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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05107674 | A Study of NX-1607 in Adults With Advanced Malignancies | PHASE1 | RECRUITING | 345 | — | — | Sep 29, 2021 | Feb 28, 2028 | Sep 9, 2025 | 17 | United States, United Kingdom |
Phase 1a
Phase 1a
Phase 1b
| Arm | Type | Description |
|---|---|---|
| Phase 1a Dose Escalation of NX-1607 (monotherapy) | EXPERIMENTAL | Multiple dose levels and dosing regimen of NX-1607 to be evaluated; determination of MTD/Phase 1b recommended dose. |
| Phase 1a Food Effect | EXPERIMENTAL | Impact of food on NX-1607 bioavailability and tolerability to be evaluated |
| Phase 1b Dose Expansion in platinum-resistant EOC | EXPERIMENTAL | Patients with platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma |
| Phase 1b Dose Expansion in advanced gastric/GEJ cancer | EXPERIMENTAL | Patients with recurrent, locally advanced, or metastatic gastric or GEJ adenocarcinoma |
| Phase 1b Dose Expansion in HNSCC | EXPERIMENTAL | Patients with recurrent, locally advanced, or metastatic HNSCC |
| Phase 1b Dose Expansion in recurrent melanoma | EXPERIMENTAL | Patients with recurrent and either metastatic or unresectable Melanoma |
| Phase 1b Dose Expansion in advanced NSCLC | EXPERIMENTAL | Patients with Stage IV NSCLC |
| Phase 1b Dose Expansion in mCRPC | EXPERIMENTAL | Patients with mCRPC who received a minimum of 2 prior lines of therapy in the advanced setting including androgen receptor-directed therapy and a taxane-based chemotherapy and has PSA or radiographic progression |
| Phase 1b Dose Expansion in mixed solid tumor cohort | EXPERIMENTAL | Cohort of mixed solid tumor indications consisting of patients with MPM, TNBC, locally advanced or metastatic urothelial cancer, cervical cancer, or DLBCL/DLBCL-RT |
| Phase 1a Dose Escalation of NX-1607 in combination with Paclitaxel | EXPERIMENTAL | Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer. HSNCC, NSCLC, TNBC, locally advanced or metastatic urothelial cancer and cervical cancer. |
| Phase 1b Dose Expansion of NX-1607 in combination with Paclitaxel | EXPERIMENTAL | Indications may include but are not limited to, platinum resistant EOC, gastric/GEJ cancer, HSNCC, NSCLC, TNBC, and locally advanced or metastatic urothelial cancer and cervical cancer |
| Phase 1b Dose Expansion in MSS CRC | EXPERIMENTAL | Patients with histologically confirmed MSS CRC, known KRAS WT, and must have been previously treated with \> = 2 lines of systemic therapy including a fluoropyrimidine, irinotecan, and/or oxaliplatin (and EGFR inhibitor if known Ras wild type) |
| Name | Type | Description |
|---|---|---|
| NX-1607 | DRUG | Oral NX-1607 |
| Paclitaxel | DRUG | Paclitaxel IV |
Key Inclusion Criteria: * Age ≥ 18 years. * Measurable disease per disease-specific response criteria. * Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from...