Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AEB1102, Pegzilarginase
Co-ArgI-PEG · 5 trials · 4 indications
The primary analysis will test the change in the level of plasma arginine between baseline and completion of week 24 assessments. It will compare the change from baseline in plasma arginine between participants treated with pegzilarginase and those treated with placebo.
Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
1\. Number of participants experiencing treatment-related adverse events as assessed by CTCAE v4.0.
1\. Objective Response Rate (ORR:) per RECIST 1.1 • The Objective Response Rate (ORR) is defined as the percentage of subjects whose best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by the Investigator.
| Arm | Type | Description |
|---|---|---|
| Pegzilarginase | EXPERIMENTAL | Weekly IV infusions of pegzilarginase plus individualized disease management for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Weekly IV infusions of placebo plus individualized disease management for 24 weeks |
| Pegzilarginase Long Term Extension | EXPERIMENTAL | After completion of 24 weeks DB treatment, weekly IV infusions of pegzilarginase plus individualized disease management for an additional 150 weeks, with the option to receive treatment by SC after 8 weeks of the LTE study. |
| AEB1102 | EXPERIMENTAL | Each patient may receive AEB1102 administered IV for up to approximately 4 years. |
| AEB1102 Dose Escalation Cohort 1 | EXPERIMENTAL | 3 patients dosed at 0.01 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 2 | EXPERIMENTAL | 4 patients dosed at 0.02 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 3 | EXPERIMENTAL | 4 patients dosed at 0.04 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 4 | EXPERIMENTAL | 4 patients dosed at 0.08 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 5 | EXPERIMENTAL | 3 patients dosed at 0.12 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 6 | EXPERIMENTAL | 4 patients dosed at 0.18 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 7 | EXPERIMENTAL | 5 patients dosed at 0.27 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 8 | EXPERIMENTAL | 7 patients dosed at 0.40 mg/kg until MTD determined |
| AEB1102 Dose Escalation Cohort 9 | EXPERIMENTAL | 7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg |
| AEB1102 Expansion | EXPERIMENTAL | Uveal: 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 |
| Pegzilarginase plus Pembrolizumab | EXPERIMENTAL | Phase 1 \& 2 |
| Name | Type | Description |
|---|---|---|
| Pegzilarginase | DRUG | Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated |
| Placebo | DRUG | Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated |
| AEB1102 | DRUG | modified human arginase I |
| Co-ArgI-PEG | DRUG | Administered IV |
| Pembrolizumab | DRUG | Administered IV |
Inclusion Criteria: Subjects are eligible to be included in the study only if all the following criteria apply: 1. The subject and/or parent/guardian provides written informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
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.
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.
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.
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.
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.