Solid Tumors, Colorectal Cancer and Breast Cancer
Conditions
Brief summary
Phase 1a: ELVN-002 + Trastuzumab: • Incidence of dose limiting toxicities (DLTs), Phase 1a: ELVN-002 + Trastuzumab: • Incidence of adverse events (AEs), laboratory abnormalities, and electrocardiogram (ECG) abnormalities, Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: • Incidence of dose limiting toxicities (DLTs), Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: • Incidence of dose limiting toxicities (DLTs), Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: • Incidence of adverse events (Aes), laboratory abnormalities, and electrocardiogram (ECG) abnormalities
Detailed description
Phase 1a: ELVN-002 plasma concentrations and PK parameters, including: area under the curve (AUC), maximum concentration (Cmax), timeat which Cmax is observed (Tmax), minimum concentration (Cmin), terminal half-life (T1/2), and other parameters such as dose proportionality and accumulation ratio, Phase 1a: Confirmed ORR as assessed by investigators per RECIST v1.1, Phase 1b: Confirmed ORR and DOR as assessed by ICR per RECIST v1.1, Phase 1b: Brain metastases response, Phase 1b: ELVN-002 plasma concentrations
Interventions
DRUGInjektionslösung
DRUGELVN-002
DRUGHerceptin 150 mg powder for concentrate for solution for infusion
Sponsors
Enliven Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1a: ELVN-002 + Trastuzumab: • Incidence of dose limiting toxicities (DLTs), Phase 1a: ELVN-002 + Trastuzumab: • Incidence of adverse events (AEs), laboratory abnormalities, and electrocardiogram (ECG) abnormalities, Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: • Incidence of dose limiting toxicities (DLTs), Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: • Incidence of dose limiting toxicities (DLTs), Phase 1a: ELVN-002 + Trastuzumab + Chemotherapy: • Incidence of adverse events (Aes), laboratory abnormalities, and electrocardiogram (ECG) abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1a: ELVN-002 plasma concentrations and PK parameters, including: area under the curve (AUC), maximum concentration (Cmax), timeat which Cmax is observed (Tmax), minimum concentration (Cmin), terminal half-life (T1/2), and other parameters such as dose proportionality and accumulation ratio, Phase 1a: Confirmed ORR as assessed by investigators per RECIST v1.1, Phase 1b: Confirmed ORR and DOR as assessed by ICR per RECIST v1.1, Phase 1b: Brain metastases response, Phase 1b: ELVN-002 plasma concentrations | — |
Countries
Belgium, France, Italy, Netherlands, Spain
Outcome results
None listed