A Phase 1 interventional study of LP002 and Cisplatin in Digestive System Neoplasms, sponsored by Taizhou HoudeAoke Biomedical Co., Ltd.. Status unknown at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Taizhou HoudeAoke Biomedical Co., Ltd. · Phase 1, Interventional, and Treatment
LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 94 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Taizhou HoudeAoke Biomedical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment for Arm I-A.
Malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments for Arm I-B.
Metastatic gastric carcinoma who are PD-L1 positive and systemic treatment-naive for Arm I-C.
Gastric or gastroesophageal junction carcinoma of cT2-4a, any N, M0 who are PD-L1 positive and systemic treatment-naive for Arm I-D.
Advanced solid tumors (mainly include digestive system neoplasms) who failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment or lack of standard treatments and has suitable lesions for intratumoral injection for Arm I-E.
Has sufficient organ and bone marrow function to meet the following laboratory examination standards:
Exclusion Criteria:
Has received systemic corticosteroids or other immunosuppressive drugs within 2 weeks before the first administration of the study drug, excluding:
LP002 dose escalation (3+3 design): 6-12 patients with malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment will receive LP002 600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W), for up to 2 year.
Drug: LP002
If the safety profile in Arm A is acceptable, 9-12 patients with malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments will receive LP002 600mg or 900 mg IV on Day 1, Q2W, for up to 2 year.
Drug: LP002
If the safety profile in Arm A is acceptable, 15-20 patients with metastatic gastric carcinoma who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W,for up to 2 year.
Drug: LP002 · Drug: Cisplatin · Drug: Fluorouracil
Perioperative treatment: If the safety profile in Arm A is acceptable, 15-20 patients with gastric or gastroesophageal junction carcinoma of cT2-4a, any N, M0 who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W, for 3 cycles, 4-6 weeks before operation of the tumor and receive additional 6 cycles of the same therapy 4 weeks after the operation.
Drug: LP002 · Drug: Cisplatin · Drug: Fluorouracil
Dose escalation (3+3 design) of OH2 (an oncolytic virus) + LP002 900mg：If the safety profile in Arm A is acceptable, 15-30 patients with advanced solid tumors (mainly include digestive system neoplasms) who failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment or lack of standard treatments will receive LP002 900mg IV on Day 1, Q2W, and OH2 10\^6 or 10\^7 or 10\^8 CCID50/mL by intra-tumoral injection, Q2W, for up to 2 year.
Drug: LP002 · Biological: OH2 oncolytic virus
600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).
50mg/m2 IV on Day 1, Q2W
2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W
106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to approximately 24 months
Objective Response Rate (ORR) for Arm I-A, I-B, I-C, I-E
Percentage of subjects achieving complete response (CR) and partial response (PR). R0 resection rate RFS pCR
Time frame: up to approximately 24 months
Disease Control Rate (DCR) for Arm I-A, I-B, I-C, I-E
Disease Control Rate (DCR) refers to the proportion of subjects who achieve CR, PR and SD through imaging evaluation.
Time frame: up to approximately 24 months
Duration of Response (DOR) for Arm I-A, I-B, I-C, I-E
Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.
Time frame: up to approximately 24 months
Progression-Free Survival (PFS) for Arm I-A, I-B, I-C, I-E
Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.
Time frame: up to approximately 24 months
Overall survival (OS) for Arm I-A, I-B, I-C, I-D, I-E
Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.
Time frame: up to approximately 24 months
R0 resection rate for Arm I-D
R0 resection rate refers to the rate of patients who have achieved curative resection of the tumor.(Curative resection refers to the absence of tumor after surgical treatment. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.)
Time frame: up to approximately 12 months
pathological complete response rate (pCR rate)
pathological complete response rate (pCR rate) refers to the rate of patients whose tissue samples show no cancer cells left under a microscope after the anti-cancer treatment.
Time frame: up to approximately 12 months
Terminal half life of LP002
Time frame: up to approximately 12 months
Area under curve of LP002
Time frame: up to approximately 12 months
Apparent volume of distribution of LP002
Time frame: up to approximately 12 months
Systemic clearance of LP002
Time frame: up to approximately 12 months
Cmax of LP002
Time frame: up to approximately 12 months
Tmax of LP002
Time frame: up to approximately 12 months
Serum concentration of the antibody against LP002 within 1 hour prior to each administration
Time frame: up to approximately 24 months
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Taizhou HoudeAoke Biomedical Co., Ltd.