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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 : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
KSQ Therapeutics, Inc.

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 Drug: KSQ-4279 will be combined in separate cohorts, including combination with an oral PARPi (poly adenosine diphosphate-ribose polymerase inhibitor) 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 : December 19, 2023
Estimated Study Completion Date : October 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

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). These cohorts will be enrolled in parallel.
Drug: KSQ-4279
Administered orally in capsule
Other Name: USP1 (Ubiquitin Specific Protease 1) inhibitor 4279

Drug: KSQ-4279 will be combined in separate cohorts, including combination with an oral PARPi (poly adenosine diphosphate-ribose polymerase inhibitor)
KSQ-4279 will be combined in separate cohorts, including combination with an oral PARPi (poly adenosine diphosphate-ribose polymerase inhibitor)




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: Patricia Harris 617-674-9187 pharris@ksqtx.com
Contact: Brigid Garelik 617-674-9187 bgarelik@ksqtx.com

Locations
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United States, Massachusetts
Boston, Massachusetts Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Grand Rapids, Michigan Recruiting
Grand Rapids, Michigan, United States, 49546-7062
United States, New Jersey
Hackensack, NJ Recruiting
Hackensack, New Jersey, United States, 07601
United States, Texas
Houston, TX Recruiting
Houston, Texas, United States, 77030-4000
San Antonio,TX Recruiting
San Antonio, Texas, United States, 78229-3307
Sponsors and Collaborators
KSQ Therapeutics, Inc.
Investigators
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Study Director: Brigid Garelik KSQ Therapeutics, Inc.
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Responsible Party: KSQ Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05240898    
Other Study ID Numbers: KSQ-4279-1101
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
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
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action