Melanoma NSCLC SCC RCC MCC TNBC H&N SCC GC/GEJC HGSOC
Conditions
Interventions
Module1: AZD6750 administered intravenously (IV) as a single agent
- ZD6750: CD8 guided IL-2
Module2: AZD6750 given in combination with rilvegostomig (IV)
- AZD6750: CD8 guided IL-2
- rilvegostomig
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant 18 year or more - ECOG PS of 0 to 1 - Provision of 'archival' tumor specimen - At least one measurable lesion according to RECIST v1.1, - Minimum life expectancy of 12 weeks - Adequate and stable cardiac function- - Adequate bone marrow, liver and kidney function - Body weight 35 kg or more - Capable of giving signed informed consent Module 1 specific inclusion criteria: - Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer/gastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC Module 2 specific inclusion criteria: - Participants with Stage IV NSCLC Dose Escalation/Backfills 1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). 2. Participants with actionable tumor alterations should have received targeted therapy if locally available OR 1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression 1% or more. Dose Expansion Have not received systemic therapy (1L NSCLC) and have PD-L1 expression 1% or more.
Exclusion criteria
Exclusion criteria: - Any evidence of Severe or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions - History or planned organ or allogeneic stem cell transplantation. - Active or prior documented autoimmune or inflammatory disorders, within the past 3 years - Any prior toxicities that led to permanent discontinuation of prior immunotherapy - Persistent toxicities (CTCAE Grade 2 or more) caused by previous anti-cancer therapy - Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids - Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis. - Active uncontrolled or chronic infection of hepatitis B, hepatitis C - Prior history of Grade >_ 3 non-infectious pneumonitis. - Participant requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent). - Receipt of live attenuated vaccine within 30 days. Module 2 specific exclusion criteria: - Previous treatment with anti-TIGIT therapy - 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Efficacy- Part 2B only (dose expansion) To assess the preliminary anti-tumor activity of AZD6750 in combination with other anti-cancer agents. | — |
Countries
Autralia, Japan, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed