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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05797168 | Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors | PHASE1 | RECRUITING | 506 | — | — | Jun 5, 2023 | Jan 6, 2028 | Jun 3, 2026 | 60 | United States, Australia +10 |
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination.
A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol)
| Arm | Type | Description |
|---|---|---|
| Module 1: Torvu-sam Monotherapy | EXPERIMENTAL | Torvu-sam Monotherapy |
| Module 2: Torvu-sam + Saruparib | EXPERIMENTAL | Torvu-sam + Saruparib |
| Module 3: Torvu-sam + Bevacizumab | EXPERIMENTAL | Torvu-sam + Bevacizumab |
| Module 4: Torvu-sam + Carboplatin +/- Bevacizumab | EXPERIMENTAL | Torvu-sam + Carboplatin +/- Bevacizumab |
| Module 5: Torvu-sam + Palacaparib +/- Bevacizumab | EXPERIMENTAL | Torvu-sam + Palacaparib +/- Bevacizumab |
| Module 6: Torvu-sam + Pembrolizumab +/- Palacaparib | EXPERIMENTAL | Torvu-sam + Pembrolizumab +/- Palacaparib |
| Name | Type | Description |
|---|---|---|
| Torvutatug samrotecan | DRUG | IV Antibody-drug conjugate |
| Saruparib | DRUG | Oral PARP inhibitor |
| Bevacizumab | DRUG | IV Monoclonal antibody |
| Carboplatin | DRUG | IV Alkylating agent |
| Palacaparib | DRUG | Oral PARP inhibitor |
| Pembrolizumab | DRUG | IV Biologic |
Core Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of sample...