A study to assess the safety and efficacy of AZD7789 in participants with advanced or metastatic solid cancer
- Conditions
- Advanced or Metastatic Non-small Cell Lung CarcinomaSolid TumorsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000036-57-NL
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 81
General Inclusion Criteria for all cohorts:
o Must be = 18 years of age
o Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation
o Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
o Provision of archival or fresh tumor tissue sample and/or consent to undergo mandatory on-treatment biopsy for participants enrolled in Part A Dose-escalation
o Provision of archival tumor tissue sample or fresh tissue sample for Part B Dose-expansion participants
o Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
o Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
o Adequate organ and bone marrow function measured within 28 days prior to first dose
o Part A Dose Escalation Additional Inclusion Criteria:
• May have squamous or non-squamous NSCLC
• Must have received at least one prior line of systemic therapy, of which at least one prior line of therapy contained approved anti-PD-1/PD-L1
• Must have had immune-oncology (IO) acquired or primary resistance
• PD-L1 expression < 1% or = 1% documented
o Part B Dose Expansion Cohort B1 Additional Inclusion Criteria:
• May have squamous or non-squamous NSCLC
• Must have received at least one prior line of systemic therapy, of which only one prior line of therapy contained approved anti-PD-1/PD-L1
• Must have had IO acquired resistance
• PD- L1 expression = 1% documented
o Part B Dose Expansion Cohort B2 Additional Inclusion Criteria:
• May have squamous or non-squamous NSCLC
• Must not have received prior systemic therapy including IO therapy in the first-line setting
• PD-L1 expression = 50% documented
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
o Patients with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions
o Documented test result for any other known genomic alteration for which a targeted first line therapy is approved per local standard of care (SoC)
o Unresolved toxicities of = Grade 2 from prior therapy
o Any prior = Grade 3 immune-mediated adverse event (imAE) while receiving immunotherapy or any unresolved imAE = Grade 2
o Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
o Symptomatic central nervous system (CNS) metastasis or leptomeningeal disease
o History of symptomatic and objectively confirmed arterial (including myocardial infarction) or venous thromboembolic event within 6 months prior to the first dose of study intervention
o History of organ transplant or allogenic haematopoietic stem cell transplant
o Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
o History of arrhythmia which is symptomatic or requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
o Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, serious chronic gastrointestinal conditions associated with diarrhea, active non infectious skin disease
o Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.. Some exceptions have been specified in the protocol
o Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
o Major surgical procedure within 28 days prior to the first dose of study intervention or still recovering from prior surgery
o Other invasive malignancy within 2 years prior to screening
o Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
o Previous treatment with anti-TIM-3 therapy in any setting
o Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
o Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable.
o Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention Note: Participants should not receive live vaccine while receiving study intervention and up to 30 days after the last dose of study intervention
o Radiotherapy treatment to the lung within = 4 weeks of the first dose of AZD7789. Palliative bone radiotherapy is allowed if = 2 weeks prior to the first dose of AZD7789.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method