Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05238922 | Study of INCB123667 in Subjects With Advanced Solid Tumors | PHASE1 | RECRUITING | 604 | — | — | Jul 5, 2022 | Aug 31, 2027 | Apr 14, 2026 | 42 | United States, France +6 |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |