Neoplasms

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Nevus

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Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Small Cell Lung Cancer

Oral Squamous Cell Carcinoma

Anal Cancer

Neuroendocrine Tumor

Neuroepithelioma

vobramitamab duocarmazine 2.0 mg (Arm A)

vobramitamab duocarmazine 2.7 mg (Arm B)

vobramitamab duocarmazine

Ashley Ward, M.D.

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 squamous cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC). Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab docarmazine 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 for up to 26 cycles, approximately 2 years, 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.

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

A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

The rPFS is defined as the time from the date of randomization to the date of first documented progressive disease (PD) per Prostate Cancer Working Group 3 (PCWG3) or death from any cause, whichever occurs first. Three arms will be compared: Arm A, Arm B, and control.

The ORR is defined as the percentage of participants in the response evaluable poplaiton who achieve a best overall response of conplete 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.

The number of participants experiencing a complete response (CR) or partial response (PR) to treatment.

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.

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%.

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.

Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.

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.

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

PFS is defined as the time from the date of the first dose to the date of first PD per RECIST 1.1 criteria or death from any cause, whichever occurs first.

MacroGenics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors	NCT05551117	Castration-Resi... Androgen-Indepe... Androgen-Insens... Androgen-Resist... Hormone Refract... Anal Cancer Anal Neoplasm Carcinoma, Squa... Head and Neck S... Laryngeal Squam... Oral Squamous C... Malignant Melan... Melanoma Non-small Cell ... Non-small Cell ... Small-cell Lung... Small Cell Carc...	vobramitamab du... vobramitamab du... vobramitamab du...	18 Years -	MacroGenics
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors	NCT05551117	Castration-Resi... Androgen-Indepe... Androgen-Insens... Androgen-Resist... Hormone Refract... Anal Cancer Anal Neoplasm Carcinoma, Squa... Head and Neck S... Laryngeal Squam... Oral Squamous C... Malignant Melan... Melanoma Non-small Cell ... Non-small Cell ... Small-cell Lung... Small Cell Carc...	vobramitamab du... vobramitamab du... vobramitamab du...	18 Years -	MacroGenics

Spots Global Cancer Trial Database for vobramitamab duocarmazine 2.0 mg (arm a)