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A Phase 1 Study of KSQ-4279 Alone and in Combination in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05240898
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: KSQ-4279 Monotherapy (Dose Escalation and Expansion) Drug: KSQ-4279 Combination Therapy (Dose Escalation and Expansion) Phase 1

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 KSQ-4279 as a Monotherapy or in Combination in Patients with Advanced Solid Tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of KSQ-4279 Alone and in Combination in Patients With Advanced Solid Tumors
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : June 24, 2024
Estimated Study Completion Date : February 28, 2025

Arm Intervention/treatment
Experimental: KSQ-4279 Monotherapy and KSQ-4279 + Combination (Dose Escalation and Expansion)
KSQ-4279 will be administered orally once daily (QD) continuously as monotherapy. Once the maximum tolerated dose (MTD) for KSQ-4279 monotherapy has been reached, KSQ-4279 will be combined in separate cohorts, including combination with an oral PARPi (poly adenosine diphosphate-ribose polymerase inhibitor) and combination with a platinum-based chemotherapy. These cohorts will be enrolled in parallel.
Drug: KSQ-4279 Monotherapy (Dose Escalation and Expansion)
Administered orally in capsule
Other Name: USP1 (Ubiquitin Specific Protease 1) inhibitor 4279

Drug: KSQ-4279 Combination Therapy (Dose Escalation and Expansion)
KSQ-4279 will be combined in separate cohorts, including combination with an oral PARPi (poly adenosine diphosphate-ribose polymerase inhibitor) and combination with a platinum-based chemotherapy.




Primary Outcome Measures :
  1. The maximum tolerated dose (MTD) [ Time Frame: Approximately18 months ]

Secondary Outcome Measures :
  1. Incidence and severity of TEAEs (Treatment Emergent Adverse Events) [ Time Frame: Approximately 18 months ]
    Assess safety and tolerability

  2. Overall Response Rate (ORR) per RECIST V1.1 [ Time Frame: Approximately18 months ]
    anti-tumor activity


Other Outcome Measures:
  1. Maximum observed concentration (Cmax) [ Time Frame: Predose and up to 12 hours postdose. ]
    Measure the maximum observed concentration for KSQ-4279 alone and in combination

  2. Time to maximum observed concentration (Tmax) [ Time Frame: Predose and up to 12 hours postdose. ]
    Measure time to maximum observed concentration for KSQ-4279 alone and in combination

  3. Minimum observed concentration (Cmin) [ Time Frame: Predose and up to 12 hours postdose ]
    Measure time to Minimum observed concentration for KSQ-4279 alone and in combination

  4. Area under the concentration-time curve( AUC) [ Time Frame: Predose and up to 12 hours postdose. ]
    Measure area under the concentration-time curve for KSQ-4279 alone and in combination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Life expectancy of ≥ 12 weeks
  3. Measurable disease or non-measurable per RECIST v1.1 in dose escalation only; patients in dose expansion are required to have measurable disease per RECIST v1.1
  4. Recovered to ≤ Grade 1 or baseline toxicity (except alopecia) from prior therapy (per NCI-CTCAE v5.0)
  5. Eastern Cooperative Oncology Group performance status 0 or 1
  6. Adequate bone marrow and organ function at baseline
  7. Female patients who are women of childbearing potential with 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 during the study treatment period and for up 3 months after the last dose of study treatment.
  8. Histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors who meet one of the following criteria (dose escalation only):

    1. Relapsed or progressed through standard therapy
    2. Have a disease for which no standard effective therapy exists
    3. Not a candidate for standard effective therapy

Exclusion Criteria:

  1. Prior anticancer treatment including:

    1. Chemotherapy or small molecule-targeted therapy < 2 weeks prior to first dose of study treatment
    2. Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest)
    3. PD-1 (anti-programmed death 1) or PD-L1 (anti-programmed death ligand 1) therapy < 4 weeks from first dose of study treatment
    4. Invasive surgery requiring general anesthesia < 30 days from first dose of study treatment
    5. Chemotherapy with nitrosoureas or mitomycin C, < 45 days from first dose of study treatment
    6. Radiation therapy (including radiofrequency ablation) < 4 weeks prior to initiation of study treatment
  2. Grade 2 or greater toxicity, except alopecia related to any prior treatment (ie, chemotherapy, targeted therapy, radiation, or surgery)
  3. Prolongation of QT/QTc interval (QTc interval > 480 msec) using the Frederica method of QTc analysis
  4. Women who are pregnant or nursing
  5. Seropositive for human immunodeficiency virus (HIV) 1 or 2 or acquired immunodeficiency syndrome (AIDS) or active infection with hepatitis B virus or hepatitis C virus (HCV)
  6. 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 judgement of the Investigator, would make the patient inappropriate for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05240898


Contacts
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Contact: Reference Study ID Number: WP45169 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, California
University of California - Irvine Medical Center Recruiting
Orange, California, United States, 92697
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546-7062
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma University - Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
Lifespan Cancer Institute Recruiting
Providence, Rhode Island, United States, 02903
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4000
START San Antonio Recruiting
San Antonio, Texas, United States, 78229-3307
United States, Virginia
UVA Health System Recruiting
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05240898    
Other Study ID Numbers: WP45169
KSQ-4279-1101 ( Other Identifier: KSQ Therapeutics, Inc. )
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms