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1. Compare the objective response rate (ORR) assessed per RANO criteria by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy (Time Frame - Up to 60 months): ORR, per RANO criteria, defined as the proportion of patients with overall confirmed response of complete response (CR) or partial response (PR)
Secondary outcome:
1. Compare the progression-free survival (PFS) assessed by IRC of DAY101 monotherapy versus SoC chemotherapy per RANO criteria (Time Frame - Up to 60 months): PFS per RANO criteria, defined as time from randomization to PD or death from any cause
2. Compare the duration of response (DOR) assessed by IRC of DAY101 monotherapy versus SoC chemotherapy per RANO criteria (Time Frame - Up to 60 months): DOR per RANO criteria, defined as time from confirmed response to PD or death from any cause for patients with confirmed response
3. Compare the overall survival (OS) of DAY101 monotherapy versus SoC chemotherapy (Time Frame - Up to 60 months): OS, defined as time from randomization up to death from any cause
4. Compare the safety and tolerability of DAY101 monotherapy versus SoC chemotherapy (Time Frame - Up to 60 months): Type, frequency, and severity of treatment-emergent adverse events
5. Compare the safety and tolerability of DAY101 monotherapy versus SoC chemotherapy (Time Frame - Up to 60 months): Measured by incidence of clinically significant laboratory abnormalities
6. Compare changes in neurological function between DAY101 versus SoC (Time Frame - Up to 60 months): Change from baseline in the Vineland Adaptive Behavior Composite Scales [age-adjusted standard scores range between 20 to 140, with a mean of 100 and standard deviation of 15, and lower scores indicate worse functional outcomes]
7. Compare changes in visual function outcomes of DAY101 monotherapy versus SoC chemotherapy in patients with optic pathway glioma (OPG) (Time Frame - Up to 60 months): Measured by Teller Acuity Cards® or alternative
8. Compare the ORR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO criteria (Time Frame - Up to 60 months): ORR, defined as the proportion of patients with overall confirmed response per RANO
9. Compare the ORR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria (Time Frame - Up to 60 months): ORR, defined as the proportion of patients with overall confirmed response per RAPNO
10. Compare the clinical benefit rate (CBR) of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO and RAPNO criteria (Time Frame - Up to 60 months): CBR, defined as the proportion of patients with radiological tumor stabilization or regression per RANO or RAPNO criteria, as applicable
11. Compare time to response (TTR) of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO and RAPNO criteria (Time Frame - Up to 60 months): Measured by the time to first response following initiation of therapy in patients with best overall confirmed response per RANO or RAPNO criteria, as applicable
12. Compare the PFS of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO and RANO criteria (Time Frame - Up to 60 months): PFS per RANO or RAPNO (as applicable), defined as time from randomization to progressive disease (PD) or death from any cause
13. Compare the DOR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO and RANO criteria (Time Frame - Up to 60 months): DOR, defined as time from confirmed response to PD or death from any cause for patients with confirmed response per RANO or RAPNO criteria, as applicable
Active Comparator: Arm #2 Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas:
Children's Oncology Group - Vincristine/Carboplatin (COG-V/C)
International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C)
Vinblastine (VBL)
