Skip to content

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants with Advanced or Metastatic Solid Malignancies.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502759-70-01
Acronym
D6900C00001
Enrollment
97
Registered
2023-09-19
Start date
2024-02-22
Completion date
Unknown
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer, biliary tract carcinoma, ovarian, endometrial cancer, and squamous non-small cell lung cancer.

Brief summary

Incidence of AEs/SAEs, Incidence of DLTs, Changes from baseline in laboratory findings, ECGs and vital signs, Changes in physical examination (including ECOG)

Detailed description

Radiological response evaluated according to RECIST v1.1 - objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS)., Serum concentrations of AZD8205, anti-B7-H4 antibody (INT016) and unconjugated payload (AZ14170132)., Pharmacodynamics (PK) parameters of AZD8205, INT016 and AZ14170132, including but not limited to area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to reach maximum concentration (tmax), clearance and half-life, as data allow., The number and percentage of participants who develop anti-drug antibody (ADAs)., Additional Sub Study 1 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Serum concentrations and PK parameters (where applicable) of rilvegostomig; Incidence of ADAs against rilvegostomig in serum, Additional Sub study 4 secondary endopoints: Plasma concentration and PK parameters of AZD9574 Serum concentrations and PK parameter (where applicable) of rilvegostomig The number and percentage of participants who develop ADAs.

Interventions

DRUGRilvegostomig

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of AEs/SAEs, Incidence of DLTs, Changes from baseline in laboratory findings, ECGs and vital signs, Changes in physical examination (including ECOG)

Secondary

MeasureTime frame
Radiological response evaluated according to RECIST v1.1 - objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS)., Serum concentrations of AZD8205, anti-B7-H4 antibody (INT016) and unconjugated payload (AZ14170132)., Pharmacodynamics (PK) parameters of AZD8205, INT016 and AZ14170132, including but not limited to area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to reach maximum concentration (tmax), clearance and half-life, as data allow., The number and percentage of participants who develop anti-drug antibody (ADAs)., Additional Sub Study 1 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Serum concentrations and PK parameters (where applicable) of rilvegostomig; Incidence

Countries

Belgium, France, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026