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NCT05878691 · ClinicalTrials.gov registry record · Phase 1
A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.
A Phase 1 study of Lymphoma and Advanced Solid Tumor, sponsored by Glenmark Specialty S.A..
- Active
- Registry status
- Phase 1
- Development phase
- 320
- Enrollment target
- 18
- Study locations
NCT05878691: Active Phase 1 study of Lymphoma and Advanced Solid Tumor, sponsored by Glenmark Specialty S.A..
NCT05878691 is a Phase 1 study of Lymphoma and Advanced Solid Tumor that is active but no longer recruiting, run by Glenmark Specialty S.A.. The registered enrollment target is 320 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (34% lower). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05878691, a Phase 1 study of Lymphoma and Advanced Solid Tumor, is active but no longer recruiting, sponsored by Glenmark Specialty S.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 320 participants
- Enrollment target
- 18
- Study locations
Study Summary
This is first in human (FIH) study to a) evaluate the safety and tolerability profile of GRC54276, b) determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D), and c) pharmacokinetic profile of GRC54276 alone and in combination with pembrolizumab or atezolizumab in participants with advanced solid tumors and lymphomas.
Primary Outcome
Percentage of participants with dose limiting toxicities associated with GRC54276 alone or GRC54276 combined with pembrolizumab or atezolizumab during the first cycle. Toxicity will be assessed using the NCI CTCAE Version 5.0.
Conditions Studied
Interventions
- DRUG GRC 54276
- DRUG GRC 54276 + Pembrolizumab
- DRUG GRC 54276 + Atezolizumab
Study Locations (18)
Maharashtra
- Krupamayi Hospitals - Aurangabad
- PD Hinduja Hospital and Medical Research Centre - Mumbai
- HCG Manavata Cancer Centre - Nashik
- Sankalp Hospital - Nashik
- Bhaktivedanta Hospital and Research Institute - Thane
Karnataka
- Health Care Global Enterprises Ltd (HCG) - Bangalore
- Vydehi Hospital - Bangalore
- Cytecare Hospitals Pvt Ltd. - Bengaluru
- Aster CMI Hospital - Bengaluru
Andhra Pradesh
- Hcg City Cancer Centre - Vijayawada
- Mahatma Gandhi Cancer Hospital and Research Institute - Visakhapatnam
Telangana
- AIG Hospitals, (A unit of asian Institute of Gastroenterology) - Hyderabad
- Basavatarakam Indo American Cancer Hospital Research Institute - Hyderabad
North Carolina
- Carolina BioOncology Institute - Huntersville
Wisconsin
- Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center - Milwaukee
Haryana
- Artemis Hospital - Gurgaon
Kerala
- Malabar Cancer Centre - Kannur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 1 |
What the registry record for NCT05878691 still lists
NCT05878691 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (34% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which GRC 54276 is the first listed.
NCT05878691 lists 18 locations in 9 states (Maharashtra, Karnataka, Andhra Pradesh).
Frequently Asked Questions
What is clinical trial NCT05878691 about?
NCT05878691 is a clinical study titled "A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.". This is first in human (FIH) study to a) evaluate the safety and tolerability profile of GRC54276, b) determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D), and c) pharmacokinetic profile of GRC54276 alone and in combination with pembrolizumab or atezolizumab in participant...
What is the current status of trial NCT05878691?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 320 participants. The study started on 2022-06-28. Estimated completion is 2027-07-30.
What conditions does trial NCT05878691 study?
This clinical trial studies the following conditions: Lymphoma, Advanced Solid Tumor.
What interventions are being tested in trial NCT05878691?
The interventions under investigation include: GRC 54276 (DRUG), GRC 54276 + Pembrolizumab (DRUG), GRC 54276 + Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT05878691?
This trial is sponsored by Glenmark Specialty S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05878691 being conducted?
This trial has 18 study locations across North Carolina, Wisconsin, Andhra Pradesh, Haryana, Karnataka. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05878691's enrollment target sits among peer trials
320 30th of 299 higher than 270 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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