| Primary | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT) | DLTs were defined for a list of predefined study medication-related adverse events (AEs) as specified in the protocol, according to the National Cancer Institute - Common Terminology Criteria for Adverse Events scale version 5.0 that occurred during the defined DLT assessment period (during Cycle 1 or 2). | Safety population contained all participants who received at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | No | From the start of the first study medication (Cycle 1 Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG003 | Cohort 4: 177Lu-3BP-227 6.5 GBq | Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG004 | Cohort 5: 177Lu-3BP-227 7.5 GBq | Participants received 177Lu-3BP-227 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Maximum Uptake (%) of 177Lu-3BP-227 at Target Lesions and Discernible Organs | 177Lu-3BP-227 uptake in organs and lesions was evaluated centrally, using nuclear medicine images, as part of the dosimetry workflow. Uptake activity for organs of interest (i.e., body, bone marrow, left kidney, right kidney, healthy liver, and spleen) was determined. The uptake activity was expressed relatively to the injected 177Lu-3BP-227 activity calculated as the ratio of the uptake activity divided by the administered activity at the time of injection. | Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since the study drug administered to different groups had same composition/specific activity, no difference in drug distribution was expected between groups. Because uptake results were expressed as percentage of administered 177Lu-3BP-227 activity, no difference in uptake was expected between groups and results were reported combining all groups. | Posted | | Median | Full Range | percentage of injected 177Lu-3BP-227 | | Measurements were performed at 0 to 1 hours, 2 to 4 hours, 16 to 24 hours, 40 to 48 hours, 72 to 96 hours post infusion in each treatment cycle. | Observations | Observations | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Maximal Concentration (Cmax) of 177Lu-3BP-227 | The pharmacokinetic (PK) sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Time Post Injection to Achieve Cmax of 177Lu-3BP-227 | The PK sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of 177Lu-3BP-227 | The PK sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Half-life (t1/2) of 177Lu-3BP-227 | The PK sampling was performed from Day 1 to Day 5 post infusion for each treatment cycle. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 24 hours, 48 hours and 72 to 96 hours post infusion in each treatment cycle. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Number of Participants With Highest Absorbed Dose of 177Lu-3BP-227 to Each Discernible Organ | The absorbed dose to the target lesions and discernible organs (i.e., organs showing uptake) was evaluated by image-based analysis. The organs considered for 177Lu-3BP-227 image-based dosimetry assessment included: healthy liver, total liver, bone marrow, left kidney, right kidney, intestine (large and small), spleen, pancreas, stomach wall, right ovary, left ovary, uterus, right testis, left testis, thymus, right thyroid gland, left thyroid gland, prostate gland and total body. The organ that had the highest absorbed dose of treatment for each participant in each treatment cycle was determined. | Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since the study drug administered to the different groups had the same composition/specific activity, no difference in drug distribution was expected between groups and results were reported combining all groups. | Posted | | Count of Participants | | Participants | No | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Specific Absorbed Dose to the Target Lesions of 177Lu-3BP-227 | The specific absorbed dose to the target lesions was evaluated by image-based analysis. Results for all studied diseases (pancreatic ductal adenocarcinoma and colorectal carcinoma) at all anatomical locations (cervical, intrapelvic, liver, lung, lymph node, and pancreas) for all cycles (Cycle 1 and 2) are reported. The specific absorbed dose (Gray/GBq) was calculated as the absorbed dose to the target lesions (in Gray) divided by the activity of 177Lu-3BP-227 administered (in GBq). | Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since study drug administered to different groups had same composition/specific activity and since the specific absorbed dose is expressed relatively to the administered activity (Gray/Gbq), no difference in specific absorbed dose was expected between groups and results were reported combining all groups. | Posted | | Median | Full Range | Gray/GBq | | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | Lesions | Lesions | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Specific Absorbed Dose Per Organ of 177Lu-3BP-227 | The specific absorbed dose per organ was evaluated by image-based analysis. The specific absorbed dose (Gray/GBq) was calculated as the absorbed dose to an organ (in Gray) divided by the activity of 177Lu-3BP-227 administered (in GBq). | Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Since study drug administered to different groups had same composition/specific activity and since the specific absorbed dose is expressed relatively to the administered activity (Gray/Gbq), no difference in specific absorbed dose was expected between groups and results were reported combining all groups. | Posted | | Median | Full Range | Gray/GBq | | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | Observations of injected 177Lu-3BP-227 | Observations of injected 177Lu-3BP-227 | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Cumulative Absorbed Organ Doses of 177Lu-3BP-227 | The cumulative absorbed dose to the discernible organs (i.e., organs showing uptake) was evaluated by image-based analysis. | Dosimetry population included all participants with organ dosimetry data and with no major protocol deviations with an impact on dosimetry analysis. Cumulative absorbed doses on Cycles 1 and 2 are only presented for participants who have performed the 2 cycles. | Posted | | Median | Full Range | Gray | | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | |
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| Secondary | Phase 1: Cmax of 3BP-227 | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: AUC of 3BP-227 | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: t1/2 of 3BP-227 | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Clearance of 3BP-227 | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Volume of Distribution of 3BP-227 | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Cumulative Amount of Unchanged 3BP-227 Excreted Into the Urine | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Renal Clearance of 3BP-227 From Plasma | The PK sampling was performed from Day 1 to Day 3 post infusion of 177Lu-3BP-227 in Cycle 1. | Due to the early termination of the study, the PK analysis data was not collected. | Posted | | | | | | Pre-infusion and at the end of infusion, and 5 minutes, 30 minutes, 90 minutes, 4 hours, 6 hours, 8 hours, 24 hours and 48 hours post infusion of 177Lu-3BP-227 in Cycle 1. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Number of Participants With Objective Response Rate (ORR) | The ORR was defined as number of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) relative to the total number of evaluable participants. | Primary Pharmacodynamic population (for tumor response) included all participants who received at least 2 therapeutic doses of 177Lu-3BP-227 and reached the end of Cycle 2 or EOCT visit with available post-baseline tumor assessment based on RECIST 1.1 and with no major protocol deviations with an impact on the analysis. | Posted | | Count of Participants | | Participants | No | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | |
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| Secondary | Phase 1: Number of Participants With Disease Control Rate (DCR) | The DCR was defined as number of participants with a BOR characterized as CR, PR or stable disease according to RECIST 1.1 relative to the total number of evaluable participants. | Primary Pharmacodynamic population (for tumor response) included all participants who received at least 2 therapeutic doses of 177Lu-3BP-227 and reached the end of Cycle 2 or EOCT visit with available post-baseline tumor assessment based on RECIST 1.1 and with no major protocol deviations with an impact on the analysis. | Posted | | Count of Participants | | Participants | No | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Progression-Free Survival (PFS) | The PFS was defined as the time from date of first study medication administration until progression, according to RECIST 1.1. | Due to the early termination of the study, survival analysis on PFS was not collected. | Posted | | | | | | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG003 | Cohort 4: 177Lu-3BP-227 6.5 GBq | Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Overall Survival (OS) | The OS was defined from first study medication administration until death, according to RECIST 1.1. | Due to the early termination of the study, survival analysis on OS was not collected. | Posted | | | | | | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG003 | Cohort 4: 177Lu-3BP-227 6.5 GBq | Participants received 177Lu-3BP-227 6.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Metabolic Tumor Response Using Positron Emission Tomography (PET) Response Criteria In Solid Tumors (PERCIST) Version 1.0 or Practical PERCIST | Tumor response assessments were planned to perform by the site investigator (local) for the phase 1 and dose escalation part and by independent reader (central) for the phase 2. All fluorine-18 fluorodeoxyglucose-PET images were used for the metabolic tumor response assessments as described in PERCIST version 1.0 by the Investigator and/or independent readers. | Due to the early termination of the study, metabolic tumor response was not collected. | Posted | | | | | | From the start of the first study medication (Day 1) up to EOCT, maximum of 16 weeks. | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received 177Lu-3BP-227 dose range of 2.5 to 7.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. |
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| Secondary | Phase 1: Tumor Marker Levels in Serum - Cancer Antigen 19-9 | Changes in tumor markers in serum relevant and specific to the underlying tumor disease was determined. | Pharmacodynamic population included all participants who received at least 1 therapeutic dose and with available post-baseline pharmacodynamics/efficacy data. | Posted | | Mean | Standard Deviation | international units/milliliter | | Cycle 1 Day 1, Cycle 2 Day 1, EOCT (maximum of 16 weeks) and early withdrawal | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG003 | Cohort 4: 177Lu-3BP-227 6.5 GBq |
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| Secondary | Phase 1: Tumor Marker Levels in Serum - Carcinoembryonic Antigen | Changes in tumor markers in serum relevant and specific to the underlying tumor disease was determined. | Pharmacodynamic population included all participants who received at least 1 therapeutic dose and with available post-baseline pharmacodynamics/efficacy data. | Posted | | Mean | Standard Deviation | microgram per liter | | Cycle 1 Day 1, Cycle 2 Day 1, EOCT (maximum of 16 weeks) and early withdrawal | | | | ID | Title | Description |
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| OG000 | Cohort 1: 177Lu-3BP-227 2.5 GBq | Participants received 177Lu-3BP-227 2.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG001 | Cohort 2: 177Lu-3BP-227 4.0 GBq | Participants received 177Lu-3BP-227 4.0 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG002 | Cohort 3: 177Lu-3BP-227 5.5 GBq | Participants received 177Lu-3BP-227 5.5 GBq fractionated into 2 IV administrations separated by 4 to 5 weeks during the core trial period. | | OG003 | Cohort 4: 177Lu-3BP-227 6.5 GBq |
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