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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
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.
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.
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.
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center
Milwaukee, Wisconsin, United States
Dose limiting toxicities to establish the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
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.
Time frame: 18 weeks
Incidence of treatment-emergent adverse events and serious adverse events
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.
Time frame: up to 120 days
Changes in the laboratory safety values from baseline to end of safety follow-up
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.
Time frame: up to 120 days
Pharmacokinetic profile of GRC54276- Maximum plasma concentration (Cmax)
The maximum measured plasma concentration after single or multiple dosing, tabulated by dose group and day of dosing.
Time frame: up to 22 days
Pharmacokinetic profile of GRC54276- Time to Cmax (Tmax)
The time to achieve Cmax after single or multiple dosing, tabulated by dose group and day of dosing.
Time frame: up to 22 days
Pharmacokinetic profile of GRC54276- Area under the curve (AUC)
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.
Time frame: up to 22 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hcg City Cancer Centre
Vijayawada, Andhra Pradesh, India
Mahatma Gandhi Cancer Hospital and Research Institute
Visakhapatnam, Andhra Pradesh, India
Artemis Hospital
Gurgaon, Haryana, India
Health Care Global Enterprises Ltd (HCG)
Bangalore, Karnataka, India
Vydehi Hospital
Bangalore, Karnataka, India
Cytecare Hospitals Pvt Ltd.
Bengaluru, Karnataka, India
Aster CMI Hospital
Bengaluru, Karnataka, India
Malabar Cancer Centre
Kannur, Kerala, India
...and 8 more locations
Objective response rate (ORR)
Proportion of participants with a best response of complete response or partial response best on RECIST 1.1.
Time frame: up to 9 months
Best overall response rate
Complete response, partial response, stable disease, and progressive disease, evaluated according to RECIST 1.1.
Time frame: up to 9 months
Disease control rate
The percentage of participants who have achieved stable disease or complete response or partial response according to RECIST 1.1. for the entire duration of the study.
Time frame: up to 9 months
Duration of response
The time from first documentation of complete response or partial response to the first documentation of progression.
Time frame: up to 9 months