A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination with Axitinib in Subjects with Advanced Renal Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509604-15-00

Enrollment

Registered

2024-06-05

Start date

2021-02-15

Completion date

Unknown

Last updated

2025-11-20

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

Conditions

Advanced Renal Cell Carcinoma

Brief summary

"Safety • Incidence of adverse events (AEs)/serious adverse events (SAEs) • Dose-limiting toxicities (DLTs) • AEs leading to discontinuation of treatment • Abnormal laboratory parameters, vital signs, electrocardiogram (ECG) results Efficacy • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1"

Detailed description

"Efficacy • Progression-free survival (PFS), best overall response (BOR), disease control rate (DCR), duration of response (DoR), and time to response (TTR) per RECIST v1.1 Pharmacokinetics • Concentration of MEDI5752 in serum Immunogenicity • Incidence of antidrug antibodies (ADAs) against MEDI5752 in serum "

Interventions

DRUGLENVIMA 4 mg hard capsules

DRUGvolrustomig

DRUGKisplyx 10 mg hard capsules

DRUGKisplyx 4 mg hard capsules

DRUGLENVIMA 10 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
"Safety • Incidence of adverse events (AEs)/serious adverse events (SAEs) • Dose-limiting toxicities (DLTs) • AEs leading to discontinuation of treatment • Abnormal laboratory parameters, vital signs, electrocardiogram (ECG) results Efficacy • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1"	—

Secondary

Measure	Time frame
"Efficacy • Progression-free survival (PFS), best overall response (BOR), disease control rate (DCR), duration of response (DoR), and time to response (TTR) per RECIST v1.1 Pharmacokinetics • Concentration of MEDI5752 in serum Immunogenicity • Incidence of antidrug antibodies (ADAs) against MEDI5752 in serum "	—

Countries

France, Spain

Outcome results

None listed

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