A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic Non-small Cell Lung Cancer

JRCT ID: jRCT2031220297

Registered date:27/08/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-Small-Cell Lung Carcinoma
• Date of first enrollment: 27/08/2022
• Target sample size: 18
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,China,Japan,Denmark,Japan,France,Japan,Netherlands,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,UK,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): AZD2936 750 mg or 1,500 mg IV every 3 weeks

Outcome(s)

Primary Outcome

Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters [Time Frame: Part A, B, C and D: From the time of informed consent until 90 days after the last dose of AZD2936]
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Written informed consent

- Aged 18 or above

- Part A: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation.

- Documented PD-L1 expression by PD-L1 IHC per local report.

- Part A : Confirmed progression during treatment with a CPI-including regimen.

- Part C and Part D: No prior I/O treatment for metastatic NSCLC.

- ECOG performance status of 0 or 1 at enrolment.

- Life expectancy of 12 weeks or more at enrolment.

- Have at least 1 measurable lesion per RECIST v1.1.

- Adequate bone marrow, liver and kidney function

Exclude criteria

- Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion

- Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)

- Previous treatment with an anti-TIGIT therapy

- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.

- Part A : Primary or secondary resistance after treatment with 2 or more regiments including a CPI.

- Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted). Treatment with one previous systemic chemotherapy will be allowed.

- Symptomatic central nervous system (CNS) metastasis.

- Thromboembolic event within 3 months prior to enrolment.

- Other invasive malignancy within 2 years prior to screening.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04995523