A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07115043
This Phase I/II open-label study evaluates the safety, pharmacokinetics, pharmacodynamics, and efficacy of AZD6750, a CD8 guided IL-2 agent, alone and with rilvegostomig in adults with advanced/metastatic solid tumors. Eligible participants are ≥18 years, with ECOG PS 0-1, measurable lesions, and adequate organ function. Specific criteria apply for select solid tumors and NSCLC stages.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
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
Eligibility Criteria
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
-
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
-
Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.
Dose Expansion
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 49546 | Grand Rapids | Michigan |
| Research Site | 63110 | St Louis | Missouri |
| Research Site | 15232 | Pittsburgh | Pennsylvania |
| Research Site | 77030 | Houston | Texas |
| Research Site | 78229 | San Antonio | Texas |
| Research Site | 22031 | Fairfax | Virginia |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.
