A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants with Select Advanced or Metastatic Solid Tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
AZD6750- CD8 guided IL-2
Rilvegostomig- PD1-TIGIT bispecific antibody
Research Site
Grand Rapids, Michigan, United States
RECRUITINGResearch Site
St Louis, Missouri, United States
RECRUITINGResearch Site
Pittsburgh, Pennsylvania, United States
RECRUITINGResearch Site
Houston, Texas, United States
RECRUITINGResearch Site
San Antonio, Texas, United States
RECRUITINGResearch Site
Fairfax, Virginia, United States
RECRUITINGResearch Site
East Melbourne, Australia
RECRUITINGResearch Site
Chūōku, Japan
RECRUITINGResearch Site
Kashiwa, Japan
RECRUITINGResearch Site
Seoul, South Korea
NOT_YET_RECRUITING...and 1 more locations
Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the safety and tolerability, characterize the DLTs, and determine the MTD and RP2D(s) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module
Time frame: Measured from the informed consent until Day 90 post-last dose.
Efficacy- Part 2B only (dose expansion)
To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.
Time frame: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or death in the absence of disease progression(approximately 2 years)
Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion)
To assess immunomodulatory biomarker PD-L1 at baseline and on treatment as a single agent and in combination with other anti-cancer agents as specified in each respective module
Time frame: Measured with baseline and On-treatment biopsy. On-treatment biopsy is planned during Cycle 2 during Cycle 2 (each cycle is 28 days or 21 days depending on Module/dosing schedule)
Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion)
To assess the incidence of anti-drug antibodies (ADA) against AZD6750 in serum and in combination with other anti-cancer agents as specified in each respective module
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose. Each cycle is 28 days or 21 days depending on Module/dosing schedule).
Efficacy (Part 1A and 2A)
To assess the preliminary anti-tumor activity of AZD6750 alone and in combination with other anti-cancer agents.
Time frame: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter thereafter from first dose until disease progression or death in the absence of disease progression (approximately 2 years)
PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule)
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the Area Under Curve (AUC) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the time to maximum plasma concentration of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the clearance of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the PK half-time of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 depending on Module/dosing schedule.
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion)
To assess the minimum observed concentration (Cmin) of AZD6750 as a single agent and in combination with other anti-cancer agents as specified in each respective module. Each cycle is 28 days or 21 days depending on Module/dosing schedule.
Time frame: Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals
AstraZeneca Clinical Study Information Center
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