Clinical Trials List
Protocol NumberC23-101
Active
2024-01-01 - 2028-12-31
Phase I
Not yet recruiting1
Recruiting1
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
A Phase I, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Sequential Treatment with P1101 and P1801 in Patients with Advanced Solid Tumors
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Trial Applicant
-
Sponsor
PharmaEssentia Corporation
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Trial scale
Taiwan Multiple Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Kai-Ling Lee Division of Thoracic Medicine
- 高冠鈞 Division of Hematology & Oncology
- SHAUH-DER YEH Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
TSU-YI CHAO
Co-Principal Investigator
- Wei-Hong Cheng
- Yao-Yu Hsieh Division of Hematology & Oncology
- 莊博雅
- HUI-WEN LIU
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
To evaluate the safety and tolerability of the sequential treatment with P1101 and P1801 in patients with advanced solid tumors
‧
To determine the MTD of P1801
Test Drug
injective
Active Ingredient
ropeginterferon alfa-2b
anti PD-1
anti PD-1
Dosage Form
230
230
230
Dosage
500ug/1ml
27mg/0.9ml
27mg/0.9ml
Endpoints
Incidence of DLTs, severity of adverse events (AEs) and serious adverse events (SAEs)
‧
MTD of P1801
‧
MTD of P1801
Inclution Criteria
1.
Willing to provide written informed consent;
2.
Age ≥18 years;
3.
Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have progressed despite standard therapy or are intolerant to standard therapy or for whom there is no standard therapy;
4.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at trial entry and an estimated life expectancy of at least 3 months;
5.
Dose Escalation Phase: Patients with an advanced solid tumor, including, but not limited to RCC and CRC;
Dose Expansion Phase: Patients with RCC or CRC;
6.
Prior chemotherapy and immunotherapy must have been completed at least 2 weeks and 4 weeks, respectively, before the 1st dose of P1101, and all adverse events have either returned to baseline or stabilized;
7.
Prior systemic radiation therapy must have been completed at least 4 weeks before the 1st dose of P1101;
8.
No major fundoscopic findings by ophthalmologist at screening; major fundoscopic findings including, but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes;
9.
Patient who has normal laboratory values relevant to thyroid function.
Willing to provide written informed consent;
2.
Age ≥18 years;
3.
Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have progressed despite standard therapy or are intolerant to standard therapy or for whom there is no standard therapy;
4.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at trial entry and an estimated life expectancy of at least 3 months;
5.
Dose Escalation Phase: Patients with an advanced solid tumor, including, but not limited to RCC and CRC;
Dose Expansion Phase: Patients with RCC or CRC;
6.
Prior chemotherapy and immunotherapy must have been completed at least 2 weeks and 4 weeks, respectively, before the 1st dose of P1101, and all adverse events have either returned to baseline or stabilized;
7.
Prior systemic radiation therapy must have been completed at least 4 weeks before the 1st dose of P1101;
8.
No major fundoscopic findings by ophthalmologist at screening; major fundoscopic findings including, but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes;
9.
Patient who has normal laboratory values relevant to thyroid function.
Exclusion Criteria
3.
Patients with an active autoimmune disease, a documented history of autoimmune disease or syndrome or asthma that requires systemic steroids or immunosuppressive agents;
4.
Symptomatic brain metastasis; or meningeal metastasis;
5.
Subjects with any of the following laboratory test or complications:
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Creatinine > l.5 X Upper Limit of Normal (ULN);
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Absolute neutrophil count (ANC) < 1,500/μL (transfusion or administration of any growth factors, i.e., granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, and interleukin-3, to achieve this level is not permitted within 4 weeks prior to blood draw);
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Platelet count < 100,000/μL (transfusion to achieve this level is not permitted within 2 weeks prior to blood draw);
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Hemoglobin < 9 g/dL (transfusion to achieve this level is not permitted within 8 weeks prior to blood draw);
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Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 X ULN (> 5 X ULN if liver metastasis), or total bilirubin > 1.5X ULN;
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international normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 X ULN;
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uncontrolled diabetes mellitus (HbA1c ≥7.4%);
Patients with an active autoimmune disease, a documented history of autoimmune disease or syndrome or asthma that requires systemic steroids or immunosuppressive agents;
4.
Symptomatic brain metastasis; or meningeal metastasis;
5.
Subjects with any of the following laboratory test or complications:
-
Creatinine > l.5 X Upper Limit of Normal (ULN);
-
Absolute neutrophil count (ANC) < 1,500/μL (transfusion or administration of any growth factors, i.e., granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, and interleukin-3, to achieve this level is not permitted within 4 weeks prior to blood draw);
-
Platelet count < 100,000/μL (transfusion to achieve this level is not permitted within 2 weeks prior to blood draw);
-
Hemoglobin < 9 g/dL (transfusion to achieve this level is not permitted within 8 weeks prior to blood draw);
-
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 X ULN (> 5 X ULN if liver metastasis), or total bilirubin > 1.5X ULN;
-
international normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 X ULN;
-
uncontrolled diabetes mellitus (HbA1c ≥7.4%);
The Estimated Number of Participants
-
Taiwan
54 participants
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Global
54 participants
