Trial Title:
A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.
NCT ID:
NCT05878691
Condition:
Advanced Solid Tumor
Lymphoma
Conditions: Official terms:
Lymphoma
Pembrolizumab
Atezolizumab
Conditions: Keywords:
Solid tumor
Lymphoma
MTD
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GRC 54276
Description:
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.
Arm group label:
GRC 54276
Intervention type:
Drug
Intervention name:
GRC 54276 + Pembrolizumab
Description:
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.
Arm group label:
GRC 54276 with pembrolizumab
Intervention type:
Drug
Intervention name:
GRC 54276 + Atezolizumab
Description:
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.
Arm group label:
GRC 54276 with atezolizumab
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects (≥18 years of age) with histologically or cytologically confirmed advanced,
metastatic, unresectable solid tumors or lymphomas who have previously received
standard systemic therapy or for whom treatment is not accessible, not tolerated or
refused, have progressed after ≥1 of systemic therapies for recurrent/metastatic
disease and who have not received prior therapy targeting HPK1.
2. At least 1 measurable lesion as defined per RECIST 1.1. The target lesion(s)
selected have not been previously treated with local therapy or the target lesion(s)
selected that are within the field of prior local therapy have subsequently
progressed as defined by RECIST 1.1.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 measured within 72
hours of treatment.
4. Predicted life expectancy of ≥3 months.
5. Adequate organ function as indicated by the following laboratory values up to first
dose of study drug: Hemoglobin ≥9.0 g/dL, Absolute neutrophil count ≥1.5 x 109/L,
Serum total bilirubin ≤1.5 x ULN (<3 x ULN for participants with Gilbert syndrome),
AST and ALT ≤2.5 x ULN (≤5 x ULNs for participants with hepatocellular carcinoma or
liver metastases).
6. Adequate renal function as indicated by creatinine clearance of ≥60mL/min calculated
using Cokroft-Gault method.
7. Adequate cardiac function, left ventricular ejection fraction (LVEF) of ≥50% as
assessed by multi-gated acquisition (MUGA) or ultrasound/echocardiography (ECHO).
8. For Part 2, dose expansion cohorts inclusion criteria specific to tumor types will
be updated after completion of Part 1.
Exclusion Criteria:
1. Any condition that, in the opinion of the Investigator, would interfere with
evaluation of the study drug or interpretation of subject safety or study results.
2. Subjects with uncontrolled or untreated brain metastasis or leptomeningeal disease.
Subjects with equivocal findings or with confirmed brain metastases are eligible
provided that they are asymptomatic and radiologically stable without the need for
corticosteroid treatment for at least 4 weeks prior to the first dose of study
drug(s)
3. Any active malignancy ≤2 years before the first dose of study drug(s) except for the
specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent (e.g., resected basal or squamous cell
skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or
breast)
4. Any condition that required systemic treatment with either corticosteroids (>10 mg
daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days
before the first dose of study drug(s), with the following exceptions:
1. Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
2. Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid
with minimal systemic absorption
3. Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for
contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g.,
delayed-type hypersensitivity reaction caused by contact allergen)
5. Pregnant/planning to be pregnant or breast-feeding women.
6. Any important medical illness or abnormal laboratory finding that would increase the
risk of participating in this study (based on the investigator's judgment).
7. Any known severe allergic reaction to pembrolizumab/atezolizumab or its excipients.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Carolina BioOncology Institute
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Facility:
Name:
Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center
Address:
City:
Milwaukee
Zip:
53226-1222
Country:
United States
Facility:
Name:
Hcg City Cancer Centre
Address:
City:
Vijayawada
Zip:
520002
Country:
India
Facility:
Name:
Mahatma Gandhi Cancer Hospital and Research Institute
Address:
City:
Visakhapatnam
Zip:
530017
Country:
India
Facility:
Name:
Artemis Hospital
Address:
City:
Gurgaon
Zip:
122001
Country:
India
Facility:
Name:
Health Care Global Enterprises Ltd (HCG)
Address:
City:
Bangalore
Zip:
5600027
Country:
India
Facility:
Name:
Vydehi Hospital
Address:
City:
Bangalore
Zip:
560066
Country:
India
Facility:
Name:
Cytecare Hospitals Pvt Ltd.
Address:
City:
Bengaluru
Zip:
560064
Country:
India
Facility:
Name:
Aster CMI Hospital
Address:
City:
Bengaluru
Zip:
560092
Country:
India
Facility:
Name:
Malabar Cancer Centre
Address:
City:
Kannur
Zip:
670103
Country:
India
Facility:
Name:
Krupamayi Hospitals
Address:
City:
Aurangabad
Zip:
431001
Country:
India
Facility:
Name:
PD Hinduja Hospital and Medical Research Centre
Address:
City:
Mumbai
Zip:
400052
Country:
India
Facility:
Name:
HCG Manavata Cancer Centre
Address:
City:
Nashik
Zip:
422002
Country:
India
Facility:
Name:
Sankalp Hospital
Address:
City:
Nashik
Zip:
422009
Country:
India
Facility:
Name:
Bhaktivedanta Hospital and Research Institute
Address:
City:
Thāne
Zip:
401107
Country:
India
Facility:
Name:
AIG Hospitals, (A unit of asian Institute of Gastroenterology)
Address:
City:
Hyderabad
Zip:
500032
Country:
India
Facility:
Name:
Basavatarakam Indo American Cancer Hospital Research Institute
Address:
City:
Hyderabad
Zip:
500034
Country:
India
Facility:
Name:
Max Superspeciality Hospital
Address:
City:
Delhi
Zip:
110017
Country:
India
Start date:
June 28, 2022
Completion date:
July 30, 2027
Lead sponsor:
Agency:
Glenmark Specialty S.A.
Agency class:
Industry
Source:
Glenmark Specialty S.A.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05878691
