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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years 10 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating people with advanced solid tumors.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years 10 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+4 more

Other outcome measures

Area under the concentration-time curve( AUC)

Maximum observed concentration (Cmax)

Minimum observed concentration (Cmin)

+1 more

Trial Design

3Treatment 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 + 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 III: 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

Carboplatin

2014

Completed Phase 3

~6670

Olaparib

2007

Completed Phase 4

~2140

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

KSQ Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

72 Total Patients Enrolled

Hoffmann-La RocheLead Sponsor

2,430 Previous Clinical Trials

1,089,270 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 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall scope of this trial with regards to its geographical reach?

"Patients can be recruited for this trial in a variety of locations, such as Houston Texas, Boston Massachusetts and Hackensack New jersey. There are 5 recruitment sites total."

Answered by AI

Does the Food and Drug Administration recognize KSQ-4279 as a safe medication?

"Our assessment of KSQ-4279's safety is only a 1, as this clinical trial is in its initial stages with limited evidence to back up both its efficacy and security."

Answered by AI

What is the sample size for this clinical exploration?

"This trial necessitates the participation of 140 volunteers who meet all eligibility requirements. The study can be accessed from Houston, Texas and Boston, Massachusetts respectively."

Answered by AI

Are any new participants being accepted for this experiment?

"Confirmed. According to the information published on clinicaltrials.gov, this experiment is actively looking for participants and was posted in August 2021 with an update made in April 2022. To date, 140 individuals are being recruited from 5 different medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05240898.