A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants with Select Epithelial Solid Tumours Under Multiple Sub-protocols (ATTEST)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516722-59-00

Acronym

ATTR-01-01

Enrollment

Registered

2025-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-09

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

Conditions

Select Epithelial Solid Tumours

Brief summary

Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments, Objective Response Rate (ORR) from first scan onwards, per RECIST V1.1, Duration of Response (DoR)

Detailed description

Per RECIST V1.1 from first scan onwards: • Disease Control Rate (DCR), Per RECIST V1.1 from first scan onwards: • Time To Response (TTR), Per RECIST V1.1 from first scan onwards: • Progression Free Survival (PFS), Per RECIST V1.1 from first scan onwards: • Overall Survival (OS), Per RECIST V1.1 from first scan onwards: • Maximum reduction in tumour size, SP A only: • ORR from first scan onwards, per RECIST V1.1, SP A only: • Duration of Response (DoR), ATTR-01 viral persistence/blood concentrations, ATTR-01 immunogenicity/anti-ATTR-01 antibodies

Interventions

DRUGATTR-01

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments, Objective Response Rate (ORR) from first scan onwards, per RECIST V1.1, Duration of Response (DoR)	—

Secondary

Measure	Time frame
Per RECIST V1.1 from first scan onwards: • Disease Control Rate (DCR), Per RECIST V1.1 from first scan onwards: • Time To Response (TTR), Per RECIST V1.1 from first scan onwards: • Progression Free Survival (PFS), Per RECIST V1.1 from first scan onwards: • Overall Survival (OS), Per RECIST V1.1 from first scan onwards: • Maximum reduction in tumour size, SP A only: • ORR from first scan onwards, per RECIST V1.1, SP A only: • Duration of Response (DoR), ATTR-01 viral persistence/blood concentrations, ATTR-01 immunogenicity/anti-ATTR-01 antibodies	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

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