NCT06999187 A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
| NCT ID | NCT06999187 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dren Bio |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2027-07 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic * Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available * Radiographically measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy, in the opinion of the Investigator, of ≥ 3 months * Adequate marrow reserve, renal function, and hepatic function * Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor) * Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available * Willing to undergo an on-treatment biopsy if clinically feasible and not contr
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.