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A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
Phase 2 trial testing vobramitamab duocarmazine 2.0 mg (Arm A) in Castration-Resistant Prostatic Cancer in 192 participants. Terminated before completion.
| Lead sponsor | MacroGenics |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 192 |
| Start date | 13 June 2023 |
| Primary completion | 4 July 2024 |
| Estimated completion | 23 January 2025 |
| Sites | 63 locations across France, Italy, Belgium, United Kingdom, Poland, South Korea, Australia, United States |
MacroGenics — full company profile →
18 and older, any sex, with Castration-Resistant Prostatic Cancer or Androgen-Independent Prostatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 0.69 | 0.57 – 0.78 |
| Part 1: MGC018 2.7 mg (Arm B) | 0.70 | 0.46 – 0.79 |
| Part 1: Control Arm | 0.47 | 0.021 – NA |
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.
| Group | Value | 95% CI |
|---|---|---|
| Part 2 | 0 |
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
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 13.6 | |
| Part 1: MGC018 2.7 mg (Arm B) | 30.6 | |
| Part 1: Control Arm | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 9.4 | 3.68 – NA |
| Part 1: MGC018 2.7 mg (Arm B) | 9.1 | 5.78 – 9.92 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | -13.0 | ± 59.70 |
| Part 1: MGC018 2.7 mg (Arm B) | -29.0 | ± 33.92 |
| Part 1: Control Arm | -7.44 | ± 7.16 |
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%.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 45.8 | 34.8 – 57.1 |
| Part 1: MGC018 2.7 mg (Arm B) | 38.0 | 26.8 – 50.3 |
In participants with a decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks. Time to PSA progression is defined as the time from the date of randomization to the first PSA progression.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 5.9 | 4.63 – 6.97 |
| Part 1: MGC018 2.7 mg (Arm B) | 6.9 | 4.83 – NA |
| Part 1: Control Arm | 4.6 | NA – NA |
Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 6.1 | 4.63 – NA |
| Part 1: MGC018 2.7 mg (Arm B) | NA | 5.13 – NA |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | -28.7 | ± 67.05 |
| Part 1: MGC018 2.7 mg (Arm B) | -33.1 | ± 70.89 |
An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 3.71 | ± 1.984 |
| Part 1: MGC018 2.7 mg (Arm B) | 2.80 | ± 2.142 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 89 | |
| Part 1: MGC018 2.7 mg (Arm B) | 86 | |
| Part 1: Control Arm | 3 | |
| Part 2 | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 36 | |
| Part 1: MGC018 2.7 mg (Arm B) | 44 | |
| Part 1: Control Arm | 1 | |
| Part 2 | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 28 | |
| Part 1: MGC018 2.7 mg (Arm B) | 41 | |
| Part 1: Control Arm | 0 | |
| Part 2 | 2 |
Participant specimens were evaluated for the presence of ADA beginning a baseline and throughout the study. If at any time during the study, the results show evidence of ADA, they were counted as ADA positive. There was no time-to- event analysis nor by visit analysis of the data.
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 0 | |
| Part 1: MGC018 2.7 mg (Arm B) | 0 | |
| Part 2 | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Part 1: MGC018 2.0 mg (Arm A) | 22 | |
| Part 1: MGC018 2.7 mg (Arm B) | 16 | |
| Part 2 | 0 |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part 1: MGC018 2.0 mg (Arm… | Part 1: MGC018 2.7 mg (Arm… | Part 1: Control Arm | Part 2 |
|---|---|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| General physical health deterioration | General disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — | — |
| Angina unstable | Cardiac disorders | — | — | — | — |
| Aortic valve incompetence | Cardiac disorders | — | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — | — |
| Left ventricular dysfunction | Cardiac disorders | — | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — | — |
| Stress cardiomyopathy | Cardiac disorders | — | — | — | — |
| Supraventricular tachyarrhythmia | Cardiac disorders | — | — | — | — |
| Ventricular fibrillation | Cardiac disorders | — | — | — | — |
| Hypothalamo-pituitary disorder | Endocrine disorders | — | — | — | — |
| Reaction | System | Part 1: MGC018 2.0 mg (Arm… | Part 1: MGC018 2.7 mg (Arm… | Part 1: Control Arm | Part 2 |
|---|---|---|---|---|---|
| Asthenia | General disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Conjunctivitis | Infections and infestations | — | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — | — | — |
| Dry eye | Eye disorders | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Eyelid oedema | Eye disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
Most-reported serious reactions: Pleural effusion, Pericardial effusion, Pneumonia, Atrial fibrillation, General physical health deterioration, Dyspnoea, Pulmonary embolism, Anaemia.
Data from ClinicalTrials.gov NCT05551117 adverse events section.
Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic solid tumors. Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab duocarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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