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	Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)	The first two cycles (Cycle 1 and Cycle 2) of the study treatment(s). A cycle lasted for two weeks (14 days) in the study.	DLT was defined as the adverse events (AEs) listed in the protocol occurring within 4 weeks (the first 2 cycles, 28 days) after the investigational drugs which were at least possibly related to the study drugs. AE severity was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Primary	Phase 1 and Phase 2: Safety	AEs would be collected throughout the clinical trial, from the signing of the informed consent form (ICF) to the end of the trial (until 30 days after the last dose of investigational drugs). Up to approximately 24 months.	All adverse events (AEs) occurring on or after the first study treatment were listed and summarized. Treatment-Emergent Adverse Event (TEAE) was defined as an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment (any component of combination treatment whichever was last) discontinuation. All adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Primary	Phase 2: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) According to RECIST 1.1	Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method.
Secondary	Phase 2: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method.
Secondary	Phase 2: Disease Control Rate (DCR) by BICR / Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at basline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	DCR was defined as the percentage of participants who attained a best overall response status of CR, PR, and SD. If best overall response is SD, the SD should be stable SD, that is the date of SD should be at least 6 weeks after first dose. DCR was analyzed using the same methodology as specified for ORR.
Secondary	Phase 2: Time to Response (TTR) by Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	TTR was defined as the time from the first dose date to the date of the earliest confirmed response assessed using RECIST V1.1. Only responders were included in the analysis.
Secondary	Phase 2: Duration of Response (DoR) by Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	DoR was defined for subjects with a confirmed objective response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurred first. Participants who had no progression or death would be censored.
Secondary	Phase 2: Progression-Free Survival (PFS) by Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	PFS was defined as the time from the date of first dose of study treatment (any component of combination treatment whichever is first) to the first documented disease progression as determined by the investigator or BICR with the use of RECIST v1.1, or death from any cause, whichever occurred first. Kaplan-Meier methodology was used to estimate the median PFS for each treatment arm and to construct survival curves for each treatment arm. The Brookmeyer-Crowley methodology was used to construct the 95% CI for the median PFS for each treatment arm (Brookmeyer and Crowley 1982).
Secondary	Phase 2: Overall Survival (OS)	From the date of the first dose of study treatment to the date of death from any cause. Up to approximately 24 months.	OS was defined as the time from the date of the first dose of study treatment (any component of combination treatment whichever was first) to the date of death from any cause. Participants who were alive at the time of the analysis data cutoff would be censored at the last date they were known to be alive. Participants with no post-baseline information were censored at the date of the first dose of study treatment (any study treatment component for combo therapy).
Secondary	Phase 1: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method.
Secondary	Phase 1: Disease Control Rate (DCR) by Investigator Assessment According to RECIST 1.1	Radiologic examinations were conducted at basline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.	DCR was defined as the percentage of participants who attained a best overall response status of CR, PR, and SD. If best overall response is SD, the SD should be stable SD, that is the date of SD should be at least 6 weeks after first dose. DCR was analyzed using the same methodology as specified for ORR.

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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