NCT04261218

Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Tomivosertib Combined With Paclitaxel in Advanced Breast Cancer

Completed Phase 1 Last updated 20 July 2022

What this trial tests

Phase 1 trial testing tomivosertib in Breast Cancer in 19 participants. Completed in 4 July 2022.

Timeline

25 August 2020

Primary endpoint
4 July 2022

4 July 2022

Quick facts

Lead sponsor	Translational Research in Oncology
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	25 August 2020
Primary completion	4 July 2022
Estimated completion	4 July 2022
Sites	3 locations across Canada

Drugs / interventions tested

• tomivosertib — full drug profile →
• paclitaxel — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Translational Research in Oncology — full company profile →

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 multicenter, open-label trial to evaluate the safety, pharmacodynamics (PD), pharmacokinetics (PK), and efficacy of tomivosertib in combination with paclitaxel in patients with advanced breast cancer (ABC) of any subtype.

The trial will enroll up to 45 patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 with any breast cancer (BC) subtype and at least one measurable lesion, for whom standard-of-care treatments are ineffective, not tolerated or were refused.

All patients will be initially treated with tomivosertib for 14 days (referred as the run-in period). Once treatment samples are obtained, weekly paclitaxel will be added to the treatment regimen.

Tumor assessments will be done at screening and then periodically throughout trial treatment. Patients will continue to receive trial treatment until progressive disease, as defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, intolerable trial-treatment-related toxicity, consent withdrawal, or other criteria is met (defined within the trial protocol).

Publications & conference data

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

1. A review of cancer immunotherapy: from the past, to the present, to the future.
   Esfahani K, Roudaia L, Buhlaiga N, Del Rincon SV, et al · · 2020 · cited 652× · PMID 32368178 · DOI 10.3747/co.27.5223
2. The Akt/mTOR and MNK/eIF4E pathways rewire the prostate cancer translatome to secrete HGF, SPP1 and BGN and recruit suppressive myeloid cells.
   Brina D, Ponzoni A, Troiani M, Calì B, et al · · 2023 · cited 56× · PMID 37460872 · DOI 10.1038/s43018-023-00594-z
3. Inhibiting the MNK1/2-eIF4E axis impairs melanoma phenotype switching and potentiates antitumor immune responses.
   Huang F, Gonçalves C, Bartish M, Rémy-Sarrazin J, et al · · 2021 · cited 49× · PMID 33690225 · DOI 10.1172/jci140752
4. Deeping in the Role of the MAP-Kinases Interacting Kinases (MNKs) in Cancer.
   Pinto-Díez C, Ferreras-Martín R, Carrión-Marchante R, González VM, et al · · 2020 · cited 41× · PMID 32340135 · DOI 10.3390/ijms21082967
5. "Find Me" and "Eat Me" signals: tools to drive phagocytic processes for modulating antitumor immunity.
   Xiao L, Zhang L, Guo C, Xin Q, et al · · 2024 · cited 37× · PMID 38923737 · DOI 10.1002/cac2.12579
6. Translational Regulation of Cancer Metastasis.
   Micalizzi DS, Ebright RY, Haber DA, Maheswaran S. · · 2021 · cited 35× · PMID 33479028 · DOI 10.1158/0008-5472.can-20-2720
7. mRNA translation is a therapeutic vulnerability necessary for bladder epithelial transformation.
   Jana S, Deo R, Hough RP, Liu Y, et al · · 2021 · cited 14× · PMID 34032633 · DOI 10.1172/jci.insight.144920
8. Tuning protein synthesis for cancer therapy.
   Knight JRP, Sansom OJ. · · 2021 · cited 10× · PMID 33855169 · DOI 10.1080/23723556.2021.1884034