RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer

NCT04338763 | Unknown Phase 1 FDA Drug

• 1 other identifier: RP-72-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pancreatic Cancer; Pancreatic Cancer Non-resectable; Pancreatic Cancer Metastatic

Keywords

Pancreatic Cancer; RP72; Rise Prot-72

Outcome Measures

Primary Outcomes (1)

• 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.

  Over the 28 day treatment period

Study Arms (2)

Arm A: RP72 monotherapy

EXPERIMENTAL

Drug: RP72

Arm B: RP72 in combination with Gemcitabine

EXPERIMENTAL

Drug: RP72; Drug: Gemcitabine

Interventions

RP72 DRUG

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.

Also known as: Rise Prot-72

Arm A: RP72 monotherapy; Arm B: RP72 in combination with Gemcitabine

Gemcitabine DRUG

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.

Arm B: RP72 in combination with Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rise Biopharmaceuticals, Inc.: lead
• T-TOP Clinical Research Co., Ltd.: collaborator

Study Sites (2)

Chi Mei Hospital, Liouying

Tainan, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Helen Wang, Master

CONTACT

+886-2-2351-1190; Helen.Wang@ttopcro.com.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: April 19, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)