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A Modular, Open Label, Dose Finding Phase 1/2 Clinical Trial in Patients with Solid Tumours to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PTT-4256 (RAISIC-1: Relief of Acidic Immune Suppression In Cancer)

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522944-41-00
Enrollment
25
Registered
2026-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-27

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

Conditions

Solid Tumours

Brief summary

Incidence, nature, and severity of AEs, SAEs, and TEAEs.

Detailed description

• Incidence, nature, and severity of AEs, SAEs, and TEAEs., • Tumour response assessment by cross-sectional imaging: objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression free survival (PFS) as assessed by RECIST v1.1 and/or iRECIST (if applicable) criteria, based on Investigator assessment, • Overall survival (OS) as assessed during study participation and via telephone follow-ups every 3 months thereafter., • Plasma PK parameters, including but not limited to: Cmin, Cmin_ss, and accumulation ratio (RA Cmin).

Interventions

DRUGPTT-4256
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Sponsors

Pathios Therapeutics Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence, nature, and severity of AEs, SAEs, and TEAEs.—

Secondary

MeasureTime frame
• Incidence, nature, and severity of AEs, SAEs, and TEAEs., • Tumour response assessment by cross-sectional imaging: objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression free survival (PFS) as assessed by RECIST v1.1 and/or iRECIST (if applicable) criteria, based on Investigator assessment, • Overall survival (OS) as assessed during study participation and via telephone follow-ups every 3 months thereafter., • Plasma PK parameters, including but not limited to: Cmin, Cmin_ss, and accumulation ratio (RA Cmin).—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 28, 2026