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	Safety as assessed by adverse events (AEs), including serious adverse events (SAEs)	Throughout study period plus 4 weeks, approximately 16 weeks total	Total number of AEs
Primary	Evaluate the Proportion of Patients with Abnormalities in Safety Laboratory Parameters that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab)	Throughout study period plus 4 weeks, approximately 16 weeks total	To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
Primary	Evaluate changes in the electrocardiogram QT interval that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab). [Safety]	Throughout study period plus 4 weeks, approximately 16 weeks total	To evaluate the safety of BC1 as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval
Primary	Evaluate the proportion of patients with abnormal physical examination findings including vital signs	Throughout study period plus 4 weeks, approximately 16 weeks total	To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Physical Examination Findings and Abnormal Vital Signs
Secondary	Tumor response as assessed by Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Throughout study period plus 4 weeks, approximately 16 weeks total	Quantify tumor ORR
Secondary	Tumor response as assessed by Clinical response rate as determined by local standard of care imaging and investigators	Throughout study period plus 4 weeks, approximately 16 weeks total	Determine clinical relevance of tumor response
Secondary	Tumor response as assessed by Non-progressive rate (aka: clinical benefit rate), defined as CR, PR, or stable disease (SD) per RECIST 1.1 and as determined by local standard of care imaging and investigators	Throughout study period plus 4 weeks, approximately 16 weeks total	Quantify change in tumor rate of progression
Secondary	Tumor response as assessed by Duration of response (DoR)	Throughout study period plus 4 weeks, approximately 16 weeks total	Quantify tumor duration of response to therapy
Other	PFS and OS treated with HLA-characterized cellular immunotherapy	Throughout study period plus 4 weeks, approximately 16 weeks total	To evaluate the effect of the BC1 on progression-free survival (PFS) • To assess the single agent activity of the BC1 regimen in the sample cohort using PFS, ORR, and CBR, and changes in circulating tumor cells before and after therapy.
Other	Evaluate Immune Responses	Throughout study period plus 4 weeks, approximately 16 weeks total	Immune responses will be evaluated by known and hypothesized covariates including DTH
Other	Stratified Analysis of Outcomes by HLA type	Throughout study period plus 4 weeks, approximately 16 weeks total	Determine specific HLA type for analysis
Other	Stratified Analysis of Outcomes by Tumor Grade	Throughout study period plus 4 weeks, approximately 16 weeks total	Classify the tumor based on its differentiation: * well-differentiated or Grade 1 * moderately differentiated or Grade 2 * poorly differentiated or Grade 3
Other	Stratified analysis of Circulating Cancer cell or Cancer-associated cell expression of PD-L1, PD-L2, and other selected antigens such as the cancer/testis antigen PRAME	Throughout study period plus 4 weeks, approximately 16 weeks total	Measure the expression relevant antigens on circulating cancer cells or cancer-associated cells, which may predict response to immunotherapy.
Other	Second Progression-Free Survival (PFS2) on subsequent therapy	Throughout study period plus 4 weeks, approximately 16 weeks total	Evaluate effectiveness of subsequent therapy in delaying further progression from the time of randomization to the second disease progression or death from any cause.

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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