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Advanced Solid TumorsPhase 1NCT05240898

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

A Phase 1 study testing RO7623066, Olaparib and Carboplatin in people with Advanced Solid Tumors, run by Hoffmann-La Roche at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
RO7623066, Olaparib and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
15 sitesUnited States
Study dates
26 Aug 2021to 26 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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
  • Known hypersensitivity to any component of RO7623066 or excipient
  • History of and/or ongoing adrenal disorder (eg, Cushing's disease, Addison's disease, adrenal gland suppression)
  • Suspected pneumonitis or interstitial lung disease (confirmed radiography or by computed tomography [CT]) or a history of pneumonitis or interstitial lung disease in the last 6 months
  • Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for at least 2 years
  • Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or baseline features suggestive of MDS or AML on peripheral blood smear or bone marrow biopsy
  • Treatment with strong or moderate CYP3A4 inhibitors or inducers for a period of 5 half-lives of the inhibitor or inducer prior to the first dose of RO7623066.
  • Blood transfusions within 4 weeks prior to Screening

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Cleveland Clinic,

    Cleveland, Ohio, 44195

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75230

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Maine, 48201-2013

  • South Texas Accelerated Research Therapeutics (START) - Midwest Location

    Grand Rapids, Michigan, 49546

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Yale School of Medicine

    New Haven, Connecticut, 06510-3206

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02906

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 98229

Other trials in United States

About this study

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.

Read the detailed description

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 RO7623066 as a Monotherapy or in Combination in Patients with Advanced Solid Tumors, and a Food Effect Cohort.

Being tested
RO7623066, Olaparib, Carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7623066Drug

    Also called KSQ-4279

    Administered orally in capsule

  • OlaparibDrug

    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.

  • CarboplatinDrug

    Administered intravenously.

Study groups in NCT05240898
Study groupRoleWhat they receive
RO7623066 Monotherapy (Dose Escalation)ExperimentalRO7623066 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.
Receives: Drug: RO7623066
RO7623066 + Olaparib (Dose Escalation and Expansion)ExperimentalRO7623066 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).
Receives: Drug: RO7623066; Drug: Olaparib
RO7623066 + Carboplatin (Dose Escalation and Expansion)ExperimentalRO7623066 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).
Receives: Drug: RO7623066; Drug: Carboplatin
RO7623066 + Olaparib Backfill CohortOtherOnce 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.
Receives: Drug: RO7623066; Drug: Olaparib
RO7623066 Food Effect CohortOtherThe 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.
Receives: Drug: RO7623066

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Approximately 4 years 10 months

Secondary outcomes (8)

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

    Assess safety and tolerability

    Measured: Approximately 4 years 10 months

  2. Pharmacokinetics (PK) parameters of RO7623066

    PK parameters of RO7623066, including maximum plasma concentration (Cmax), time to Cmax (Tmax), total exposure (area under the concentration-time curve [AUC]), clearance (CL), volume of distribution (Vd), and half-life (T1/2)

    Measured: Approximately 4 years 10 months

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

    Anti-tumor activity

    Measured: Approximately 4 years 10 months

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

    Anti-tumor activity

    Measured: Approximately 4 years 10 months

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

    Anti-tumor activity

    Measured: Approximately 4 years 10 months

  6. Time to response (TTR) per RECIST v1.1 Investigator assessment

    Anti-tumor activity

    Measured: Approximately 4 years 10 months

  7. Overall survival (OS), defined as the date of first dose of study drug to the date of death from any cause

    Anti-tumor activity

    Measured: Approximately 4 years 10 months

  8. Effect of food on PK parameters

    PK parameters such as Cmax, Tmax, AUC, and T1/2 for participants who received study treatment who were either in a fed state or in a fasted state.

    Measured: Approximately 4 years 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start26 Aug 2021
  3. Primary completion26 Nov 2025
  4. Study completion26 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240898
Sponsor's protocol ID
WP45169
Other IDs
KSQ-4279-1101
Status last verified
Dec 2025
First submitted
26 Jan 2022
Last updated
18 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mi X, Li Q, Long G, Pan Y, Xie Y, Lu S, Xiao L, Tang J, Zhou L. Deubiquitylating Enzymes in Hepatocellular Carcinoma. Int J Biol Sci. 2025 Jun 20;21(9):4270-4292. doi: 10.7150/ijbs.113193. eCollection 2025.

    PubMed 40607251

  • da Costa AA, Somuncu O, Ravindranathan R, Mukkavalli S, Martignetti DB, Nguyen H, Jiao Y, Lamarre BP, Sadatrezaei G, Moreau L, Liu J, Iyer DR, Lazaro JB, Shapiro GI, Parmar K, D'Andrea AD. Single-Stranded DNA Gap Accumulation Is a Functional Biomarker for USP1 Inhibitor Sensitivity. Cancer Res. 2024 Oct 15;84(20):3435-3446. doi: 10.1158/0008-5472.CAN-23-4007.

    PubMed 38885312

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7623066, Olaparib and Carboplatin in people with Advanced Solid Tumors, run by Hoffmann-La Roche at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Maximum Tolerated Dose (MTD) Measured by the Incidence of Dose Limiting Toxicities (DLTs) (time frame: Approximately 4 years 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240898, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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