NCT04610528: TOT-HER3

A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

Status unknown EARLY_PHASE1 Last updated 23 June 2023

What this trial tests

EARLY_PHASE1 trial testing U3 1402 in Breast Cancer in 80 participants. Status unknown.

Timeline

22 December 2020

Primary endpoint
30 January 2022

30 September 2023

Quick facts

Lead sponsor	SOLTI Breast Cancer Research Group
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	22 December 2020
Primary completion	30 January 2022
Estimated completion	30 September 2023
Sites	10 locations across Spain

Drugs / interventions tested

• U3 1402
• U3 1402

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

SOLTI Breast Cancer Research Group

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, multicenter, single arm, window-of-opportunity study evaluating the biological effect of U3-1402 in treatment naïve patients with early breast cancer, whose primary tumors are ≥1 cm by ultrasound evaluation.

The primary objective is to evaluate the biological activity of U3-1402, measured as the CelTIL score increase at post-treatment (C1D21) in HR+/HER2-negative BC included patients.

The study will consist of 2 parts enrolling \~115 patients.

* Part A will target to treat, with 6.4 mg/kg dose, 80 patients with HR-positive/HER2-negative tumors and
* Part B will target to treat with 5.6 mg/kg dose 20 patients with HR-positive/HER2-negative and 15 patients with TNBC tumors

Part A will test U3-1402 in patients with HR-positive/HER2-negative early breast cancer with a dose of 6.4 mg/kg. Part B will consist in testing 5.6 mg/kg dose of U3-1402 in patients with HR-positive/HER2-negative early breast cancer and in triple-negative early breast cancer and will be performed sequentially after Part A.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody-drug conjugates in solid tumors: a look into novel targets.
   Criscitiello C, Morganti S, Curigliano G. · · 2021 · cited 169× · PMID 33509252 · DOI 10.1186/s13045-021-01035-z
2. Payload diversification: a key step in the development of antibody-drug conjugates.
   Conilh L, Sadilkova L, Viricel W, Dumontet C. · · 2023 · cited 152× · PMID 36650546 · DOI 10.1186/s13045-022-01397-y
3. Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3-Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3-Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial.
   Krop IE, Masuda N, Mukohara T, Takahashi S, et al · · 2023 · cited 102× · PMID 37801674 · DOI 10.1200/jco.23.00882
4. Resistance to antibody-drug conjugates in breast cancer: mechanisms and solutions.
   Chen YF, Xu YY, Shao ZM, Yu KD. · · 2023 · cited 93× · PMID 36357174 · DOI 10.1002/cac2.12387
5. HER3 in cancer: from the bench to the bedside.
   Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2022 · cited 71× · PMID 36271429 · DOI 10.1186/s13046-022-02515-x
6. Antibody-Drug Conjugates for the Treatment of Breast Cancer.
   Corti C, Giugliano F, Nicolò E, Ascione L, et al · · 2021 · cited 51× · PMID 34207890 · DOI 10.3390/cancers13122898
7. Antibody-Drug Conjugates in Breast Cancer: Current Status and Future Directions.
   Mark C, Lee JS, Cui X, Yuan Y. · · 2023 · cited 50× · PMID 37762027 · DOI 10.3390/ijms241813726
8. Targeting HER3 for cancer treatment: a new horizon for an old target.
   Uliano J, Corvaja C, Curigliano G, Tarantino P. · · 2023 · cited 48× · PMID 36764093 · DOI 10.1016/j.esmoop.2023.100790