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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 1 year

Awards & highlights

Study Summary

This trial tests a new drug on humans to find a safe dose and understand how it works.

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.Check my eligibility

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.See study design

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 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants with dose-limiting toxicity (DLTs)

Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAEs)

Secondary outcome measures

AUC from time zero to the time of the dosing interval (AUC0-τ)

Accumulation ratio (AR)

Apparent terminal elimination half-life (t1/2)

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 - Dose optimizationExperimental Treatment1 Intervention

Participants will be randomized to receive one of the two selected dose levels of XL309 once daily determined by Study Review Committee.

Group II: Part 1 - Dose EscalationExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

InSilico Medicine Hong Kong LimitedLead Sponsor

4 Previous Clinical Trials

284 Total Patients Enrolled

ExelixisLead Sponsor

117 Previous Clinical Trials

19,485 Total Patients Enrolled

Frequently Asked Questions

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

Are more participants being sought for this clinical exploration?

"As per the information available on clinicaltrials.gov, enrollment for this medical trial is ongoing and was last updated September 1st 2023. The study's original posting date dates back to August 17th 2023."

Answered by AI

To what extent could patients be at risk during Part 2 - Dose optimization?

"Our team at Power believes that Part 2 - Dose optimization can only be considered a 1 out of 3 on the safety scale given its Phase 1 clinical trial status, which indicates limited data regarding efficacy and safety."

Answered by AI

How many individuals have been accepted into this clinical trial?

"Affirmative. Clinicaltrials.gov contains evidence that this examination is currently recruiting participants since it began on August 17th, 2023 and was most recently updated on September 1st, 2023. This study requires 66 patients to be recruited from two different locations."

Answered by AI

What is the desideratum of this investigation?

"As defined by the trial's sponsor, InSilico Medicine Hong Kong Limited, the principal outcome which will be monitored for a period of approximately one year is Dose-Limiting Toxicity (DLTs). Furthermore, secondary outcomes include Maximum Observed Concentration (Cmax), Time to Reach Maximum Plasma Concentration (Tmax) and Apparent Terminal Elimination Half-Life (t1/2)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of XL309 (ISM3091) in Patients With Advanced Solid Tumors

2023. "Study of XL309 (ISM3091) in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05932862.

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