ClinicaliQ Trial Snapshot
- Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours — Recruiting • Phase I • Oncology • NCT07446855.
- What is being tested: AZD4956, a novel investigational agent, is being evaluated as both a monotherapy and in combination with established anti-cancer treatments in a first-in-human trial, with assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy across ascending dose levels.
- Patient eligibility overview: The trial enrolls participants with advanced or metastatic solid tumours that have homologous recombination deficiency (HRD), a genetic vulnerability affecting DNA repair capacity, representing a biologically defined patient population likely to benefit from targeted therapy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- 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 regimen (either as a treatment or as maintenance). Module 2 Inclusion Criteria: Part A (AZD4956 in Combination with Saruparib Dose Escalation) and Part A-PD (PD Backfill Cohorts): * Participants must have one of the following conditions- 1. Histologically or cytologically confirmed carcinoma of the breast with recurrent locally advanced or metastatic disease and evidence of a predicted loss of function germline or somatic mutation. 2. Histologically or cytologically confirmed advanced ovarian, fallopian tube, or primary peritoneal cancer. 3.…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.