A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
18 - 130 Years, Male and Female
D9570C00001 (primary)
NCI-2022-01956
152970
2021-000036-57
Summary
This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3
bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with
advanced solid tumors.
Objectives
This first time in patients, open-label, multi-centre study will have AZD7789
administered intravenously (IV) to participants with advanced solid tumors. This study
will have 2 parts: Part A which will have dose escalation cohorts and Part B which will
have the dose expansion cohorts.
Eligibility
- Must be = 18 years of age
- Part A Dose-escalation cohorts and Part B Dose-expansion cohorts B1, B2, B3 and B5: Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation.
- Part B Dose-expansion cohort B4: Histologically or cytologically documented advanced or metastatic gastric and gastro-esophageal junction adenocarcinoma (GEJC) not amenable to curative surgery or radiation.
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- 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
- Provision of archival tumor tissue sample or fresh tissue sample for Part B Dose-expansion cohorts B1, B2, B3 and B5. Provision of fresh tumor tissue sample and consent to undergo mandatory on-treatment biopsy for cohort B4.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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
- Adequate organ and bone marrow function measured within 28 days prior to first dose
- 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
- Part B Dose Expansion Cohort B1 and B3 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
- Part B Dose Expansion Cohort B2 and B5 Additional Inclusion Criteria:
- May have squamous or non-squamous NSCLC
- Must not have received prior IO therapy in the first-line setting, but may have received one prior treatment regime of platinum-based chemotherapy
- Cohort B2: PD-L1 expression = 50% documented
- Cohort B5: PD-L1 expression 1-49% documented
- Part B Dose Expansion Cohort B4 Additional Inclusion Criteria:
- Must have received at least one but no more than two prior lines of systemic therapy, of which only one prior line of therapy contained an approved anti-PD-1/PD-L1
- Must have had IO acquired resistance
- There are no PD-L1 status requirements for this cohort
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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