A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD9793, a T cell-engaging Antibody Targeting Glypican-3 (GPC3) in Adult Participants with Advanced or Metastatic Solid Tumours (RHEA-1)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516698-56-00

Enrollment

Registered

2026-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-03

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

Conditions

Hepatocellular Carcinoma

Brief summary

Incidence of DLTs (only for Dose Escalation)., Incidence of AEs, SAEs, and AESIs., Objective Response Rate (ORR) (For dose expansion only)

Detailed description

Objective Response Rate (ORR) (For dose escalation only), Best overall response (BOR), Disease Control Rate (DCR) at 12 weeks, Durable response rate (DRR), Duration of response (DoR), Time To Response (TTR), % change in tumour size, Progression free Survival (PFS), Overall Survival (OS) [Dose expansion only], Pharmacokinetics of AZD9793: Maximum serum concentration of the study drug (Cmax), serum concentrations of AZD9793, Area Under the concentration-time curve (AUC), Clearance, Terminal elimination half-life (t1/2), Number and percentage of participants who develop ADAs, measured in serum, CD8+ T cell infiltration in tumours pre- and post- treatment

Interventions

DRUGAZD9793

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of DLTs (only for Dose Escalation)., Incidence of AEs, SAEs, and AESIs., Objective Response Rate (ORR) (For dose expansion only)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) (For dose escalation only), Best overall response (BOR), Disease Control Rate (DCR) at 12 weeks, Durable response rate (DRR), Duration of response (DoR), Time To Response (TTR), % change in tumour size, Progression free Survival (PFS), Overall Survival (OS) [Dose expansion only], Pharmacokinetics of AZD9793: Maximum serum concentration of the study drug (Cmax), serum concentrations of AZD9793, Area Under the concentration-time curve (AUC), Clearance, Terminal elimination half-life (t1/2), Number and percentage of participants who develop ADAs, measured in serum, CD8+ T cell infiltration in tumours pre- and post- treatment	—

Measure

Time frame

—

Outcome results

None listed

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