Clinical Research Directory

Neoantigen Peptide Vaccine Plus Pembrolizumab in Renal Cell Carcinoma

This is a Phase I, single-center, open-label, single-arm clinical trial to evaluate the safety and efficacy of personalized neoantigen polyepitope peptide vaccine combined with pembrolizumab in patients with advanced, recurrent or refractory renal cell carcinoma (RCC). Background: Renal cell carcinoma is one of the most common malignancies of the urinary system. Although pembrolizumab has become a standard first-line treatment, the objective response rate (ORR) of monotherapy is only 20-40%, and most patients eventually develop primary or acquired resistance. Tumor neoantigens are specific antigens produced by tumor-specific gene mutations, with high immunogenicity and tumor specificity, making them ideal targets for tumor immunotherapy. Preliminary clinical studies have shown that neoantigen vaccines can produce synergistic effects when combined with pembrolizumab. Study Design: This is an investigator-initiated trial (IIT) conducted at Peking University First Hospital. The study will enroll 5-8 patients in two stages: an initial safety assessment cohort (3 patients) followed by an expansion cohort (5 additional patients) if safety criteria are met. The study drug is a personalized neoantigen polyepitope peptide vaccine (Neo-RCC), produced by Mingzhibenyuan Medical Technology (Beijing) Co., Ltd., based on whole exome sequencing (WES) and transcriptome sequencing (RNA-seq) of each patient's tumor tissue. The vaccine is administered via subcutaneous injection in combination with Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (Poly-ICLC) adjuvant, with a priming phase (5 injections on Days 0, 3, 7, 14, 21) and a boosting phase (3 injections on Weeks 6, 12, and 20), totaling 8 injections. Pembrolizumab (200 mg intravenous \[IV\] every 3 weeks \[Q3W\]) is administered concurrently as combination therapy. Primary Objective: To evaluate the safety of the personalized neoantigen peptide vaccine in advanced RCC patients, as measured by the incidence and severity of treatment-emergent adverse events (TEAE) graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Secondary Objectives: To evaluate pharmacokinetic characteristics; to assess efficacy including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key Eligibility Criteria: Adults (≥18 years) with Stage III or IV, locally advanced, recurrent or metastatic non-surgical RCC who have achieved disease stability for ≥3 months after prior targeted therapy combined with pembrolizumab; measurable disease per RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status 0-3; adequate organ function; and ≥50 tumor gene mutations detectable from biopsy tissue. Safety Monitoring: A Data Safety Monitoring Board (DSMB) will oversee patient safety. Dose-limiting toxicities (DLT) are defined according to protocol-specified criteria. If ≥2 DLTs occur in the initial cohort, the adjuvant dose will be reduced by 50% and the study will proceed with a de-escalation cohort.

Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

NB003-04 is a phase II/III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of NB003 in patients with gastrointestinal stromal tumors aged 18 years and above (or the legal adult age of consent per local regulations, whichever is older). Participants who are eligible for this study are those who have experienced disease progression or documented intolerance following treatment with either imatinib and sunitinib or following treatment with imatinib. This study consists of two parts. Part 1 (hereinafter referred to as Part 1) compares the efficacy of NB003 versus regorafenib in patients who need a third-line therapy for GIST who have failed sequential therapy with imatinib and sunitinib. Part 2 (hereinafter referred to as Part 2) evaluates the efficacy of NB003 in patients who need a second-line therapy for GIST who have failed treatment with imatinib.

IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer

This study is for patients with advanced or metastatic gastric cancer whose disease has worsened after first-line systemic therapy. IBI363 is an investigational antibody that may help the immune system recognize and attack cancer cells. This trial will evaluate IBI363 in combination with bevacizumab, with or without nab-paclitaxel, as a second-line treatment. The study has two parts. In the phase Ib part, small groups of patients will receive IBI363 plus bevacizumab with or without nab-paclitaxel to evaluate the safety, side effects, and tolerability of the combination and to determine an appropriate dose for further study. In the phase II part, additional patients will receive the selected regimen to assess the preliminary antitumor activity of IBI363 in combination with bevacizumab ± nab-paclitaxel, including tumor response and other clinical outcomes, as well as to further describe the safety profile. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons defined in the protocol.