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S095029 + Sym021 for Colorectal Cancer

Phase 1

Waitlist Available

Led By Nehal Lakhani MD, MD, PhD

Research Sponsored by Institut de Recherches Internationales Servier

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 through study completion, up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer treatment.

Who is the study for?

This trial is for adults with advanced solid tumors, including metastatic HER2+ gastric and colorectal cancers. Participants must have tried standard treatments without success or be intolerant to them. They need good heart, liver, kidney, and blood function and can't have had major surgery recently or suffer from active infections or certain chronic conditions.Check my eligibility

What is being tested?

The study tests S095029 alone and combined with Sym021 in patients with various solid tumors. It will expand to test triple combinations involving anti-HER2 therapy (futuximab/modotuximab) specifically in those with metastatic gastric or colorectal cancers.See study design

What are the potential side effects?

While the specific side effects are not listed here, typical reactions may include skin rashes due to prior treatments, issues related to organ functions like the heart (ejection fraction changes), liver (hepatic problems), kidneys (renal function), as well as potential gastrointestinal abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 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

Adverse Events (AEs) (Dose escalation part)

Assessment of antitumor activity using RECIST v1.1 (Dose expansion part)

Incidence of dose limiting toxicities (DLTs) (Dose escalation part)

Secondary outcome measures

Clinical Benefit Rate (CBR) (Dose escalation and dose expansion parts)

Duration of response (DOR) (Dose escalation and dose expansion parts)

Objective Response Rate (Dose escalation part)

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose expansion 2b: S095029 and Sym021 and futuximab/modotuximabExperimental Treatment1 Intervention

Group II: Dose expansion 2a: S095029 and Sym021 and anti-HER2 therapyExperimental Treatment1 Intervention

Group III: Dose escalation 1b: S95029 and Sym021Experimental Treatment1 Intervention

Group IV: Dose escalation 1a: S95029Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor

86 Previous Clinical Trials

67,085 Total Patients Enrolled

ADIR, a Servier Group companyIndustry Sponsor

32 Previous Clinical Trials

4,365 Total Patients Enrolled

Nehal Lakhani MD, MD, PhDPrincipal InvestigatorDirector of Clinical Research START Midwest

Media Library

Solid Tumors Clinical Trial 2023: S095029 Highlights & Side Effects. Trial Name: NCT05162755 — Phase 1

Frequently Asked Questions

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

Is this a trailblazing study in its field?

"Research on S095029 has been conducted since 2021, when ADIR (a Servier Group company) sponsored its first trial with 129 participants. After successfully completing Phase 1 of the drug approval process in that same year, there is currently one live trial for this particular medication being led by ADIR's researchers."

Answered by AI

How many participants have been accepted into this research endeavor?

"Affirmative. Clinicaltrials.gov corroborates that this research is in the process of selecting participants. Its inception was on October 15th 2021 and its latest update came April 27th 2022. This investigation requires 129 patients from 5 clinical centres to take part."

Answered by AI

How many facilities are hosting this clinical trial?

"This clinical trial is presently operational at 5 medical centres, including three cities in Texas and two additional locations. To minimize any inconvenience during the study period, it's suggested to choose a site nearest your location."

Answered by AI

Could you give a synopsis of the other investigations conducted with S095029?

"S095029 was initially researched during 2021 at START Midwest, and since then 5 studies have been concluded. This year, there is a single live trial of it taking place in Houston, Texas."

Answered by AI

Are investigators currently enrolling participants for this trial?

"Affirmative, this clinical trial is currently recruiting participants. The investigation was initially announced on October 15th 2021 and the information contained in it has been recently revised as of April 27th 2022."

Answered by AI