A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.
Condition(s) studied
Investigational drug(s) / intervention(s)
GRC 54276: Part 1a: GRC 54276 QD will be administered orally from Day 1 to Day 21 in a 21-day treatment cycle. Part 2: GRC 54276 monotherapy therapy will commence after establishment of the MTD and/or RP2D for monotherapy arm.
GRC 54276 + Pembrolizumab: Part 1b: GRC 54276 QD will be administered orally in combination with fixed dose of pembrolizumab IV every 21 days. Part 2: GRC 54276 in combination with pembrolizumab will commence after establishment of the MTD and/or RP2D for combination therapy arm.
GRC 54276 + Atezolizumab: Part 1b: GRC 54276 QD will be administered orally in combination with fixed dose of atezolizumab IV every 21 days. Part 2: GRC 54276 in combination with atezolizumab will commence after establishment of the MTD and/or RP2D for combination therapy arm.
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.
Eligibility
Primary outcome measure(s)
- Dose limiting toxicities to establish the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) — 18 weeks
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. - Incidence of treatment-emergent adverse events and serious adverse events — up to 120 days
Percentage of participants who experience treatment-emergent adverse events and serious adverse events when given GRC54276 as a single agent and in combination with pembrolizumab or atezolizumab. - Changes in the laboratory safety values from baseline to end of safety follow-up — up to 120 days
Percentage of participants who experience changes in the laboratory safety values when given GRC54276 as a single agent and in combination with pembrolizumab or atezolizumab. - Pharmacokinetic profile of GRC54276- Maximum plasma concentration (Cmax) — up to 22 days
The maximum measured plasma concentration after single or multiple dosing, tabulated by dose group and day of dosing. - Pharmacokinetic profile of GRC54276- Time to Cmax (Tmax) — up to 22 days
The time to achieve Cmax after single or multiple dosing, tabulated by dose group and day of dosing. - Pharmacokinetic profile of GRC54276- Area under the curve (AUC) — up to 22 days
Area under plasma concentration versus time curve from time 0 to time of least measurable concentration or the dosing interval, tabulated by dose group and day of dosing.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Carolina BioOncology Institute | Huntersville | North Carolina | |
| Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center | Milwaukee | Wisconsin | |
| Hcg City Cancer Centre | Vijayawada | Andhra Pradesh | |
| Mahatma Gandhi Cancer Hospital and Research Institute | Visakhapatnam | Andhra Pradesh | |
| Artemis Hospital | Gurgaon | Haryana | |
| Health Care Global Enterprises Ltd (HCG) | Bangalore | Karnataka | |
| Vydehi Hospital | Bangalore | Karnataka | |
| Cytecare Hospitals Pvt Ltd. | Bengaluru | Karnataka | |
| Aster CMI Hospital | Bengaluru | Karnataka | |
| Malabar Cancer Centre | Kannur | Kerala | |
| Krupamayi Hospitals | Chhatrapati Sambhajinagar | Maharashtra | |
| PD Hinduja Hospital and Medical Research Centre | Mumbai | Maharashtra | |
| HCG Manavata Cancer Centre | Nashik | Maharashtra | |
| Sankalp Hospital | Nashik | Maharashtra | |
| Bhaktivedanta Hospital and Research Institute | Thane | Maharashtra | |
| AIG Hospitals, (A unit of asian Institute of Gastroenterology) | Hyderabad | Telangana | |
| Basavatarakam Indo American Cancer Hospital Research Institute | Hyderabad | Telangana | |
| Max Superspeciality Hospital | Delhi | India |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05878691 on ClinicalTrials.gov ↗ ← All trials in India