Trials / Unknown
UnknownNCT04338763
RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
A Phase I Study to Evaluate the Safety and Efficacy of RP72 Monotherapy and in Combination With Gemcitabine in Patients With Pancreatic Cancer
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Rise Biopharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RP72 | 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. |
| DRUG | Gemcitabine | 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. |
Timeline
- Start date
- 2021-04-19
- Primary completion
- 2024-10-31
- Completion
- 2025-12-31
- First posted
- 2020-04-08
- Last updated
- 2023-11-18
Locations
2 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04338763. Inclusion in this directory is not an endorsement.