AIM ImmunoTech partners with Thermo Fisher to design Phase 3 trial for Ampligen in pancreatic cancer, while Innovent Biologics begins dosing patients in Phase 3 study of IBI354 for HER2-positive breast cancer.
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
Innovent Biologics has dosed the first participant in its pivotal Phase 3 HeriCare-Breast01 study evaluating IBI354, a HER2-targeted antibody-drug conjugate, as first-line treatment for unresectable locally advanced or metastatic HER2-positive breast cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07461454 |
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07354022 |
A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. |
RECRUITING | PHASE3 |
| NCT07294430 |
Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. |
NOT_YET_RECRUITING | PHASE2 |
| NCT07235618 |
A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06788197 |
A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06764186 |
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06680921 |
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE) |
RECRUITING | PHASE3 |
| NCT06439771 |
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC |
RECRUITING | PHASE2 |
| NCT05860465 |
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer |
RECRUITING | PHASE2/PHASE3 |
| NCT05744687 |
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer |
RECRUITING | PHASE2/PHASE3 |
