A Phase 1 Study of KSQ-4279 Alone and in Combination in Patients With Advanced Solid Tumors
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
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)
|
Outcome Measures
Primary Outcome Measures
- The maximum tolerated dose (MTD) [Approximately18 months]
Secondary Outcome Measures
- Incidence and severity of TEAEs (Treatment Emergent Adverse Events) [Approximately 18 months]
Assess safety and tolerability
- Overall Response Rate (ORR) per RECIST V1.1 [Approximately18 months]
anti-tumor activity
Other Outcome Measures
- Maximum observed concentration (Cmax) [Predose and up to 12 hours postdose.]
Measure the maximum observed concentration for KSQ-4279 alone and in combination
- Time to maximum observed concentration (Tmax) [Predose and up to 12 hours postdose.]
Measure time to maximum observed concentration for KSQ-4279 alone and in combination
- Minimum observed concentration (Cmin) [Predose and up to 12 hours postdose]
Measure time to Minimum observed concentration for KSQ-4279 alone and in combination
- Area under the concentration-time curve( AUC) [Predose and up to 12 hours postdose.]
Measure area under the concentration-time curve for KSQ-4279 alone and in combination
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older
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Life expectancy of ≥ 12 weeks
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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
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Recovered to ≤ Grade 1 or baseline toxicity (except alopecia) from prior therapy (per NCI-CTCAE v5.0)
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Eastern Cooperative Oncology Group performance status 0 or 1
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Adequate bone marrow and organ function at baseline
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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.
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Histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors who meet one of the following criteria (dose escalation only):
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Relapsed or progressed through standard therapy
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Have a disease for which no standard effective therapy exists
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Not a candidate for standard effective therapy
Exclusion Criteria:
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Prior anticancer treatment including:
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Chemotherapy or small molecule-targeted therapy < 2 weeks prior to first dose of study treatment
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Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest)
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PD-1 (anti-programmed death 1) or PD-L1 (anti-programmed death ligand 1) therapy < 4 weeks from first dose of study treatment
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Invasive surgery requiring general anesthesia < 30 days from first dose of study treatment
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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
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Grade 2 or greater toxicity, except alopecia related to any prior treatment (ie, chemotherapy, targeted therapy, radiation, or surgery)
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Prolongation of QT/QTc interval (QTc interval > 480 msec) using the Frederica method of QTc analysis
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Women who are pregnant or nursing
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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)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston, Massachusetts | Boston | Massachusetts | United States | 02115 |
| 2 | Grand Rapids, Michigan | Grand Rapids | Michigan | United States | 49546-7062 |
| 3 | Hackensack, NJ | Hackensack | New Jersey | United States | 07601 |
| 4 | Houston, TX | Houston | Texas | United States | 77030-4000 |
| 5 | San Antonio,TX | San Antonio | Texas | United States | 78229-3307 |
Sponsors and Collaborators
- KSQ Therapeutics, Inc.
Investigators
- Study Director: Brigid Garelik, KSQ Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KSQ-4279-1101