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ACTIVE NOT RECRUITING
NCT05878691
PHASE1

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

Sponsor: Glenmark Specialty S.A.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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