What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapeutic agents and targeted therapies, often have a range of side effects. Chemotherapy can cause nausea, diarrhea, neutropenia, thrombocytopenia, fatigue, neuropathy, and febrile neutropenia. Targeted therapies, like those involving olaparib, may lead to anemia, fatigue, nausea, and increased risk of infections. These side effects vary in severity and frequency depending on the specific drugs and combinations used.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that focus on targeted therapies and combination regimens. For instance, olaparib, a PARP inhibitor, has been approved for use in combination with other agents for certain types of advanced solid tumors, including ovarian and breast cancers. Other targeted therapies, such as pembrolizumab and nivolumab, which are immune checkpoint inhibitors, have also received FDA approval for various solid tumors, including melanoma and non-small cell lung cancer. These treatments, like XL309, aim to improve safety, tolerability, and antitumor activity while providing detailed pharmacokinetic and pharmacodynamic profiles.

What other types of research exist?

Promising alternatives to XL309 for solid tumors include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in various solid tumors. 2) Nivolumab combined with Ipilimumab, another immune checkpoint inhibitor combination, has demonstrated significant antitumor activity. 3) Atezolizumab plus Bevacizumab, which has shown positive results in renal cell carcinoma. 4) Cabozantinib, a tyrosine kinase inhibitor, has shown promise in osteosarcoma and other solid tumors. 5) Regorafenib, which has been effective in metastatic osteosarcoma. These therapies have demonstrated safety and efficacy in clinical trials and represent novel treatment options for solid tumor patients.

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Monoclonal Antibodies

ISM3091 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by InSilico Medicine Hong Kong Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 42 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called XL309, either by itself or with another drug called olaparib. It targets people with advanced solid tumors to see if the drug can stop or slow down cancer growth. Researchers are also checking if combining XL309 with olaparib makes it more effective. Olaparib is a type of drug approved for treating various cancers, including ovarian and breast cancer, particularly in patients with certain genetic conditions.

Who is the study for?

This trial is for adults over 18 with advanced breast, ovarian, or prostate cancer that's worsened after standard treatment or when no other therapy is suitable. They must be in relatively good health otherwise, understand the study and agree to participate by signing a consent form.

What is being tested?

ISM3091, a new drug for treating solid tumors, is being tested. The trial has two parts: first finding the right dose and then confirming it's safe and effective. It's an early-stage study (Phase I) involving patients from multiple centers.

What are the potential side effects?

Since ISM3091 is new and this is its first trial in humans, side effects are not yet fully known. However, similar drugs often cause fatigue, nausea, skin reactions or can affect blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation Stage Primary Objectives/Outcome 1

Dose Escalation Stage Primary Objectives/Outcome 2

Dose Escalation Stage Primary Objectives/Outcome 3

+3 more

Secondary study objectives

Dose Escalation Stage Secondary Objectives/Outcome 1

Dose Escalation Stage Secondary Objectives/Outcome 2

Dose Expansion Stage Secondary Objectives/Outcome 1

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Escalation Single Agent EvaluationExperimental Treatment1 Intervention

Patients will receive XL309 once daily in sequential cohorts of increasing doses.

Group II: Dose Escalation Combination TherapyExperimental Treatment2 Interventions

Patients will receive XL309 once daily in sequential cohorts of increasing dose in combination with olaparib.

Group III: Cohort Expansion Stage Single Agent EvaluationExperimental Treatment1 Intervention

The recommended dose as determined in the Escalation Stage will be further studied in advanced solid tumor-specific cohorts.

Group IV: Cohort Expansion Stage Combination Therapy EvaluationExperimental Treatment2 Interventions

The recommended dose as determined in the Escalation Stage will be further studied in combination with olaparib in advanced solid tumor-specific cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Do I qualify?Apply below to find out

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 often include targeted therapies and combination therapies. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), work by specifically inhibiting pathways that are crucial for tumor cell growth and survival. For example, XL309 is being studied for its potential to inhibit specific molecular targets involved in tumor progression. Combination therapies, such as the use of XL309 with olaparib, a PARP inhibitor, aim to enhance antitumor activity by attacking the cancer cells through multiple mechanisms simultaneously. These approaches are significant for solid tumor patients as they can potentially improve treatment efficacy, reduce tumor resistance, and offer more personalized treatment options, leading to better outcomes and quality of life.