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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
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 moreSecondary study objectives
Dose Escalation Stage Secondary Objectives/Outcome 1
Dose Escalation Stage Secondary Objectives/Outcome 2
Dose Expansion Stage Secondary Objectives/Outcome 1
+1 moreAwards & 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
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.
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Who is running the clinical trial?
InSilico Medicine Hong Kong LimitedLead Sponsor
8 Previous Clinical Trials
669 Total Patients Enrolled
ExelixisLead Sponsor
121 Previous Clinical Trials
19,781 Total Patients Enrolled