TH1902 in Patients With Advanced Solid Tumors

Summary

Open label first-in-human study of TH1902 in solid cancer, with 4 sequential parts: Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist. Part 2 (expansion): selected patient populations with recurrent advanced TNBC, HR+ breast cancer, epithelial ovarian cancer, endometrial cancer, cutaneous melanoma, thyroid cancer, SCLC, prostate cancer and other cancers known to express SORT1 that are refractory to standard therapy. Part 3 (optimization): patients diagnosed with histologically or cytologically confirmed high grade serous ovarian cancer, including high grade peritoneal or fallopian tube cancer, or high grade endometrioid cancer, that is refractory or resistant to standard therapies, should not be considered platinum sensitive, and where current therapy is not considered to be providing benefit. Part 4 (basket expansion): selected cancer type diagnosed with histologically or cytologically confirmed cancers, where TH1902 has been studied and/or showed activity (in Parts 1 to 3), that is refractory or resistant to standard therapies, and where current therapy is not considered to be providing benefit.

Timeline

Start

2021-03-04

Primary completion

2025-12

Completion

2026-01

Publications

• Background Charfi C, Demeule M, Currie JC, Larocque A, Zgheib A, Danalache BA, Ouanouki A, Beliveau R, Marsolais C, Annabi B. New Peptide-Drug Conjugates for Precise Targeting of SORT1-Mediated Vasculogenic Mimicry in the Tumor Microenvironment of TNBC-Derived MDA-MB-231 Breast and Ovarian ES-2 Clear Cell Carcinoma Cells. Front Oncol. 2021 Oct 22;11:760787. doi: 10.3389/fonc.2021.760787. eCollection 2021.
• Background Demeule M, Charfi C, Currie JC, Larocque A, Zgheib A, Kozelko S, Beliveau R, Marsolais C, Annabi B. TH1902, a new docetaxel-peptide conjugate for the treatment of sortilin-positive triple-negative breast cancer. Cancer Sci. 2021 Oct;112(10):4317-4334. doi: 10.1111/cas.15086. Epub 2021 Aug 12.

Drugs

Indications