JPRN-jRCT2031220675
Recruiting
Phase 1
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.
Hibi Kazushige0 sites24 target enrollmentMarch 2, 2023
ConditionsAdvanced or Metastatic Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced or Metastatic Solid Tumors
- Sponsor
- Hibi Kazushige
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be 18 or more years of age
- •\- Japan mini dose escalation phase: Histological or cytological confirmation of a solid, malignant tumor refractory to standard therapies or for which no standard therapies exist (Recruiting of Japan mini dose escalation phase has ended).
- •\- Part B Dose Expansion cohorts B2 and B3: Histologically or cytologically documented Stage IIIB to IV non\-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation (Recruiting of cohort B3 has ended).
- •\- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1\.1
- •\- Provision of archival tumor tissue sample or fresh tissue sample for Part B Dose\-expansion cohorts B2 and B3\. 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 B Dose Expansion Cohort B3 Additional Inclusion Criteria:
- •\- May have squamous or non\-squamous NSCLC
Exclusion Criteria
- •\- Part B Dose Expansion: Patients with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions. Documented test result is mandatory for participants with non\-squamous NSCLC histology. For participants with squamous NSCLC histology, testing is mandatory only if the participant is a never\-smoker or in the presence of a mixed histology. (not applicable for the Japan mini dose escalation phase)
- •\- Part B Dose Expansion: Documented test result for any other known genomic alteration for which a targeted first line therapy is approved per local standard of care (SoC) (not applicable for the Japan mini dose escalation phase)
- •\- Part B Dose\-expansion Cohort B4: documented HER2 amplification (unless a SoC including an anti\-HER2 therapy has been received); testing is not mandatory if not required per local guidelines.
- •\- Unresolved toxicities of Grade 2 or more from prior therapy
- •\- Any prior Grade 3 or more immune\-mediated adverse event (imAE) while receiving immunotherapy or any unresolved imAE Grade 2 or more
- •\- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
- •\- Symptomatic central nervous system (CNS) metastasis or leptomeningeal disease
- •\- 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, unless participant is on treatment with adequate antithrombotic medication and is considered to be stable by the Investigator.
- •\- History of organ transplant or allogenic haematopoietic stem cell transplant
- •\- Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID\-19 infection
Outcomes
Primary Outcomes
Not specified
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