Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in P
This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant therap
| Condition(s) | Esophageal Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant therapy cohort(IPM514 combined with anti-PD-1 antibody, cisplatin and paclitaxel).The dose escalation and dose expansion stages will include patients with unresectable advanced, recurrent or metastatic ESCC who have failed first-line treatment. After confirming the preliminary safety and effectiveness in the dose escalation and dose expansion stages, a neoadjuvant therapy cohort study will be developed, and resectable ESCC subjects will be included. |
| Who can participate | Inclusion Criteria: 1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments. 2. Male or female, aged ≥ 18 years. 3. Histologically confirmed diagnosis of esophageal squamous cell carcinoma. 4. Dose escalation and dose expansion stages: After at least one line of systemic treatment (PD-1 antibody combined with platinum-based chemotherapy) has progressed or is intolerable. The following situations are regarded as the failure of the first-line standard treatment: * Tumor recurrence/progression during neoadjuvant/adjuvant immunotherapy combined with platinum-containing chemotherapy. * Patients with disease recurrence within 6 months after completing neoadjuvant/adjuvant treatment, and this neoadjuvant |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Peking University |
| Locations | Beijing, China |
| Start date | 2024-10-10 |
| NCT ID | NCT06690476 |
| Official listing | https://clinicaltrials.gov/study/NCT06690476 |