A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
- Conditions
- MelanomaNon-small Cell Lung CancerSquamous Cell Carcinoma (Skin)Renal Cell CarcinomaMerkel Cell CarcinomaTriple Negative Breast CancerHead and Neck Squamous Cell CarcinomaGastric Cancer/Gastroesophageal Junction CancerHigh Grade Serous Ovarian Carcinoma
- Interventions
- Drug: AZD6750
- Registration Number
- NCT07115043
- Lead Sponsor
- AstraZeneca
- Brief Summary
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Module 1 AZD6750 AZD6750 administered intravenously (IV) as a single agent Module 2 AZD6750 AZD6750 given in combination with rilvegostomig (IV) Module 2 rilvegostomig AZD6750 given in combination with rilvegostomig (IV)
- Primary Outcome Measures
Name Time Method Safety- Part 1A & Part 2A (dose escalation) and Part 2B (dose expansion) Measured from the informed consent until Day 90 post-last dose. 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
Efficacy- Part 2B only (dose expansion) 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) To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents.
- Secondary Outcome Measures
Name Time Method Pharmacodynamic- Part 1A & Part 2A (dose escalation) and Part B (dose expansion) 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) 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
Immunogenicity- Part 1A & 2A (dose escalation) and Part 2B (dose expansion) 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). 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
Efficacy (Part 1A and 2A) 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) To assess the preliminary anti-tumor activity of AZD6750 alone and in combination with other anti-cancer agents.
PK Maximum plasma concentration (Cmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion) Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals 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)
PK Area Under Curve (AUC)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion) Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals 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.
PK Time to maximum plasma concentration (tmax)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion) Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals 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.
PK Clearance- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion) Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals 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.
PK Half-life- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion) Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals 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.
PK Minimum observed concentration (Cmin)- Part 1A and Part 2A (dose escalation) and Part 2B (dose expansion) Measured from pre-infusion on Cycle 1 up to Day 28 post last dose on predefined intervals 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.
Trial Locations
- Locations (1)
Research Site
🇯🇵Kashiwa, Japan
Research Site🇯🇵Kashiwa, Japan