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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05029999 | CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer | PHASE1 | RECRUITING | 30 | — | — | Apr 20, 2022 | Apr 20, 2026 | Aug 13, 2025 | 7 | United States |
DLTs are defined as toxicities that meet pre-defined severity criteria including serious Hematologic/Non-Hematologic adverse events (AEs) and AEs at Grade 3 or above; Any ≥ grade 2 eye pain or reduction of visual acuity that does not improved to ≤ grade 1 severity within 2 weeks of initiation of topical therapy or requires systemic treatment. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle until toxicity or progression. CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle until toxicity or progression for up to 24 months. CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 1 and 2 only. |
| Cohort C | EXPERIMENTAL | PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle until toxicity or progression. CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle starting on cycle 2 until toxicity or progression for up to 24 months. CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 days cycles 2 and 3 only. |
| Name | Type | Description |
|---|---|---|
| PLD Chemotherapy | DRUG | PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle. |
| CDX-1140 | DRUG | CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle. |
| CDX-301 | DRUG | CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 doses per cycle for 2 cycles. |
Inclusion Criteria: * Unresectable Stage III or Stage IV HER2 negative breast cancer (either triple negative or hormone receptor positive) * Triple negative breast cancer for this study is defined as estrogen receptor \<10%, progesterone receptor \<10% by immunohistochemistry, and HER2- negative...