Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4956 · 1 trial · 1 indication
To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).
PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participants withdraw from study treatment or receive another anti-cancer therapy prior to progression.
To assess the safety and tolerability of AZD4956 monotherapy and in combination with anti-cancer agent(s).
| Arm | Type | Description |
|---|---|---|
| Module 1 Part A: AZD4956 monotherapy (Dose escalation) | EXPERIMENTAL | Participants will receive AZD4956 as monotherapy at ascending dose levels. |
| Module 2 Part A: AZD4956 + saruparib (Dose escalation) | EXPERIMENTAL | Participants will receive AZD4956 at ascending dose levels in combination with saruparib. |
| Module 2 Part A Optional PD backfill cohort: AZD4956 + saruparib | EXPERIMENTAL | Participants will receive AZD4956 in combination with saruparib. |
| Module 2 Part A Optional PD backfill cohort: Saruparib monotherapy | EXPERIMENTAL | Participants will receive saruparib monotherapy. |
| Module 2 Part A Optional non-PD backfill cohort: AZD4956 + saruparib | EXPERIMENTAL | Participants with metastatic castrate resistant prostate cancer (mCRPC) will receive AZD4956 in combination with saruparib. |
| Module 2 Part B: AZD4956 + saruparib (Dose expansion) | EXPERIMENTAL | Participants will receive AZD4956 in combination with saruparib. |
| Name | Type | Description |
|---|---|---|
| AZD4956 | DRUG | AZD4956 will be administered orally. |
| Saruparib | DRUG | Saruparib will be administered orally. |
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. * ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
AZD4956 is an investigational small molecule developed by AstraZeneca PLC for the treatment of solid tumours. It is being studied as a monotherapy and in combination with other anti-cancer agents in patients with advanced or metastatic homologous recombination deficient solid tumours. It is currently in Phase 1 clinical development and has not been approved for any indication.
AZD4956 is being evaluated for advanced or metastatic homologous recombination deficient solid tumours. The Phase 1 study enrolls adults with these biomarker-selected cancers and tests AZD4956 both alone and combined with other anti-cancer agents. It remains investigational, so it is not yet an approved treatment option for solid tumours.
AZD4956 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical program evaluating the compound in advanced and metastatic homologous recombination deficient solid tumours across multiple countries.
AZD4956 is in Phase 1 clinical development. The single registered trial is a Phase 1 study that is currently recruiting participants. Because it is still in early-stage testing, AZD4956 is investigational and has not received regulatory approval for any indication.
AZD4956 is being studied in one Phase 1 trial, NCT07446855, titled a study of AZD4956 as monotherapy and in combination with anti-cancer agents in participants with advanced or metastatic homologous recombination deficient solid tumours. The trial is recruiting, plans to enroll 180 participants, and runs in the United States, Australia, Japan, South Korea, Spain, and the United Kingdom.
Yes. The AZD4956 Phase 1 trial enrolls patients with homologous recombination deficient solid tumours, so enrollment is restricted to a biomarker-defined population. The study is controlled and randomized, and participants receive either AZD4956 as monotherapy or AZD4956 in combination with other anti-cancer agents.