A randomized non-comparative open-label phase 1b/2 study of nadunolimab in combination with gemcitabine plus carboplatin in patients with advanced triple negative breast cancer “TRIFOUR study”

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512052-38-00

Acronym

CAN04CLIN005

Enrollment

117

Registered

2024-04-10

Start date

2021-12-02

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

Advanced triple negative breast cancer

Brief summary

Phase Ib: To determine the incidence rate of Dose Limiting Toxicity (DLT) within the first Cycle of nadunolimab in combination with GC., Phase II: to evaluate the ORR, defined as the rate of Complete Response (CR) plus Partial Response (PR) according to RECIST version 1.1, out of the patients who receive at least one dose of treatment and have measurable disease. These results will be calibrated against the ORR in the control arm.

Interventions

DRUGGEMCITABINE

DRUGCARBOPLATIN

DRUGCAN04

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase Ib: To determine the incidence rate of Dose Limiting Toxicity (DLT) within the first Cycle of nadunolimab in combination with GC., Phase II: to evaluate the ORR, defined as the rate of Complete Response (CR) plus Partial Response (PR) according to RECIST version 1.1, out of the patients who receive at least one dose of treatment and have measurable disease. These results will be calibrated against the ORR in the control arm.	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

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