What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as targeted therapies, immunotherapies, and novel chemotherapeutic agents, often have a range of side effects. Targeted therapies can cause side effects like hypertension, hypothyroidism, diarrhea, and fatigue. Immunotherapies, such as durvalumab, may lead to adverse events including pneumonia, pneumonitis, rash, and pruritus. Novel chemotherapeutic agents can result in hematologic toxicities like neutropenia, anemia, and non-hematologic toxicities such as fatigue, nausea, and vomiting. These side effects vary in severity and frequency, and patient management often includes supportive care to mitigate these effects.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors, particularly focusing on targeted therapies and immunotherapies. Pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for various cancers, including advanced melanoma, endometrial cancer, and renal cell carcinoma. Similarly, ipilimumab, an anti-CTLA-4 antibody, is approved for melanoma. Targeted therapies like lenvatinib, a multi-kinase inhibitor, are approved for endometrial cancer in combination with pembrolizumab. Additionally, PARP inhibitors such as olaparib and niraparib are approved for ovarian cancer. These approvals highlight the FDA's focus on innovative treatments that target specific pathways or enhance the immune response against tumors.

What other types of research exist?

Promising alternatives to RO7623066 for solid tumor patients include multitargeted kinase inhibitors like regorafenib, cabozantinib, sorafenib, and lenvatinib, which have shown some activity in advanced solid tumors. Additionally, immunotherapies such as pembrolizumab and nivolumab, either alone or in combination with other agents like ipilimumab, are also promising options. These treatments have demonstrated efficacy in various clinical trials and are being actively investigated for their potential benefits in solid tumor management.

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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

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 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

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

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

0 / 6Eligibility criteria met

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.