A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

AstraZeneca

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Melanoma; Squamous Cell Carcinoma (Skin); Non-small Cell Lung Cancer; Gastric Cancer/Gastroesophageal Junction Cancer; Triple Negative Breast Cancer; Renal Cell Carcinoma; High Grade Serous Ovarian Carcinoma; Head and Neck Squamous Cell Carcinoma; Merkel Cell Carcinoma

Treatments: Drug: rilvegostomig; Drug: AZD6750

Study type: Interventional

Funder types: Industry

Identifiers

NCT07115043

D7350C00001

Details and patient eligibility

About

A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

  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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Module 1

Experimental group

Description:

AZD6750 administered intravenously (IV) as a single agent

Treatment:

Drug: AZD6750

Module 2

Experimental group

Description:

AZD6750 given in combination with rilvegostomig (IV)

Treatment:

Drug: AZD6750

Drug: rilvegostomig