A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination with Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants with Locally Advanced or Metastatic Solid Tumors

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505084-37-00

Acronym

1570-CL-0101

Enrollment

Registered

2024-06-17

Start date

2025-03-17

Completion date

Unknown

Last updated

2025-12-19

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

Conditions

Advanced Solid Tumors

Brief summary

Safety variables (e.g., incidence of DLTs and AEs; change from baseline in laboratory tests, vital signs and ECG)

Detailed description

ORR, DOR, and DCR of ASP1570 as monotherapy and in combination with pembrolizumab or standard therapies per iRECIST and RECIST 1.1, Selected pharmacokinetic parameters of ASP1570 as monotherapy and in combination with pembrolizumab or standard therapies in plasma: Cmax, tmax, AUCtau and Ctrough, Changes in tumor infiltration with CD4/CD8 cells and level of their proliferation (CD4/CD8, Ki67+)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGASP1570

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety variables (e.g., incidence of DLTs and AEs; change from baseline in laboratory tests, vital signs and ECG)	—

Secondary

Measure	Time frame
ORR, DOR, and DCR of ASP1570 as monotherapy and in combination with pembrolizumab or standard therapies per iRECIST and RECIST 1.1, Selected pharmacokinetic parameters of ASP1570 as monotherapy and in combination with pembrolizumab or standard therapies in plasma: Cmax, tmax, AUCtau and Ctrough, Changes in tumor infiltration with CD4/CD8 cells and level of their proliferation (CD4/CD8, Ki67+)	—

Countries

France, Spain

Outcome results

None listed

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