Clinical trial · Interventional
A Phase I Study of AZD4635 in Japanese Patients With Advanced Solid Malignancies
A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4635 in Japanese Patients With Advanced Solid Malignancies.
NCT03980821CI-TRIAL-00048683completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase I, open-label study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of AZD4635 in Japanese patients with advanced solid malignancies. This study consists of 2 cohorts, Cohort1 and Cohort2. At least 3 or up to 6 evaluable Japanese patients with advanced solid malignancies will be enrolled in Cohort1 and 6 evaluable patients will be enrolled in Cohort2.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD4635 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD4635 monotherapy
- description
- Dose escalation of AZD4635 monotherapy for patients with advanced solid malignancies
- interventionNames
- Drug: AZD4635
Primary outcomes (2)
- measure
- The incidence of Adverse event and SAE
- timeFrame
- From the informed consent to 30 days post last dose
- description
- Investigate the safety and tolerability of AZD4635
- measure
- The incidence of Dose-limiting toxicity (DLTs)
- timeFrame
- 25 days (Cycle0 and Cycle1)
- description
- Investigate the safety and tolerability of AZD4635
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Major Inclusion Criteria: * Adult subjects; age ≥ 20 years * Histologically or cytological confirmation of a solid, malignant tumor, excluding central nervous system (CNS) tumors and lymphoma, that is refractory to standard therapy or for which no standard of care regimen currently exists * Patients must have either at least one lesion that can be evaluable using RECIST v1.1 or patients with mCRPC must have measurable prostate specific antigen above normal limits (per local ranges) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Normotensive or well controlled blood pressure, with or without current antihypertensive treatment * Females of child-bearing potential must use 2 highly effective methods of contraception * Male patients should be willing to use barrier contraception Major Exclusion Criteria: * Any investigational medicinal product or other systemic anticancer treatment within at least 4 weeks prior to the first dose of study treatment, or within 8 weeks after immunotherapy or other long half-life antibody therapy, whichever is the most appropriate and as judged by the Investigator. * Evidence of recent or significant cardiovascular disease * Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at starting study treatment * History of seizures, CNS tumors or CNS metastasis * Active or prior documented autoimmune or inflammatory disorders within the past 3 years to the start of treatment * Patients with prior ≥ Grade3 immune-mediated reactions * Evidence of severe or uncontrolled systemic diseases * Inadequate bone marrow reserve or organ function * Refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of AZD4635 * History of hypersensitivity to AZD4635 or drugs with a similar chemical structure or class to AZD4635 * Judgment by the Investigator that the patient should not participate in the study
References
Publications (1)
- DERIVEDMatsubara N, Kusuhara S, Yamamoto N, Sudo K, Yanagita M, Murayama K, Kawasumi H, Russell DL, Yin D, Shimizu T. Safety and pharmacokinetics of imaradenant (AZD4635) in Japanese patients with advanced solid malignancies: a phase I, open-label study. Cancer Chemother Pharmacol. 2024 Apr;93(4):341-352. doi: 10.1007/s00280-023-04605-9. Epub 2023 Dec 13. PMID 38086998