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DRUG:

GRC 54276

i
Associations
Trials
Company:
Glenmark
Drug class:
HPK1 inhibitor
Associations
Trials
5ms
A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas. (clinicaltrials.gov)
P1, N=320, Active, not recruiting, Glenmark Specialty S.A. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
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Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • GRC 54276
over1year
New P1 trial • Combination therapy • Metastases
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Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • GRC 54276
over1year
PHASE 1 FIRST IN HUMAN STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF GRC54276, A NOVEL HPK1 THRONINE- KINASE INHIBITOR, IN ADVANCED SOLID TUMOURS AND LYMPHOMAS. (EHA 2023)
GRC54276 has been well tolerated at the dose levels tested and has shown antitumor activity when administered as monotherapy to Hodgkin's lymphoma, colon carcinoma and buccal mucosal carcinoma patients. GRC54276 will be further tested in select patients as monotherapy and in combination with pembrolizumab or atezolizumab. Lymphoma, Targeted therapy, Hodgkin's lymphoma, Cancer immunotherapy
Clinical • P1 data • PK/PD data • Metastases
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BLNK (B Cell Linker) • LCP2 (Lymphocyte cytosolic protein 2)
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Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • GRC 54276
almost3years
IND-ready clinical candidate for HPK1 developed with excellent efficacy and safety profile (AACR 2022)
In vivo efficacy was demonstrated in syngeneic mouse tumor models, both as a single agent and combination with immune check-point blockers (ICB), mouse anti-CTLA4 antibody or Atezolizumab (human anti-PD-L1 antibody). The no observed adverse effect levels in the 14-day and 17-day exploratory studies in mice and monkeys were 50 and 15 mg/kg/day, respectively.Conclusions GRC 54276, our clinical candidate is potent, selective, orally bioavailable HPK1 inhibitor demonstrating strong single-agent and combination efficacy, low DDI liability accompanied by acceptable early safety profile in mice and monkeys. GRC 54276 is undergoing IND enabling studies to advance to Phase 1 clinical trial.
Clinical
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IFNG (Interferon, gamma) • IL2 (Interleukin 2) • CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
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Tecentriq (atezolizumab) • GRC 54276