RTX-240 Monotherapy

STATUS

Recruiting
participants needed

172
sponsor

Rubius Therapeutics

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Updated on 19 February 2024

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cancer

platelet count

solid tumour

solid tumor

Summary

Open label, multicenter, multidose, first-in-human Phase 1/2 study of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors.

Description

This is a Phase 1/2, open label, multicenter, multidose, first-in-human (FIH) dose escalation and expansion to determine the safety and tolerability, recommended phase 2 dose and optimal dosing interval, pharmacology, and antitumor activity of RTX-240 in adult patients with relapsed/refractory or locally advanced solid tumors. RTX-240 is a cellular therapy that co-expresses 4-1BBL and IL-15TP, a fusion of IL-15 and IL-15 receptor alpha, with the goal of harnessing the innate and adaptive immune systems for the treatment of cancer. The study will include a monotherapy dose escalation phase followed by an expansion phase in specified tumor types.

Details

Condition	Solid Tumor, Adult
Age	18years - 100years
Treatment	RTX-240
Clinical Study Identifier	NCT04372706
Sponsor	Rubius Therapeutics
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed written informed consent obtained prior to study procedures
	Patients 18 years with an ECOG 0 or 1
	Relapsed/Refractory or locally advanced, unresectable solid tumor for which no standard therapy exists, or for which the patient is ineligible or has declined standard therapy
	Disease must be measurable per Response Evaluation Criteria
	The shorter of 28 days or 5 half-lives must have elapsed since the completion of prior therapy, before initiation of study treatment
	Positive antibody screen using institution's standard type and screen test
	Adequate Organ Function as Defined by the protocol
	GFR 50 mL/min/1.73
	AST and ALT 3 the ULN and total bilirubin 1.5 ULN
	In the absence of cancer within the liver, or AST and ALT 5 ULN and total bilirubin 3 ULN, in the setting of primary or metastatic liver tumors
	ANC 10 103/L and platelet count 100 103/L without myeloid growth factor support or transfusion, respectively, for at least one week
	Hemoglobin should be 9 g/dL without red blood cell transfusion for at least two weeks
	Patients must have LVEF 45%
	Patients enrolling into Part 2 of the study must be diagnosed with a solid tumor that has been selected for an expansion cohort
Exclusion Criteria
	Primary CNS malignancy or central nervous system (CNS) involvement, unless asymptomatic, previously treated, and stable without steroids
	Known hypersensitivity to any component of study treatment or excipients
	Positive antibody screen using institution's standard type and screen test
	Clinically significant, active and uncontrolled infection, including human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
	Clinically significant coagulopathy, uncontrolled hypertension or autoimmune hemolytic anemia
	Concomitant conditions requiring active immunosuppression
	Grade 3 immune related Adverse Event (irAE)
	Prior malignancy within the past 3 years, with protocol specified exceptions

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Study Definition

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RTX-240 Monotherapy