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LiPlaCis

Phase 1

Phase 2 Part: Metastatic Breast Cancer, Prostate Cancer and Skin Cancer | Small molecule | Oncology |Allarity Therapeutics, Inc.|Trials Updated: Feb 24, 2022

LiPlaCis development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2013

LiPlaCis target and mechanism

ModalitySmall molecule

Also known as Liposomal formulation of Cisplatinum

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

LiPlaCis clinical trials

LiPlaCis · 1 trial · 2 indications

Phase 1 1
NCT01861496Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory TumoursPhase 1: Advanced or Refractory Solid Tumours
COMPLETED50 Analytics
PHASE1COMPLETED
Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours
Phase 1: Advanced or Refractory Solid TumoursUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD) and recommended dose (RD) by evaluating the safety and tolerability
one year

Primary Objective: Assessment of adverse events and laboratory abnormalities

Secondary Endpoints

Maximum Observed Plasma Concentrations of platinum (Cmax)
Prior to the initial dose on day 1, day 8 and 15 and 5 min before end of infusion, 5 min, 0,5, 1, 3, 7, 24, 48, 72 hours post dose
Concentration of platinum (Pt-DNA)
Prior to the initial dose on day 1and 24 hours after
Area Under the Plasma - Time Concentration Curve (AUC)
Prior to the initial dose on day 1, day 8 and 15 and 5 min before end of infusion, 5 min, 0,5, 1, 3, 7, 24, 48, 72 hours post dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LiPlaCisEXPERIMENTALDose escalation of LiPlaCis - a liposomal formulation of cisplatin will be administered intravenously in cycles every 3 weeks on day 1, day 8. Upon the investigator's judgement the patient may continue treatment for more than 3 cycles when benefiting from the study drug.

Interventions

NameTypeDescription
LiPlaCisDRUGLiPlaCis IV every 3 weeks on day 1, day 8
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histological or cytological documented locally advanced or metastatic solid tumour relapsed on 2 or more different prior therapies. From step 5 and extension phase, population limited to Skin Cancer patients (non screened) or metastatic Breast Cancer patients or metastatic cas...

Countries:Denmark
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Frequently asked questions about LiPlaCis

What is LiPlaCis?

LiPlaCis is an investigational small molecule oncology drug developed by Allarity Therapeutics, Inc. (ticker ALLR). It has been studied in a Phase 1/2 clinical trial in patients with advanced or refractory solid tumors, with a Phase 2 part focused on metastatic breast cancer, prostate cancer and skin cancer.

What is LiPlaCis used for?

LiPlaCis has been studied for the treatment of advanced or refractory solid tumors in its Phase 1 portion, and for metastatic breast cancer, prostate cancer and skin cancer in the Phase 2 part of its clinical program. It is investigational and has not been established as an approved therapy.

Who makes LiPlaCis?

LiPlaCis is developed by Allarity Therapeutics, Inc., which trades under the ticker ALLR. The company sponsored the clinical study evaluating the drug in patients with advanced or refractory tumors.

What phase is LiPlaCis in?

LiPlaCis is in Phase 1 development. Its single clinical trial, NCT01861496, was a Phase 1/2 study, and the program is described as Phase 1. The trial has been completed, and no trials are currently active.

What clinical trials is LiPlaCis in?

LiPlaCis has been evaluated in one clinical trial, NCT01861496, titled a Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours. The trial enrolled 50 patients in Denmark, was uncontrolled, and has been completed.