Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB0123667 · 1 trial · 1 indication
Toxicities occurring during the first treatment cycle, Part 1a, will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Participants will receive dose reductions of INCB123667 according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.
Participants will receive dose reductions according to lab guidelines. Treatment may be delayed for up to 2 weeks to allow for resolution of toxicity.
TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Arm | Type | Description |
|---|---|---|
| Phase 1a Dose Escalation | EXPERIMENTAL | INCB123667 will be administered at a protocol defined starting regimen once daily (QD) orally in 28-day cycles. Subsequent dose regimens will be determined during study conduct. |
| Phase 1b: Dose Expansion Cohort Disease Group 1 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) will enroll in this group. |
| Phase 1b: Dose Expansion Cohort Disease Group 2 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Endometrial/Uterine cancer will enroll in this group. |
| Phase 1b: Dose Expansion Cohort Disease Group 3 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with gastric, Gastro Esophageal Junction (GEJ), and esophageal adenocarcinomas will enroll in this group. |
| Phase 1b: Dose Expansion Cohort Disease Group 4 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with Triple Negative Breast Cancer(TNBC) will enroll in this group. |
| Phase 1b: Dose Expansion Cohort Disease Group 5 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors. Participants with HR+/HER2- breast cancer who have had disease progression on or been intolerant of a CDK4/6 inhibitor will enroll in this group. |
| Phase 1b: Dose Expansion Cohort Disease Group 6 | EXPERIMENTAL | INCB123667 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for advanced or metastatic solid tumors will enroll in this group. |
| Phase 2a Dose Escalation Treatment Group A (TGA) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group B (TGB) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group C (TGC) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group D (TGD) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group E (TGE) | EXPERIMENTAL | INCB123667 administered in combination with bevacizumab at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group F (TGF) | EXPERIMENTAL | INCB123667 administered in combination with olaparib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2a Dose Escalation Treatment Group G (TGG) | EXPERIMENTAL | INCB123667 administered in combination with paclitaxel at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group H (TGH) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group I (TGI) | EXPERIMENTAL | INCB123667 administered in combination with palbociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol |
| Phase 2b Dose Expansion Treatment Group J (TGJ) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib at the recommended doses in participants with HR+/HER2- breast cancer and in participants with a different tumor as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group K (TGK) | EXPERIMENTAL | INCB123667 administered in combination with ribociclib and fulvestrant at the recommended doses in participants with HR+/HER2- breast cancer as defined in the protocol. |
| Phase 2b Dose Expansion Treatment Group L (TGL) | EXPERIMENTAL | INCB123667 administered in combination with bevacizumab at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol. |
| Phase 2b Dose Expansion Treatment Group M (TGM) | EXPERIMENTAL | INCB123667 administered in combination with olaparib at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol. |
| Phase 2b Dose Expansion Treatment Group N (TGN) | EXPERIMENTAL | INCB123667 administered in combination with weekly paclitaxel at the recommended doses in participants with gynecologic tumors (epithelial ovarian/fallopian/primary peritoneal carcinoma) as defined by the protocol. |
| Name | Type | Description |
|---|---|---|
| INCB0123667 | DRUG | 25 mg tablets |
| Palbociclib | DRUG | Palbociclib will be administered at protocol defined dose. |
| Bevacizumab | DRUG | Bevacizumab will be administered at protocol defined dose. |
| Olaparib | DRUG | Olaparib will be administered at protocol defined dose. |
| Paclitaxel | DRUG | Paclitaxel will be administered at protocol defined dose. |
| Ribociclib | DRUG | Ribociclib will be administered at protocol defined dose. |
| Fulvestrant | DRUG | Fulvestrant will be administered at protocol defined dose. |
Inclusion Criteria: * Adults aged 18 years or older at the time of the signing of the ICF. * Life expectancy greater than 12 weeks. * ECOG performance status score of 0 or 1. * Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available t...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
INCB0123667 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial enrolling patients with solid tumors across multiple countries.
INCB0123667 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors.
INCB0123667 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to evaluate the drug in advanced solid tumors.
INCB0123667 is being studied in a single Phase 1 clinical trial with the identifier NCT05238922, titled 'Study of INCB123667 in Subjects With Advanced Solid Tumors.' The trial is active but not recruiting and has a target enrollment of 291 participants across the United States, France, Italy, Japan, Netherlands, Puerto Rico, Switzerland, and the United Kingdom.
Yes, INCB0123667 is the same drug as INCB123667. The clinical trial NCT05238922 uses the name INCB123667 in its title, while the drug is also referred to as INCB0123667. Both names refer to the same investigational small molecule being developed by Incyte Corporation for advanced solid tumors.