Trials / Recruiting
RecruitingNCT05647122
First in Human Study of AZD9592 in Solid Tumors
A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 403 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD9592 | Varying doses of AZD9592 |
| DRUG | Osimertinib | tablets administered orally |
| DRUG | 5-Fluorouracil (5-FU) | IV infusion |
| DRUG | Leucovorin | IV infusion |
| DRUG | Bevacizumab | IV infusion |
Timeline
- Start date
- 2022-12-21
- Primary completion
- 2027-10-06
- Completion
- 2027-10-06
- First posted
- 2022-12-12
- Last updated
- 2026-02-20
Locations
50 sites across 11 countries: United States, Australia, Canada, China, France, Italy, Japan, Malaysia, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05647122. Inclusion in this directory is not an endorsement.