Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Number of participants with adverse events (AE) and serious adverse events (SAE)	Through study completion, an average of 3 years	To assess the safety and tolerability
Primary	Objective response rate (ORR)	Through study completion, an average of 3 years	ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1
Secondary	Best Overall Response(BOR)	Through study completion, an average of 3 years	BOR is the best response a participant has had following randomisation/start of dosing, but prior to starting any subsequent cancer therapy and up to and including RECIST progression or the last evaluable assessment in the absence of RECIST progression
Secondary	Change in Target Lesion Tumor Size	Through study completion, an average of 3 years	The best percentage change from baseline in Target Lesion tumour size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST 1.1 assessments
Secondary	Progression free survival (PFS)	Through study completion, an average of 3 years	PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) per RECIST 1.1.
Secondary	Disease Control Rate(DCR) at 12 Weeks	From Day 1 pre-dose to 12 weeks	DCR at 12 weeks is defined as the percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 11 weeks after start of treatment (to allow for an early assessment within the assessment window).
Secondary	Duration Of Response (DoR)	Through study completion, an average of 3 years	The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).
Secondary	Overall Survival(OS)	Through study completion, an average of 3 years	OS is defined as the time from the start of treatment until death due to any cause.
Secondary	Serum concentration	Through study completion, an average of 3 years	To assess the serum concentration of the novel anti-cancer agents in combination.
Secondary	Maximum plasma drug concentration (Cmax)	Through study completion, an average of 3 years	To assess the Cmax of the novel anti-cancer agents in combination.
Secondary	Immunogenicity of study interventions in participants receiving treatment	Through study completion, an average of 3 years	Presence of Anti Drug Antibodies（ADAs) for study interventions in serum/plasma

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/NCT07098338/registered

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