 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
- LY3866288 / Eli Lilly
A first-in-human phase 1 study of LY3866288 (LOXO-435), a potent, highly isoform-selective FGFR3 inhibitor (FGFR3i) in advanced solid tumors with FGFR3 alterations: Initial results from FORAGER-1. (Level 3, Ballroom) - Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_129;
P1
LY3866288 is well-tolerated with robust clinical activity at multiple DLs, including in erdafitinib refractory mUC. Randomized dose optimization is ongoing and updated results will be presented.
- || LY3866288 / Eli Lilly
Enrollment open: A Study of [14C]-LY3866288 in Healthy Participants (clinicaltrials.gov) - Dec 4, 2024
P1, N=16, Recruiting, Sponsor: Eli Lilly and Company
Randomized dose optimization is ongoing and updated results will be presented. Not yet recruiting --> Recruiting
- || LY3866288 / Eli Lilly
Enrollment open: A Study of LY3866288 in Healthy Participants (clinicaltrials.gov) - Dec 3, 2024
P1, N=30, Recruiting, Sponsor: Eli Lilly and Company
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || LY3866288 / Eli Lilly
New P1 trial: A Study of [14C]-LY3866288 in Healthy Participants (clinicaltrials.gov) - Oct 16, 2024
P1, N=16, Not yet recruiting, Sponsor: Eli Lilly and Company
- || LY3866288 / Eli Lilly
New P1 trial: A Study of LY3866288 in Healthy Participants (clinicaltrials.gov) - Oct 15, 2024
P1, N=30, Not yet recruiting, Sponsor: Eli Lilly and Company
- || Review, Journal: FGFR-targeted therapeutics: clinical activity, mechanisms of resistance and new directions. (Pubmed Central) - Mar 25, 2024
The next generation of small-molecule inhibitors, such as lirafugratinib and LOXO-435, and the FGFR2-specific antibody bemarituzumab are expected to have a reduced risk of hyperphosphataemia and the ability to overcome certain resistance mutations. In this Review, we describe the development and current clinical role of FGFR inhibitors and provide perspective on future research directions including expansion of the therapeutic indications for use of FGFR inhibitors, combination of these agents with immune-checkpoint inhibitors and the application of novel technologies, such as artificial intelligence.
- ISM8001 / Insilico Medicine
Discovery and preclinical characterization of ISM8001, a covalent and selective FGFR2/FGFR3 dual inhibitor with strong monotherapy anti-tumor activity against advanced solid tumors (Section 13) - Mar 5, 2024 - Abstract #AACR2024AACR_8466;
Results of 28-day non-clinical toxicology studies in rat and dog showed a safety window of approximately 2-5 fold based on efficacious exposure in different models. Taken together, these data support the clinical development of ISM8001 as a novel, selective FGFR2/FGFR3 dual inhibitor for the potential tissue-agnostic therapy of advanced solid tumors with FGFR2/3 aberrations.
- LOXO-435 / Eli Lilly, Balversa (erdafitinib) / J&J, Pemazyre (pemigatinib) / Incyte, Specialised Therap
Development of a novel RNA-based fibroblast growth factor receptor response signature (FGFR-PRS) for use in patients with urothelial cancer (UC). (Level 1, West Hall; Poster Bd # D19) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_505;
P1, P2, P3
FGFR-PRS (+) tumors were associated with gene enrichments for ontologies linked to FGFR3 signaling. The correlation of FGFR-PRS score with in vitro FGFRi activity provided initial utility of the signature, which is undergoing clinical evaluation in the ALAMANCE retrospective study of UC patients treated with FGFRi or other standard-of-care therapies.
- LOXO-435 / Eli Lilly
A first-in-human phase 1 study of LOXO-435, a potent, highly isoform-selective FGFR3 inhibitor in advanced solid tumors with FGFR3 alterations (trial in progress) (Section 46; Poster Board #7) - Mar 14, 2023 - Abstract #AACR2023AACR_4817;
P1
Pts in cohort B1 must have progressed on or were intolerant to a prior FGFR inhibitor, and pts in cohorts B2, B3, and C1 must be FGFR inhibitor treatment naive. Dose expansion will evaluate the safety, PK/PD, and antitumor activity (per RECIST v1.1) of LOXO-435 at the RP2D.
- ||| LY3866288 / Eli Lilly
Enrollment open: KEYNOTE-F35: A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3 (clinicaltrials.gov) - Jan 23, 2023
P1, N=140, Recruiting, Sponsor: Eli Lilly and Company
Dose expansion will evaluate the safety, PK/PD, and antitumor activity (per RECIST v1.1) of LOXO-435 at the RP2D. Not yet recruiting --> Recruiting
- ||| LY3866288 / Eli Lilly
New P1 trial: KEYNOTE-F35: A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3 (clinicaltrials.gov) - Nov 14, 2022
P1, N=140, Not yet recruiting, Sponsor: Eli Lilly and Company