP) (defined as physiologically and anatomically capable of becoming pregnant), confirmed of a negative pregnancy test and agreement to the use of a highly effective contraceptive method or at least 2 effective methods at the same time during study treatment period and for up to 3 months after the last dose of study treatment. Male patients must be willing to use effective barrier contraception (ie, condoms) during the study treatment period and for up 3 months after the last dose of study treatment
• Capable of understanding and complying with protocol requirements
• Signed and dated institutional review board (IRB)/independent ethics committee (IEC) approved informed consent form (ICF) before any protocol-directed Screening procedures are performed
• Does not require ongoing treatment with strong or moderate CYP3A4 inhibitors or inducers.
• Histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors who meet one of the following criteria (dose escalation only):
• Relapsed or progressed through standard therapy
• Have a disease for which no standard effective therapy exists
• Not a candidate for standard effective therapy Note: In men with prostate cancer, baseline testosterone levels must also be ≤ 50 ng/dL (≤ 2.0 nM) and surgical or ongoing medical castration must be maintained throughout the duration of the study

You may not qualify if…

• Prior anticancer treatment including:
• Chemotherapy or small molecule-targeted therapy < 2 weeks prior to first dose of study treatment
• Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest)
• Programmed cell death protein-1 or programmed cell death ligand 1 inhibitor therapy < 4 weeks from first dose of study treatment
• Invasive surgery requiring general anesthesia < 30 days from first dose of study treatment
• Chemotherapy with nitrosoureas or mitomycin C < 45 days from first dose of study treatment
• Radiation therapy (including radiofrequency ablation) < 4 weeks prior to initiation of study treatment Note: Prior stereotactic body radiation therapy or local palliative radiation is allowed < 2 weeks prior to first dose of study treatment
• Ongoing Grade 2 or greater toxicity, except alopecia, related to any prior treatment (ie, chemotherapy, targeted therapy, radiation, or surgery)
• Prolongation of QT/QTc interval (QTc interval > 480 msec) using the Frederica method of QTc analysis
• Women who are pregnant or nursing
• Seropositive for human immunodeficiency virus (HIV) 1 or 2 or acquired immunodeficiency syndrome or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) (Note: Patients with positive HCV antibody may be eligible if HCV ribonucleic acid [RNA] is undetectable on a quantitative HCV RNA assay, the Medical Monitor is available for advice)
• Primary malignant brain tumor
• Symptomatic and/or untreated brain metastases, active leptomeningeal disease, or central nervous system malignant disease requiring steroids or other therapeutic intervention Note: Patients with definitively treated brain metastases will be considered for enrollment after seeking advice from the Medical Monitor and must be clinically stable for ≥ 2 weeks prior to the start of treatment
• Previous solid organ or hematopoietic cell transplant
• Need for treatment with steroids at stable doses (> 10 mg prednisone or equivalent per day). Note: Oral steroids up to 10 mg/day, topical, ophthalmic, or inhaled steroid medications are allowed
• Uncontrolled hypertension > 150/100 mm Hg despite aggressive therapy
• Concurrent participation in any other investigational therapeutic study
• History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to first dose of study treatment
• Unable to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube)administration is not allowed
• GI disease that would impair ability to swallow, retain, or absorb drug is not allowed
• Uncontrolled concurrent disease or illness including but not limited to:
• Symptomatic congestive heart failure according to New York Heart Association (NYHA) classification, Class III or IV (per NYHA Classification) unstable angina pectoris, or clinically significant cardia arrhythmia
• Diabetes mellitus (ie, fasting blood glucose > 220 despite acceptable chronic diabetes therapy)
• Psychiatric illness that would limit compliance with study requirements, as determined by the Investigator
• Other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or that may interfere with the interpretation of the study results, and in the judgment of the Investigator, would make the patient inappropriate for the study

Where it is running

• University of California Irvine Medical Center — Orange, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Maine, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• South Texas Accelerated Research Therapeutics (START) - Midwest Location — Grand Rapids, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Cleveland Clinic, — Cleveland, Ohio, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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