Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LOXO-292 · 1 trial · 4 indications
The MTD is defined as the highest dose level at which none of the first 3 treated patients, or not more than 1 of the first 6 treated patients, experiences a DLT. A DLT is any adverse events that starts on or after first administration of study drug, as defined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. * Any Grade(G) ≥3 nonhematologic toxicity, excluding * G3 AST, ALT, and/or total bilirubin elevation for \<7 days. * G3 neutropenia \<7 days * G3 thrombocytopenia without clinically significant bleeding * G3 or G4 lymphopenia. * First occurrence of G3 or G4 electrolyte abnormalities * G3 fatigue, weakness, nausea; other manageable constitutional symptom * G3 or G4 vomiting or diarrhea that lasts for \<48hours with antiemetic/antidiarrheal medication in case of G3 and \<24 hours in case of G4 * G4 manageable constitutional symptom.
Phase 1: RP2D
Objective Response Rate was defined as the percentage of participants with best overall response of confirmed response (CR), or Partial response (PR). Response was confirmed by a repeat assessment no less than 28 days. * CR is defined as disappearance of all target lesions. * PR is defined as at least a 30% decrease in the sum of diameter (LD for non-nodal lesions and short axis diameter \[SAD\] for nodal lesions) of target lesions, taking as reference the baseline sum LD. ORR was assessed by independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 95% confidence interval was calculated using Clopper-Pearson method.
| Arm | Type | Description |
|---|---|---|
| Phase 1: 20 mg Selpercatinib QD | EXPERIMENTAL | Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 20 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 40 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 60 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 160 mg Selpercatinib QD | EXPERIMENTAL | Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 80 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 120 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 160 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 200 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 1: 240 mg Selpercatinib BID | EXPERIMENTAL | Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 2, Cohort 1: RET Fusion Solid Tumor | EXPERIMENTAL | Participants with Rearranged during transfection (RET) Fusion solid tumor progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy | EXPERIMENTAL | Participants with RET Fusion solid tumor without standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 2, Cohort 3: RET Mutant MTC | EXPERIMENTAL | Participants with RET mutant medullary thyroid cancer (MTC) progressed on/intolerant to standard first line therapy received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy | EXPERIMENTAL | Participants with RET mutant MTC without prior standard first line therapy or other kinase inhibitor(s) with anti-RET activity received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 2, Cohort 5: Advanced RET Altered Solid Tumor | EXPERIMENTAL | Participants with RET altered solid tumor (cohorts 1-4, disease not measurable; MTC not eligible for Cohort 3 or 4; MTC syndrome spectrum cancer; circulating free tumor DNA \[cfDNA+\] for RET alteration not known to be present in tumor) received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants | EXPERIMENTAL | Participants otherwise eligible for Cohorts 1-5 who discontinued other RET inhibitors received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a continuous 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons. |
| Name | Type | Description |
|---|---|---|
| LOXO-292 | DRUG | Oral LOXO-292 |
Key Inclusion Criteria: For Phase 1: * Participants with a locally advanced or metastatic solid tumor that: * Has progressed on or is intolerant to standard therapy, or * For which no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tol...
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LOXO-292 is an investigational small molecule being developed for the treatment of non-small cell lung cancer. It is also being studied in other RET fusion-positive solid tumors and medullary thyroid cancer. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
LOXO-292 targets the RET kinase, a molecular target involved in tumor growth. As a kinase inhibitor, it is designed to block the activity of RET, which can drive cancer cell proliferation. This mechanism is being evaluated in clinical trials for non-small cell lung cancer and other RET fusion-positive tumors.
LOXO-292 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for non-small cell lung cancer and other solid tumors.
LOXO-292 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively enrolling participants to evaluate the drug's safety and efficacy in advanced solid tumors.
LOXO-292 is being studied in a Phase 1 clinical trial with the identifier NCT03157128, known as the LIBRETTO-001 study. This trial is evaluating the drug in participants with advanced solid tumors, RET fusion-positive solid tumors, and medullary thyroid cancer. The trial is active but not recruiting participants.
Yes, LOXO-292 is also known as selpercatinib. The drug is being developed by Eli Lilly and Company for the treatment of non-small cell lung cancer and other RET fusion-positive solid tumors. It is currently in Phase 1 clinical development under the trial name LIBRETTO-001.