← Back to Search

Other

GRC 54276 + Immunotherapy for Advanced Cancers

Phase 1

Recruiting

Research Sponsored by Glenmark Specialty S.A.

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 up to 9 months

Awards & highlights

Study Summary

This trial tests a drug's safety and dose to treat advanced cancers, and how it interacts with other drugs.

Who is the study for?

Adults with advanced solid tumors or lymphomas that have progressed after standard treatments, who haven't tried HPK1-targeting therapy. They should be in relatively good health (ECOG ≤1), have a life expectancy of at least 3 months, measurable disease per RECIST 1.1 criteria, and proper organ function including heart and kidneys. Pregnant women, those with severe allergies to trial drugs or their components, uncontrolled brain metastases, recent other cancers or immunosuppressive treatment are excluded.Check my eligibility

What is being tested?

This first-in-human study tests GRC54276 alone and combined with pembrolizumab or atezolizumab in patients with advanced cancer. It aims to find the safest dose for future studies (MTD), decide on Phase 2 doses (RP2D), and understand how the body processes these drugs (pharmacokinetics).See study design

What are the potential side effects?

Potential side effects include allergic reactions to the medications used; however specific side effects of GRC54276 aren't listed as this is a first-in-human study determining safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Changes in the laboratory safety values from baseline to end of safety follow-up

Dose limiting toxicities to establish the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D)

Incidence of treatment-emergent adverse events and serious adverse events

+3 more

Secondary outcome measures

Best overall response rate

Disease control rate

Duration of response

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: GRC 54276 with pembrolizumabExperimental Treatment1 Intervention

Group II: GRC 54276 with atezolizumabExperimental Treatment1 Intervention

Group III: GRC 54276Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Glenmark Specialty S.A.Lead Sponsor

5 Previous Clinical Trials

3,558 Total Patients Enrolled

Adam Y-Beltran, MDStudy DirectorGlenmark Pharmaceuticals Ltd.

Harsha Doddihal, MDStudy DirectorGlenmark Pharmaceuticals Ltd.

Media Library

GRC 54276 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05878691 — Phase 1

Lymphoma Research Study Groups: GRC 54276 with atezolizumab, GRC 54276, GRC 54276 with pembrolizumab

Lymphoma Clinical Trial 2023: GRC 54276 Highlights & Side Effects. Trial Name: NCT05878691 — Phase 1

GRC 54276 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878691 — Phase 1

Frequently Asked Questions

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

Are any volunteers currently being enrolled for this experiment?

"As indicated on the clinicaltrials.gov platform, recruitment for this study is ongoing and has been since its initial posting of June 28th 2022. This information was last updated on May 19th 2023."

Answered by AI

How many volunteers are engaged in this clinical experiment?

"This research study requires 320 eligible volunteers to partake in it. These participants can be found at Artemis Hospital, Gurgaon and HCG Enterprises Ltd., Bangalore - two of the many enrolment sites included in this trial."

Answered by AI

What untoward effects has GRC 54276 been known to cause in human subjects?

"The safety profile of GRC 54276 has been conservatively rated as 1 due to its Phase 1 status, which indicates limited data substantiating both efficacy and safety."

Answered by AI

On what scale is this clinical experiment being conducted?

"At this time, 8 sites across India are accepting enrollees for the trial. These centres are located in Gurgaon, Bangalore, Kannur and other nearby regions. To reduce travel-related costs of participation, it is suggested that those interested choose a location close to them."

Answered by AI

What aims does this research endeavor seek to fulfill?

"This 18-week clinical trial seeks to evaluate the occurrence of treatment-induced adverse effects and serious health issues as its primary outcome. Secondary outcomes include best overall response rate, disease control rate, and duration of response; all categorised according to RECIST 1.1 criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.

2022. "A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878691.