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Anti-tumor antibiotic

Dose Escalation for Cancer

Phase 1

Recruiting

Research Sponsored by Servier Bio-Innovation LLC

Eligibility Criteria Checklist

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

Must have

ECOG PS 0-1

Participants with histologically confirmed advanced or metastatic solid tumors (excluding central nervous system tumors) that have progressed despite at least one prior treatment regimen given for advanced/metastatic disease, and for whom additional effective standard therapy is not available

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the end of the study (approximately 2 years)

Awards & highlights

Study Summary

This trial is testing a new drug called S095035 in adults with advanced solid tumors. The drug is for those who have a specific genetic mutation and have not responded to standard treatments. S095035

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors missing the MTAP gene, who've tried at least one treatment without success and have no other standard options left. They should be in relatively good health (ECOG PS 0-1), expect to live at least three more months, can use effective birth control, and are willing to provide tumor tissue samples.Check my eligibility

What is being tested?

The study tests S095035, an oral drug designed to inhibit a specific enzyme linked with cancer growth in patients whose tumors lack the MTAP gene. It's an early-stage trial where researchers gradually increase doses to find safe levels.See study design

What are the potential side effects?

As this is a first-in-human study of S095035, detailed side effects aren't yet known but may include typical reactions related to cancer drugs such as nausea, fatigue, liver issues, and potential blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My advanced cancer has worsened despite treatment, and no standard therapy options are left.

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My tumor has a confirmed MTAP deletion based on a specific genetic test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the end of the study (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the end of the study (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the end of the study (approximately 2 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose limiting toxicities (DLTs) associated with S095035 administration during the first cycle of treatment

Total number of adverse events (AEs)

Total number of serious adverse events (SAEs)

Secondary outcome measures

AUC from 0 to infinity (AUC0-∞)

AUC over 1 dosing interval at steady state (AUCtau,ss)

Apparent clearance (CL/F)

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Servier Bio-Innovation LLCLead Sponsor

6 Previous Clinical Trials

630 Total Patients Enrolled

Institut de Recherches Internationales ServierOTHER

86 Previous Clinical Trials

67,109 Total Patients Enrolled

Frequently Asked Questions

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

What are the risks associated with increasing medication dosage for individuals?

"Due to the limited amount of data supporting safety and efficacy, our team at Power rates Dose Escalation with a score of 1 on the scale from 1 to 3. This is in line with it being a Phase 1 trial."

Answered by AI

What is the current number of participants involved in this clinical investigation?

"To meet the trial's requirements, 27 eligible participants are needed. Individuals from various regions like NEXT Oncology in Austin, Texas and Scientia Clinical Research in Randwick, New South Wales can join this research endeavor."

Answered by AI

Is this clinical trial currently open for enrollment?

"As per the details on clinicaltrials.gov, this investigation is currently in search of potential participants. The trial was initially listed on 4/29/2024 and last revised on 4/30/2024."

Answered by AI

At how many different sites is this medical study currently being administered?

"Patients can enroll in this study at NEXT Oncology in Austin, Texas, Scientia Clinical Research in Randwick, New South Wales, and The Alfred in Prahran, Victoria. Additionally, recruitment is ongoing at 5 other undisclosed sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

2024. "S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188702.

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