Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Phase I-Number of patients experience Dose limiting toxicity (DLT)	42 days	Defined as the maximum dose safely administered intravenously or Intracavitary for the treatment of patients with GBM
Primary	To establish maximum tolerated dose (MTD) and a Recommended Phase 2a Dose (RP2D)	42 days	Defined as the number of patients experience Adverse Events and severity
Primary	Phase IIa CYNK-001 efficacy	6 Months	To evaluate CYNK-001 efficacy post tumor resection and survival within PFS6 Month
Secondary	Phase 1-Progression free survival at 6 Months	6 Months	is defined as the time from the tumor resection to the date of first documented disease progression determined in accordance with RANO (and iRANO) or death due to any reason, whichever occurs first
Secondary	Overall survival phase I and IIa	6,9 and 12 months	is defined as the time from the tumor resection until the date of death at 6,9 and 12 months
Other	Progression Free survival Phase I and IIa	9 and 12 months	is defined as the time from the tumor resection until the date of death 9 and 12 months (PFS9 and PFS12) post tumor resection
Other	Median Progression Free Survival (mPFS) post tumor resection	6, 9,12 , 18 and 24 months	is defined as the median 95% CIs time from the tumor resection until the date of death 9 and 12 months (PFS9 and PFS12) post tumor resection
Other	Median Overall Survival (mOS) post tumor resection	12 and 24 months	is defined as the median as the 95%CI time from the tumor resection until the date of death.
Other	Time to Progression (TTP) as measured by RANO	12 and 24 months	is defined as the time from the tumor resection to the date of first documented disease progression determined in accordance with RANO(iRANO).
Other	Overall Response Rate (ORR) pre and post tumor resection as measured by RANO	12 and 24 months	Defined as the proportion of subjects with best overall response of either complete response (CR) or partial response (PR)
Other	Health Quality of Life assessment using European Organization for Research and Treatment of Cancer-30 with Brain20 module scores	22, 43, 64,92,120 days	To assess patient quality of life at baseline and post tumor resection surgery per the schedule of Events using EORTC QLQ C30 and EORTC QLQ BN 20 scale
Other	Evaluation of Neurological Assessment of the Neuro Oncology Scale in Glioblastoma (NANO	22, 43, 64,92,120 days	NANO scale provides an objective clinician-reported outcome of neurologic function with high inter-observer agreement
Other	Incidence of Treatment Emergent adverse events (TEAE)	26 months	any event not present prior to the initiation of the drug treatment
Other	Incidence and Severity of adverse events (AEs) and clinically significant changes in laboratory values	26 months	any untoward or unfavorable medical occurrence in patient during the clinical trial

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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