Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants
The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced/metastatic solid tumo
| Condition(s) | Solid Tumours |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this modular, first trial in human study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of ascending dose levels (DLs) of AZD4956 monotherapy and in combination with other anti-cancer agents in participants with advanced/metastatic solid tumours with homologous recombination repair (HRR) deficiencies. |
| Who can participate | Core Inclusion Criteria: * Documented locally advanced or metastatic solid tumour malignancy. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to screening and first day of dosing. * Minimum life expectancy ≥ 12 weeks. * Adequate organ and marrow function. * Female participants must not breastfeed and must not donate or retrieve ova for their own use from screening to approximately 6 months after the last dose of study intervention. Module 1 Inclusion Criteria: * Demonstrated evidence of disease progression. * Participants must have advanced or metastatic solid tumours. * Participants may have received up to one prior line of therapy with a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi)-based re |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | New York, New York, United States; Providence, Rhode Island, United States; Houston, Texas, United States; Fairfax, Virginia, United States; Melbourne, Australia; Westmead, Australia (+12 more sites) |
| Start date | 2026-03-17 |
| NCT ID | NCT07446855 |
| Official listing | https://clinicaltrials.gov/study/NCT07446855 |