A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.

All participants according to the study treatment assigned (Intent to Treat Population) for participants with mCRPC in Part 1 only. This outcome measure applies to Part 1 only. Per protocol, participants in Part 2 did not have mCRPC and were not part of this analysis.

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primary · POSTED

The ORR is defined as the percentage of participants in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST version 1.1 criterial CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.

All participants who received at least one dose of study treatment and had RECIST-evaluable disease per RECIST v1.1 (Tumor Response Evaluable Population) in Part 2 of the study.

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secondary · POSTED

To qualify as an objective response, CR and PR require confirmation at least 4 weeks after initial observation of complete response (CR) or partial response (PR). CR + PR = ORR

The analysis is limited to only participants with mCRPC who experienced a complete or partial response to study treatment. None of the participants in the control arm experienced a complete or partial response to study treatment. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.

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secondary · POSTED

The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.

All participants with mCRPC who achieved a confirmed complete or partial response to study treatment. No participants in the control group had a complete or partial response. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.

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secondary · POSTED

Part 1: Mean Best Tumor Size Change Over Time

All participants with mCRPC who received at least one dose of study treatment and had RECIST-evaluable disease per PCWG3 (Tumor Response Evaluable Population) in Part 1 of the study. Participants in Part 2 of the study did not have mCRPC and are excluded from this analysis.

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secondary · POSTED

PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.

All participants in Part 1 who received at least one dose of study treatment, with a baseline PSA ≥ 2 ng/mL and at least one post-baseline PSA measurement (PSA Response Evaluable Population). There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-small-cell-lung-cancer-avopef-02b7a40d
nct id: NCT05551117
trial label: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0000
source section id
NCT05551117-om-0000
source outcome index
0
endpoint
Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator
endpoint definition
The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.
time origin
Assessed every 8 weeks for six months. Six month data reported.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants according to the study treatment assigned (Intent to Treat Population) for participants with mCRPC in Part 1 only. This outcome measure applies to Part 1 only. Per protocol, participants in Part 2 did not have mCRPC and were not part of this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0001
source section id
NCT05551117-om-0001
source outcome index
1
endpoint
Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria
endpoint definition
The ORR is defined as the percentage of participants in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST version 1.1 criterial CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
time origin
Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least one dose of study treatment and had RECIST-evaluable disease per RECIST v1.1 (Tumor Response Evaluable Population) in Part 2 of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0002
source section id
NCT05551117-om-0002
source outcome index
2
endpoint
Part 1: ORR Per PCWG3 Criteria as Determined by the Investigator
endpoint definition
To qualify as an objective response, CR and PR require confirmation at least 4 weeks after initial observation of complete response (CR) or partial response (PR). CR + PR = ORR
time origin
Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months,
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis is limited to only participants with mCRPC who experienced a complete or partial response to study treatment. None of the participants in the control arm experienced a complete or partial response to study treatment. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0003
source section id
NCT05551117-om-0003
source outcome index
3
endpoint
Part 1: Median Duration of Response (DoR) Per PCWG3 Criteria as Determined by the Investigator
endpoint definition
The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
time origin
Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with mCRPC who achieved a confirmed complete or partial response to study treatment. No participants in the control group had a complete or partial response. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0004
source section id
NCT05551117-om-0004
source outcome index
4
endpoint
Part 1: Mean Best Tumor Size Change Over Time
endpoint definition
Part 1: Mean Best Tumor Size Change Over Time
time origin
Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants with mCRPC who received at least one dose of study treatment and had RECIST-evaluable disease per PCWG3 (Tumor Response Evaluable Population) in Part 1 of the study. Participants in Part 2 of the study did not have mCRPC and are excluded from this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0005
source section id
NCT05551117-om-0005
source outcome index
5
endpoint
Part 1: Prostate-specific Cancer Antigen (PSA) Response Rate Per PCWG3 Criteria
endpoint definition
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
time origin
Every 4 weeks throughout study participation. Average duration 10 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants in Part 1 who received at least one dose of study treatment, with a baseline PSA ≥ 2 ng/mL and at least one post-baseline PSA measurement (PSA Response Evaluable Population). There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0000
arm key
OG000
arm label
Part 1: MGC018 2.0 mg (Arm A)
regimen
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
analyzed count
91
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0000
arm key
OG001
arm label
Part 1: MGC018 2.7 mg (Arm B)
regimen
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0000
arm key
OG002
arm label
Part 1: Control Arm
regimen
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0000
arm key
OG003
arm label
Part 2
regimen
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0001
arm key
OG000
arm label
Part 2
regimen
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0002
arm key
OG000
arm label
Part 1: MGC018 2.0 mg (Arm A)
regimen
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0002
arm key
OG001
arm label
Part 1: MGC018 2.7 mg (Arm B)
regimen
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
analyzed count
49
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0002
arm key
OG002
arm label
Part 1: Control Arm
regimen
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0002
arm key
OG003
arm label
Part 2
regimen
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0003
arm key
OG000
arm label
Part 1: MGC018 2.0 mg (Arm A)
regimen
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0003
arm key
OG001
arm label
Part 1: MGC018 2.7 mg (Arm B)
regimen
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
outcome key
om-0003
arm key
OG002
arm label
Part 1: Control Arm
regimen
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05551117-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
harm key
EG000
source section id
NCT05551117-ae
event group key
EG000
event group label
Part 1: MGC018 2.0 mg (Arm A)
serious affected
36
serious at risk
90
other affected
89
other at risk
90
frequency threshold
5
collection period
Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
event definition
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
harm key
EG001
source section id
NCT05551117-ae
event group key
EG001
event group label
Part 1: MGC018 2.7 mg (Arm B)
serious affected
44
serious at risk
86
other affected
86
other at risk
86
frequency threshold
5
collection period
Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
event definition
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
harm key
EG002
source section id
NCT05551117-ae
event group key
EG002
event group label
Part 1: Control Arm
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
event definition
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer-avopef-02b7a40d
nct id
NCT05551117
harm key
EG003
source section id
NCT05551117-ae
event group key
EG003
event group label
Part 2
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
event definition
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice