NCT05551117Phase 2Terminated

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-07-04Actual

Enrollment · participants192Actual

Source updated2026-02-09Last update listed in the registry record

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Posted 2025-11-06 · 1 field changed

Main study measure wording changed

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− Before

Measure: Part 1: Radiographic Progression Free Survival (rPFS) as Determined by the Investigator Measure: Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria

+ After

Measure: Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator Measure: Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria

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Study details

Conditions studied

Castration-Resistant Prostatic Cancer; Androgen-Independent Prostatic Cancer; Androgen-Insensitive Prostatic Cancer; Androgen-Resistant Prostatic Cancer; Hormone Refractory Prostatic Cancer; Anal Cancer; Anal Neoplasm; Carcinoma, Squamous Cell of Head and Neck; Head and Neck Squamous Cell Carcinoma; Laryngeal Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma; Malignant Melanoma; Melanoma; Non-small Cell Lung Cancer; Non-small Cell Carcinoma; Small-cell Lung Cancer; Small Cell Carcinoma

Treatments or interventions studied

vobramitamab duocarmazine 2.0 mg (Arm A)BiologicalAlso known as MGC018
vobramitamab duocarmazine 2.7 mg (Arm B)BiologicalAlso known as MGC018
vobramitamab duocarmazineBiologicalAlso known as MGC018
AbirateroneDrug
EnzalutamideDrug

Primary outcomes · main study measures

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measure: Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator; description: 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.; timeFrame: Assessed every 8 weeks for six months. Six month data reported.; measure: Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria; description: 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.; timeFrame: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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