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

NCT05240898 | Completed Phase 1 FDA Drug

• 2 other identifiers: WP45169KSQ-4279-1101
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• The Maximum Tolerated Dose (MTD) Measured by the Incidence of Dose Limiting Toxicities (DLTs)

  Approximately 4 years 10 months

Secondary Outcomes (8)

• Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and change from baseline in laboratory results

  Approximately 4 years 10 months

• Pharmacokinetics (PK) parameters of RO7623066

  Approximately 4 years 10 months

• Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Investigator assessment

  Approximately 4 years 10 months

• Progression-free survival (PFS) per RECIST v1.1 Investigator assessment

  Approximately 4 years 10 months

• Duration of response (DOR) per RECIST v1.1 Investigator assessment

  Approximately 4 years 10 months

Study Arms (5)

RO7623066 Monotherapy (Dose Escalation)

EXPERIMENTAL

RO7623066 will be administered orally once daily (QD) continuously as monotherapy. Once the maximum tolerated dose (MTD) for RO7623066 monotherapy has been reached this concludes the Dose Escalation phase.

Drug: RO7623066

RO7623066 + Olaparib (Dose Escalation and Expansion)

EXPERIMENTAL

RO7623066 will be tested in combination with olaparib. Escalating dose levels will be tested until the maximum tolerated dose (MTD), or lower, of RO7623066 is reached or MTD, or lower, of the combination is reached (whichever occurs first). Combination arms can enroll concurrently. Olaparib will be dosed per standard of care (SoC).

Drug: RO7623066; Drug: Olaparib

RO7623066 + Carboplatin (Dose Escalation and Expansion)

EXPERIMENTAL

RO7623066 will be tested in combination with carboplatin. Escalating dose levels will be tested until the maximum tolerated dose (MTD), or lower, of RO7623066 is reached or MTD, or lower, of the combination is reached (whichever occurs first). Combination arms can enroll concurrently. Carboplatin will be dosed per standard of care (SoC).

Drug: RO7623066; Drug: Carboplatin

RO7623066 + Olaparib Backfill Cohort

OTHER

Once safety data has been obtained in the RO7623066 + Olaparib arm during the dose escalation phase, Backfill cohorts will be used to determine the Recommended Dose for Expansion of RO7623066 + Olaparib.

Drug: RO7623066; Drug: Olaparib

RO7623066 Food Effect Cohort

OTHER

The effect of food intake on the PK of RO7623066 will be explored at a dose close to the Maximum Tolerated Dose (MTD) and/or at Recommended Phase II Dose (RP2D) or at a relevant dose level for a minimum of 12 participants that have at least one tumor mutation of interest.

Drug: RO7623066

Interventions

RO7623066 DRUG

Administered orally in capsule

Also known as: KSQ-4279

RO7623066 + Carboplatin (Dose Escalation and Expansion); RO7623066 + Olaparib (Dose Escalation and Expansion); RO7623066 + Olaparib Backfill Cohort; RO7623066 Food Effect Cohort; RO7623066 Monotherapy (Dose Escalation)

Olaparib DRUG

Administered orally. Dose levels and schedules will be selected based on integration of preclinical data as well as clinical PK, safety, efficacy, and PD/biomarker data (as appropriate) from the dose escalation cohorts.

RO7623066 + Olaparib (Dose Escalation and Expansion); RO7623066 + Olaparib Backfill Cohort

Carboplatin DRUG

Administered intravenously.

RO7623066 + Carboplatin (Dose Escalation and Expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510-3206, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Maine, 48201-2013, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

South Texas Accelerated Research Therapeutics (START) - Midwest Location

Grand Rapids, Michigan, 49546, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cleveland Clinic,

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75230, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 98229, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Interventions

olaparib; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 15, 2022
• Study Start: August 26, 2021
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)