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KSQ-4279 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by KSQ Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients who are women of childbearing potential with confirmed 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 to 3 months after the last dose of study treatment.
Eastern Cooperative Oncology Group performance status 0 or 1
Must not have
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), PD-1 (anti-programmed death 1) or PD-L1 (anti-programmed death ligand 1) 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, 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 (AIDS) or active infection with hepatitis B virus or hepatitis C virus (HCV), 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years 10 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called RO7623066 to see if it is safe and effective for patients with advanced solid tumors. The study aims to find out if the drug can help manage or reduce these difficult-to-treat cancers.

Who is the study for?
Adults with advanced solid tumors that are not removable or have spread, who've tried standard treatments without success or for whom no standard treatment exists. They must be in good overall health with proper organ function and a life expectancy of at least 12 weeks. Women must use effective contraception, and men agree to barrier contraception during the study.
What is being tested?
The trial is testing KSQ-4279 alone and combined with other therapies on patients with advanced solid tumors. It's a Phase 1 study focusing on safety and how well the drug works, starting with dose escalation to find the right amount before expanding to more patients.
What are the potential side effects?
Specific side effects of KSQ-4279 are not listed but may include typical reactions seen in cancer treatments such as fatigue, nausea, inflammation at injection sites, potential blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during and up to 3 months after the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer can be measured or tracked using specific criteria.
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I have recovered from previous cancer treatments, except for hair loss.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of response (DOR) per RECIST v1.1 Investigator assessment
Effect of food on PK parameters
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and change from baseline in laboratory results
+5 more
Other study objectives
Area under the concentration-time curve( AUC)
Maximum observed concentration (Cmax)
Minimum observed concentration (Cmin)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: RO7623066 Monotherapy (Dose Escalation)Experimental Treatment1 Intervention
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.
Group II: RO7623066 Food Effect CohortExperimental Treatment1 Intervention
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.
Group III: RO7623066 + Olaparib Backfill CohortExperimental Treatment2 Interventions
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.
Group IV: RO7623066 + Olaparib (Dose Escalation and Expansion)Experimental Treatment2 Interventions
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).
Group V: RO7623066 + Carboplatin (Dose Escalation and Expansion)Experimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2190
Carboplatin
2014
Completed Phase 3
~6120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include targeted therapies, immunotherapies, and novel chemotherapeutic agents. Targeted therapies focus on specific molecular pathways critical for tumor growth, such as HER2 or VEGF, thereby inhibiting cancer cell proliferation. Immunotherapies boost the immune system's ability to recognize and destroy cancer cells by blocking inhibitory checkpoints. Novel chemotherapeutic agents often disrupt DNA replication or cell division. These mechanisms are important for solid tumor patients as they enable more personalized and effective treatments, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

KSQ Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
213 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,460 Previous Clinical Trials
1,097,648 Total Patients Enrolled
Brigid GarelikStudy DirectorKSQ Therapeutics, Inc.

Media Library

KSQ-4279 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05240898 — Phase 1
Solid Tumors Research Study Groups: RO7623066 + Olaparib Backfill Cohort, RO7623066 Food Effect Cohort, RO7623066 Monotherapy (Dose Escalation), RO7623066 + Carboplatin (Dose Escalation and Expansion), RO7623066 + Olaparib (Dose Escalation and Expansion)
Solid Tumors Clinical Trial 2023: KSQ-4279 Highlights & Side Effects. Trial Name: NCT05240898 — Phase 1
KSQ-4279 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05240898 — Phase 1
~78 spots leftby Jun 2026