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Co-ArgI-PEG

Phase 1

Advanced Cancers | Small molecule | Oncology |Spyre Therapeutics, Inc.|Last Updated: Nov 5, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

Co-ArgI-PEG · 1 trial · 1 indication

Phase 1 1
NCT02561234A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid TumorsAdvanced Cancers
COMPLETED98 Analytics
PHASE1COMPLETED
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors
Advanced CancersUnlock trial analytics

Study Endpoints

Primary Endpoints

maximum tolerated dose
4 weeks

the dose level at which no more than 1/6 patients experiences dose-limiting toxicity

Secondary Endpoints

safety profile (changes in physical exam, laboratory measures, reported adverse events)
4 weeks +
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEB1102 Dose Escalation Cohort 1EXPERIMENTAL3 patients dosed at 0.01 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 2EXPERIMENTAL4 patients dosed at 0.02 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 3EXPERIMENTAL4 patients dosed at 0.04 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 4EXPERIMENTAL4 patients dosed at 0.08 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 5EXPERIMENTAL3 patients dosed at 0.12 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 6EXPERIMENTAL4 patients dosed at 0.18 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 7EXPERIMENTAL5 patients dosed at 0.27 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 8EXPERIMENTAL7 patients dosed at 0.40 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 9EXPERIMENTAL7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg
AEB1102 ExpansionEXPERIMENTALUveal: 11 patients dosed at 0.33 mg/kg Cutaneous Melanoma: 11 dosed at 0.33 mg/kg SCLC: 13 patients dosed at 0.33 mg/kg

Interventions

NameTypeDescription
Co-ArgI-PEGDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: For patients participating in any part of the trial: * has an advanced solid tumor previously treated with, or inability to tolerate, standard therapy for the disease, or for which a standard therapy does not exist, and as such is considered a candidate for Phase 1 treatment * ...

Countries:United States
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Frequently asked questions about Co-ArgI-PEG

What is Co-ArgI-PEG used for?

Co-ArgI-PEG is an investigational small molecule being developed for the treatment of advanced cancers. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients with advanced solid tumors.

Who makes Co-ArgI-PEG?

Co-ArgI-PEG is being developed by Spyre Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SYRE. The company is conducting clinical research to evaluate the drug's potential in oncology, specifically for patients with advanced cancers.

What phase is Co-ArgI-PEG in?

Co-ArgI-PEG is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 98 patients with advanced solid tumors. The drug is still investigational and has not received FDA approval, as it remains in the early stages of clinical testing.

What clinical trials is Co-ArgI-PEG in?

Co-ArgI-PEG has one completed clinical trial registered under NCT02561234, titled "A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors." This Phase 1 study enrolled 98 participants in the United States and evaluated the drug in patients with advanced cancers.

Is Co-ArgI-PEG the same as AEB1102?

Yes, Co-ArgI-PEG is also known as AEB1102. The completed Phase 1 clinical trial NCT02561234, which evaluated the drug in patients with advanced solid tumors, used the name AEB1102 in its title. Both names refer to the same investigational small molecule being developed by Spyre Therapeutics.