A first-in-human, open-label, multicenter Phase I/II study to evaluate the safety and anti-tumor activity of ANV600 as single agent and in combination with pembrolizumab in participants with advanced solid tumors (EXPAND-1)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509633-39-00

Acronym

ANV600-001

Enrollment

194

Registered

2024-07-17

Start date

2024-08-06

Completion date

Unknown

Last updated

2025-07-29

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

Conditions

Advanced solid tumours

Brief summary

Phase I: Incidence of dose limiting toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab., Phase I: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab., Phase II: Objective response rate (ORR) using RECIST v1.1., Phase II: Duration of response (DOR) using RECIST v1.1.

Detailed description

Phase I: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing., Phase I: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb)., Phase I: ORR using RECIST v1.1., Phase I: DOR using RECIST v1.1., Phase II: Progression-free Survival (PFS)., Phase II: Overall survival (OS)., Phase II: Frequency and severity of TEAEs with ANV600 and in combination with pembrolizumab., Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing., Phase II: Immunogenicity as indicated by the incidence of ADA and nAb.

Interventions

DRUGANV600

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I: Incidence of dose limiting toxicities (DLT) with ANV600 single agent and in combination with pembrolizumab., Phase I: Frequency and severity of treatment-emergent adverse events (TEAEs) with ANV600 and in combination with pembrolizumab., Phase II: Objective response rate (ORR) using RECIST v1.1., Phase II: Duration of response (DOR) using RECIST v1.1.	—

Secondary

Measure	Time frame
Phase I: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing., Phase I: Immunogenicity as indicated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (nAb)., Phase I: ORR using RECIST v1.1., Phase I: DOR using RECIST v1.1., Phase II: Progression-free Survival (PFS)., Phase II: Overall survival (OS)., Phase II: Frequency and severity of TEAEs with ANV600 and in combination with pembrolizumab., Phase II: PK parameters based on ANV600 serum levels following a single dose and after repeated dosing., Phase II: Immunogenicity as indicated by the incidence of ADA and nAb.	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Netherlands, Spain

Outcome results

None listed

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