Clinical Trials in Australia / NCT07115043
Recruiting
Phase 1/2
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
NCT07115043 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
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
Investigational drug(s) / intervention(s)
AZD6750rilvegostomig →
AZD6750: AZD6750- CD8 guided IL-2
rilvegostomig: Rilvegostomig- PD1-TIGIT bispecific antibody
Study summary
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Eligibility
Inclusion criteria:
* Participant ≥ 18 year
* 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
* 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). Participants with actionable tumor alterations should have received targeted therapy if locally available OR
2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Dose Expansion
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1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
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) 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
Primary outcome measure(s)
- 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.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Grand Rapids | Michigan | Recruiting |
| Research Site | St Louis | Missouri | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | San Antonio | Texas | Recruiting |
| Research Site | Fairfax | Virginia | Recruiting |
| Research Site | East Melbourne | Australia | Recruiting |
| Research Site | Chūōku | Japan | Recruiting |
| Research Site | Kashiwa | Japan | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
More AstraZeneca trials in Australia
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07115043 on ClinicalTrials.gov ↗ ← All trials in Australia