Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SX-682 · 1 trial · 1 indication
The biological active and tolerable combination doses are those that satisfy observed DLT rate\<33% and demonstrate reduction in myeloid derived suppressor cells (MDSCs).
Response rate on the basis of Prostate Cancer Working Group 3 (PCWG3), and/or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| Phase I: Dose Escalation | EXPERIMENTAL | Phase I will identify a biologically active and tolerable (safe) dose range of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC). |
| Phase II: Dose Expansion | EXPERIMENTAL | Phase I will investigate the anti-tumour activity of tolerable doses of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC). Patients will be treated at dose levels deemed to be tolerable and biologically active, based on safety and efficacy data from Dose Escalation. |
| Name | Type | Description |
|---|---|---|
| SX-682 | DRUG | SX-682 is supplied as 100mg film coated tablets. |
| Apalutamide | DRUG | Apalutamide is supplied as 60mg film coated tablets. |
Inclusion Criteria: 1. Written informed consent and be capable of cooperating with treatment. 2. Age ≥ 18 years. 3. Histologically or biochemically confirmed adenocarcinoma of the prostate and with tumour tissue accessible for research analysis for this trial. Patients who have no histological diag...