Pancreatic CancerPhase 1NCT04338763
RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
A Phase 1 study testing RP72 and Gemcitabine in people with Pancreatic Cancer and Pancreatic Cancer Non-resectable, run by Rise Biopharmaceuticals, Inc. at 2 sites in Taiwan.
Trial summary
This is a Phase I, multi center study to evaluate the safety and efficacy and determine the maximum tolerated dose (MTD) of RP72 as monotherapy and RP72 in combination with Gemcitabine in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Cancer Non-resectable, Pancreatic Cancer Metastatic
- What is being tested?
- RP72 and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Apr 2021to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Chi Mei Hospital, Liouying
Tainan
Cheng-Yao Lin, M.D., d930827@mail.chimei.org.tw
Cheng-Yao Lin
- Recruiting
National Cheng Kung University Hospital
Tainan
Yan-Shen Shan, M.D.-Ph.D, ysshan@ncku.edu.tw
Yan-Shen Shan, M.D.-Ph.D
About this study
Official title: A Phase I Study to Evaluate the Safety and Efficacy of RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
This is a Phase I, multi center study to evaluate the safety and efficacy and determine the maximum tolerated dose (MTD) of RP72 as monotherapy and RP72 in combination with Gemcitabine in patients with pancreatic cancer.
The study has two arms:
Arm A: RP72 monotherapy
Arm B: RP72 in combination with Gemcitabine
Both treatment arms will follow a standard 3+3 design. Up to 48 adult patients with pancreatic cancer will be enrolled in this study.
Read the detailed description
RP72 (Rise Prot-72) is a small molecular weight protein which directly binds to CXCR1 and CXCR2, which are the receptors of CXCL8 [Interleukin 8 (IL-8) or chemokine (C-X-C motif) ligand 8] and ELR-CXC chemokine. Therefore, RP72 can inhibit the binding of CXCL8 to its receptors CXCR1/2 and further block CXCL8-mediated signal transduction. Nonclinical studies have demonstrated that RP72 binds to the receptors of CXCL8 and blocks activation of CXCL8-mediated signaling transduction pathways, which decreases proliferation of susceptible tumor cells, especially the pancreatic cancer cells.
In this Phase I study, RP-72 will be used as monotherapy or in combination with gemcitabine in adult patients with pancreatic cancer. The study aims to to evaluate the safety and efficacy, and to determine the MTD and recommended Phase II dose of RP72 monotherapy and RP72 in combination with Gemcitabine in patients with Pancreatic Cancer.
- Being tested
- RP72, Gemcitabine
- Keywords
- Pancreatic Cancer, RP72, Rise Prot-72
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP72Drug
Also called Rise Prot-72
RP72 is formulated as a sterile lyophilized powder which is reconstituted in sterile water for injection (WFI) prior to administration. IV injection of RP72 will be administered thrice weekly in the first 28-day treatment cycle (Cycle 1). RP72 will continue to be administered thrice weekly for 4 weeks for Cycle 2 and each subsequent 28-day treatment cycle.
GemcitabineDrug
Gemcitabine is an anti-cancer chemotherapy drug. IV infusion of Gemcitabine will be administered once weekly in the first 28-day treatment cycle (Cycle 1). Gemcitabine will continue to be administered once weekly for the first 3 weeks and then one week rest in Cycle 2 and each subsequent 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: RP72 monotherapy | Experimental | Not described Receives: Drug: RP72 |
| Arm B: RP72 in combination with Gemcitabine | Experimental | Not described Receives: Drug: RP72; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the maximum tolerated dose (MTD) and the recommended dose for phase II of RP72 monotherapy and RP72 in combination with Gemcitabine
The MTD is defined as 1 dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in ≥ 33% of the participants.
Measured: Over the 28 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start19 Apr 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rise Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- T-TOP Clinical Research Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338763
- Sponsor's protocol ID
- RP-72-002
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Efficacy of RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04338763
- Acronym / sponsor ID
- RP-72-002
- Keywords
- Pancreatic Cancer, RP72, Rise Prot-72
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rise Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- T-TOP Clinical Research Co., Ltd.
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, multi center study to evaluate the safety and efficacy and determine the maximum tolerated dose (MTD) of RP72 as monotherapy and RP72 in combination with Gemcitabine in patients with pancreatic cancer.
The study has two arms:
Arm A: RP72 monotherapy
Arm B: RP72 in combination with Gemcitabine
Both treatment arms will follow a standard 3+3 design. Up to 48 adult patients with pancreatic cancer will be enrolled in this study.
Detailed description
RP72 (Rise Prot-72) is a small molecular weight protein which directly binds to CXCR1 and CXCR2, which are the receptors of CXCL8 [Interleukin 8 (IL-8) or chemokine (C-X-C motif) ligand 8] and ELR-CXC chemokine. Therefore, RP72 can inhibit the binding of CXCL8 to its receptors CXCR1/2 and further block CXCL8-mediated signal transduction. Nonclinical studies have demonstrated that RP72 binds to the receptors of CXCL8 and blocks activation of CXCL8-mediated signaling transduction pathways, which decreases proliferation of susceptible tumor cells, especially the pancreatic cancer cells.
In this Phase I study, RP-72 will be used as monotherapy or in combination with gemcitabine in adult patients with pancreatic cancer. The study aims to to evaluate the safety and efficacy, and to determine the MTD and recommended Phase II dose of RP72 monotherapy and RP72 in combination with Gemcitabine in patients with Pancreatic Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: RP72 monotherapy | Experimental | Drug: RP72 |
| Arm B: RP72 in combination with Gemcitabine | Experimental | Drug: RP72, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP72Also: Rise Prot-72RP72 is formulated as a sterile lyophilized powder which is reconstituted in sterile water for injection (WFI) prior to administration. IV injection of RP72 will be administered thrice weekly in the first 28-day treatment cycle (Cycle 1). RP72 will continue to be administered thrice weekly for 4 weeks for Cycle 2 and each subsequent 28-day treatment cycle. | Drug | Arm A: RP72 monotherapy, Arm B: RP72 in combination with Gemcitabine |
| GemcitabineGemcitabine is an anti-cancer chemotherapy drug. IV infusion of Gemcitabine will be administered once weekly in the first 28-day treatment cycle (Cycle 1). Gemcitabine will continue to be administered once weekly for the first 3 weeks and then one week rest in Cycle 2 and each subsequent 28-day treatment cycle. | Drug | Arm B: RP72 in combination with Gemcitabine |
Primary outcome
Determination of the maximum tolerated dose (MTD) and the recommended dose for phase II of RP72 monotherapy and RP72 in combination with Gemcitabine
Time frame: Over the 28 day treatment period
The MTD is defined as 1 dose level (cohort) below the dose in which dose limiting toxicities (DLTs) were observed in ≥ 33% of the participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP72 and Gemcitabine in people with Pancreatic Cancer and Pancreatic Cancer Non-resectable, run by Rise Biopharmaceuticals, Inc. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen Wang, Master (+886-2-2351-1190 ext. 217, Helen.Wang@ttopcro.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the maximum tolerated dose (MTD) and the recommended dose for phase II of RP72 monotherapy and RP72 in combination with Gemcitabine (time frame: Over the 28 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.