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A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.
Sponsor: Glenmark Specialty S.A.
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.
Official title: A Phase 1, Open Label First In Human Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor GRC 54276 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Pembrolizumab or Anti-PD-L1 Atezolizumab in Subjects With Advanced Solid Tumors and Lymphomas.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2022-06-28
Completion Date
2027-07-30
Last Updated
2024-07-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (18)
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center
Milwaukee, Wisconsin, United States
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
Krupamayi Hospitals
Aurangabad, Maharashtra, India
PD Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, India
HCG Manavata Cancer Centre
Nashik, Maharashtra, India
Sankalp Hospital
Nashik, Maharashtra, India
Bhaktivedanta Hospital and Research Institute
Thane, Maharashtra, India
AIG Hospitals, (A unit of asian Institute of Gastroenterology)
Hyderabad, Telangana, India
Basavatarakam Indo American Cancer Hospital Research Institute
Hyderabad, Telangana, India
Max Superspeciality Hospital
Delhi, India