Clinical Trials List
Protocol NumberRP-72-002
NCT Number(ClinicalTrials.gov Identfier)NCT04338763
Active
2020-11-13 - 2026-12-31
Phase I
Recruiting2
ICD-10C25.0
Malignant neoplasm of head of pancreas
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9157.0
Malignant neoplasm of head of pancreas
A Phase I Study to Evaluate the Safety and Efficacy of RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
-
Trial Applicant
T-TOP Clinical Research Co., Ltd.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Shang-Wen Chen Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yan-Shen Shan
Co-Principal Investigator
- Chia-Jui Yen Division of Hematology & Oncology
- 姜乃榕 Division of Hematology & Oncology
- 蘇勇曄 Division of Hematology & Oncology
- Chien-Jui Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Pancreatic Cancer
Objectives
Primary Objectives:
# To determine the maximum tolerated dose (MTD) and recommended dose for Phase II trials of RP72 in pancreatic cancer patients after monotherapy and combination therapy with gemcitabine.
Secondary Objectives:
# To determine overall safety and toxicity data for RP72 in pancreatic cancer patients after monotherapy and combination therapy with gemcitabine.
# To assess the antitumor activity of RP72 in pancreatic cancer patients after monotherapy and combination therapy with gemcitabine, according to RECIST v1.1.
# To assess changes in quality of life (QoL) using the European Association for Research and Treatment of Cancer (EORTC) QLQ-C30.
# To understand the pharmacokinetics (PK) of the investigational drug RP72 in pancreatic cancer patients in different study groups.
Test Drug
凍晶注射劑
Active Ingredient
RP72重組蛋白
Dosage Form
243
Dosage
瓶
Endpoints
1. Primary Assessment Result
- Determine the maximum tolerated dose (MTD) and recommended dose for Phase II trials after RP72 monotherapy and combination therapy with gemcitabine.
- Determine the maximum tolerated dose (MTD) and recommended dose for Phase II trials after RP72 monotherapy and combination therapy with gemcitabine.
Inclution Criteria
Inclusion Criteria:
Age ≥ 18 years (in certain territories, the minimum age requirement may be higher, e.g. age ≥ 20 years in Taiwan)
Written informed consent
Patient must meet one of the following criteria based on:
Arm A (RP72 monotherapy): Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic cancer that has progressed on (or intolerant of) one or more standard treatment regimen(s) or for which no effective therapy is available. Note: Prior exposure to gemcitabine as a single agent or in combination with other agents (as part of multi-agent chemotherapy regimen) is acceptable.
Or
Arm B (RP72 in combination with Gemcitabine): Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic cancer that has progressed on (or intolerant of) one or more standard treatment regimen(s) and is expected (or currently receiving) standard treatment with gemcitabine.Note: Patients who have already started on gemcitabine need to have no evidence of disease progression at the time of screening in order to be eligible for the study.
Note: The definition of unresectability will follow the criteria of NCCN guidelines (Carroll et al. version 2.2016, PANC-B)
Fasting blood glucose <160 mg/dl, prior to study enrollment. (For higher values, blood glucose may be controlled by dietary intervention, oral hypoglycemics and/ or insulin prior to enrollment)
Estimated life expectancy of ≥12 weeks
Adequate hematologic and end-organ function
Measurable / assessable disease according to RECIST v.1.1
ECOG performance status 0 or 1
Subjects who are eligible and able to participate in the study and accept to enter the study by signing written informed consent forms
Patients are recovered from toxicities from prior systemic therapies and have adequate hematopoietic, liver and renal function at screening and before using study medication
Haemoglobin ≥ 8 g/dL
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Absolute lymphocyte count ≥ 1000/mm3,
Platelets ≥ 80,000 /mm3
Total white blood cell (WBC) ≥ 3,000 cells /mm3
Coagulation tests (prothrombin time [PT], activated partial thromboplastin time [aPTT], International Normalized Ratio [INR]) < 1.5×ULN,
Total bilirubin ≤ 1.5×ULN,
Aspartate Aminotransferase (AST)/Serum Glutamic Oxaloacetic Transaminase(SGOT) and/or Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic Transaminase (SGPT) ≤ 3 x ULN (or ≤ 5×ULN if liver metastases are present
Albumin > 2.5 g/dL
Creatinine Clearance (CrCl) > 50 mL/min[Cockcroft-Gault equation]
All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after RP72 treatment shown below.
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
Combination of any two of the following (a+b or a+c, or b+c):
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Age ≥ 18 years (in certain territories, the minimum age requirement may be higher, e.g. age ≥ 20 years in Taiwan)
Written informed consent
Patient must meet one of the following criteria based on:
Arm A (RP72 monotherapy): Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic cancer that has progressed on (or intolerant of) one or more standard treatment regimen(s) or for which no effective therapy is available. Note: Prior exposure to gemcitabine as a single agent or in combination with other agents (as part of multi-agent chemotherapy regimen) is acceptable.
Or
Arm B (RP72 in combination with Gemcitabine): Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic cancer that has progressed on (or intolerant of) one or more standard treatment regimen(s) and is expected (or currently receiving) standard treatment with gemcitabine.Note: Patients who have already started on gemcitabine need to have no evidence of disease progression at the time of screening in order to be eligible for the study.
Note: The definition of unresectability will follow the criteria of NCCN guidelines (Carroll et al. version 2.2016, PANC-B)
Fasting blood glucose <160 mg/dl, prior to study enrollment. (For higher values, blood glucose may be controlled by dietary intervention, oral hypoglycemics and/ or insulin prior to enrollment)
Estimated life expectancy of ≥12 weeks
Adequate hematologic and end-organ function
Measurable / assessable disease according to RECIST v.1.1
ECOG performance status 0 or 1
Subjects who are eligible and able to participate in the study and accept to enter the study by signing written informed consent forms
Patients are recovered from toxicities from prior systemic therapies and have adequate hematopoietic, liver and renal function at screening and before using study medication
Haemoglobin ≥ 8 g/dL
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Absolute lymphocyte count ≥ 1000/mm3,
Platelets ≥ 80,000 /mm3
Total white blood cell (WBC) ≥ 3,000 cells /mm3
Coagulation tests (prothrombin time [PT], activated partial thromboplastin time [aPTT], International Normalized Ratio [INR]) < 1.5×ULN,
Total bilirubin ≤ 1.5×ULN,
Aspartate Aminotransferase (AST)/Serum Glutamic Oxaloacetic Transaminase(SGOT) and/or Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic Transaminase (SGPT) ≤ 3 x ULN (or ≤ 5×ULN if liver metastases are present
Albumin > 2.5 g/dL
Creatinine Clearance (CrCl) > 50 mL/min[Cockcroft-Gault equation]
All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use appropriate contraception method(s) for at least 4 weeks after RP72 treatment shown below.
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
Combination of any two of the following (a+b or a+c, or b+c):
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Exclusion Criteria
Exclusion Criteria:
Patients with endocrine or acinar pancreatic carcinoma.
Patients who present with jaundice; Note: Patients who present with jaundice will be allowed to enroll after control with temporary or permanent internal/external drainage.
Any severe infection, uncontrolled systemic disease (e.g., cardiopulmonary insufficiency, fatal arrhythmias, hepatitis, etc) that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
Major surgery within 4 weeks from the first dose of the study drug
Female subjects that are lactating, pregnant, or planned to become pregnant
Investigational medicinal product within 4 weeks or less than 5 half-life periods (whichever is shorter) from the first dose of the study drug
Concurrent use of immunosuppressive medication. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions
Active autoimmune diseases requiring treatment or a history of autoimmune disease.
Documented HIV history
Active hepatitis B infection requiring acute therapy.
Positive results of hepatitis B surface (HBs) antigen,
Positive results of hepatitis B e antigen (HBeAg), and
HBV-DNA >2000 IU/mL Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria.
Note: Subjects with HBsAg(+) and HBeAg(-) will be eligible for the study if his/her HBV-DNA titer is lower than 2000 IU/mL.
Chronic active hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening. Note:Subjects infected by the hepatitis C virus will be eligible for the study if the titer of HCV-RNA is below the limit of quantification after HCV treatment.
History of malignancy other than pancreatic cancer < 3 years prior to enrolment, except non-melanoma skin cancer or carcinoma in situ of the cervix treated locally or carcinoma in situ considered cured by local treatment
Known hypersensitivity to any component of the RP72 and/or Gemcitabine formulations (including kanamycin or other aminoglycosides)
Subjects that received radiation to ≥ 25% of their bone marrow within 4 weeks of the first dose of study drug.
Evidence of central nervous system (CNS) metastasis. Note: Subjects who have a central nervous system metastasis that has been treated, stable and has not needed treatment for at least 4 weeks at the time of screening will be allowed to enroll in the study.
Subjects that have on-going moderate to severe organ impairment, other than the study indication, that may confound the efficacy evaluation, safety evaluation or usage of standard chemotherapy
Corrected QT interval (QTc) ≥ 470 msec on the 12-lead ECG
Patients with endocrine or acinar pancreatic carcinoma.
Patients who present with jaundice; Note: Patients who present with jaundice will be allowed to enroll after control with temporary or permanent internal/external drainage.
Any severe infection, uncontrolled systemic disease (e.g., cardiopulmonary insufficiency, fatal arrhythmias, hepatitis, etc) that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
Major surgery within 4 weeks from the first dose of the study drug
Female subjects that are lactating, pregnant, or planned to become pregnant
Investigational medicinal product within 4 weeks or less than 5 half-life periods (whichever is shorter) from the first dose of the study drug
Concurrent use of immunosuppressive medication. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions
Active autoimmune diseases requiring treatment or a history of autoimmune disease.
Documented HIV history
Active hepatitis B infection requiring acute therapy.
Positive results of hepatitis B surface (HBs) antigen,
Positive results of hepatitis B e antigen (HBeAg), and
HBV-DNA >2000 IU/mL Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria.
Note: Subjects with HBsAg(+) and HBeAg(-) will be eligible for the study if his/her HBV-DNA titer is lower than 2000 IU/mL.
Chronic active hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening. Note:Subjects infected by the hepatitis C virus will be eligible for the study if the titer of HCV-RNA is below the limit of quantification after HCV treatment.
History of malignancy other than pancreatic cancer < 3 years prior to enrolment, except non-melanoma skin cancer or carcinoma in situ of the cervix treated locally or carcinoma in situ considered cured by local treatment
Known hypersensitivity to any component of the RP72 and/or Gemcitabine formulations (including kanamycin or other aminoglycosides)
Subjects that received radiation to ≥ 25% of their bone marrow within 4 weeks of the first dose of study drug.
Evidence of central nervous system (CNS) metastasis. Note: Subjects who have a central nervous system metastasis that has been treated, stable and has not needed treatment for at least 4 weeks at the time of screening will be allowed to enroll in the study.
Subjects that have on-going moderate to severe organ impairment, other than the study indication, that may confound the efficacy evaluation, safety evaluation or usage of standard chemotherapy
Corrected QT interval (QTc) ≥ 470 msec on the 12-lead ECG
The Estimated Number of Participants
-
Taiwan
48 participants
-
Global
48 participants
