The FDA said one pivotal trial plus confirmatory evidence will become the default standard for approval of most new drugs. The shift could extend beyond rare diseases to common conditions affecting millions.
Early trial of Rezatapopt shows 20% response rate in advanced cancers with p53 mutations, while researchers identify AMD3100 as potential solution to enable immunotherapy in rare liver cancer.
Grail's multi-cancer blood test failed to significantly boost early detection or reduce late-stage diagnoses in a 142,000-person UK trial, raising doubts about regulatory approval and commercial prospects.
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07260708 |
Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers |
RECRUITING | PHASE1 |
| NCT06649656 |
A Multicenter, Open Label Phase I Clinical Trial Evaluating the Safety and Pharmacokinetics of TQB2252 Injection in Subjects With Advanced Malignant Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT06413953 |
A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors |
RECRUITING | PHASE1 |
| NCT06001749 |
Psilocybin in Cancer Pain Study |
RECRUITING | PHASE2 |
| NCT05380882 |
Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers |
UNKNOWN | PHASE1 |
| NCT05333276 |
Clinical Trial of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers |
UNKNOWN | PHASE1 |
| NCT03726333 |
Hepatic Impairment Study for Lorlatinib in Cancer Patients |
TERMINATED | PHASE1 |
| NCT03375983 |
Plasmodium Immunotherapy for Advanced Cancers |
RECRUITING | PHASE1/PHASE2 |
| NCT02873975 |
A Study of LY2606368 (Prexasertib) in Patients With Solid Tumors With Replicative Stress or Homologous Repair Deficiency |
COMPLETED | PHASE2 |
| NCT02801045 |
Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient |
COMPLETED | NA |
