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

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
Glenmark Specialty S.A.
Study ID
NCT05878691
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GRC 54276 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 28, 2022
Status verified
Jul 2024
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GRC 54276
  • Experimental: GRC 54276 with pembrolizumab
  • Experimental: GRC 54276 with atezolizumab

Primary Outcome Measure

Dose limiting toxicities to establish the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) [ Time Frame: 18 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer CenterMilwaukeeWisconsin53226-1222-

Find similar trials in Huntersville, NC

By research site
Carolina BioOncology Institute· Huntersville, NCFroedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center· Milwaukee, WI

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