Registered outcomes15

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

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Incidence of Adverse Events (AEs)	6 months	Measured by the number of patients with AEs in Phase 1 portion of the study.
Primary	Anti-tumor activity of AVB-S6-500 in combination with PLD	18 months	Measured by progression free survival (PFS) in patients receiving AVB-S6-500+PLD versus patients receiving Placebo+PLD in Phase 2 portion of the study.
Primary	Anti-tumor activity of AVB-S6-500 in combination with Pac	18 months	Measured by progression free survival (PFS) in patients receiving AVB-S6-500+ Pac versus patients receiving Placebo+Pac in Phase 2 portion of the study.
Secondary	Pharmacokinetics: AUC	18 months	Area under the AVB-S6-500 concentration-time curve.
Secondary	Pharmacokinetics: Cmax	18 months	Maximum observed AVB-S6-500 concentration.
Secondary	Pharmacokinetics: Tmax	18 months	Time of maximum observed AVB-S6-500 concentration.
Secondary	Pharmacokinetics: t1/2	18 months	Apparent terminal half-life of AVB-S6-500.
Secondary	Pharmacodynamic marker assessment	18 months	Change from the baseline in GAS6 serum levels.
Secondary	Anti-drug antibody (ADA) titers	18 months	Change from baseline in ADA titer.
Secondary	Objective response rate	18 months	Proportion of subjects who have a partial or complete response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as well as Gynecologic Cancer Intergroup (GCIG) cancer antigen (CA)-125 criteria.
Secondary	Disease control rate	18 months	Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Secondary	Duration of response (DOR)	18 months	Measured from the date of partial or complete response to therapy until the cancer progresses.
Secondary	Overall survival	30 months	Time following the treatment until death.
Secondary	CA-125 response rate	18 months	Proportion of subjects with a minimum 50% reduction in CA-125 serum levels lasting for 28 days relative to baseline CA-125 serum levels.
Secondary	Quality of Life(QOL)	18 months	Subject QOL will be assessed every 8 weeks during treatment using the Functional Assessment Of Cancer Therapy - Ovarian Cancer (FACT-O) questionnaire, which consists of 4 subscales: physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7 questions), and 12 additional concerns specific to ovarian cancer. All items are rated on a 5 point scale with 0 "not at all" and 4 "very much". The scoring algorithm allows for eight summary scales: the four core well-being subscales, a subtotal of the 27 core items, a subtotal of the 12 ovarian-specific additional concerns, a grand total of the 39 items, and a trial outcome index (sum of the 17 physical and functional wellbeing items plus the 12 ovarian-specific items).

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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GET https://conductscience.org/api/trials/v1/NCT03639246/registered

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