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RecruitingLast updated: 4 January 2024

TMARCK: This study is comparing different treatments in people with metastatic castration-resistant prostate cancerA Phase 2/3, Randomized, Open-label, Study of MGC018 Versus Androgen Receptor Axis-targeted Therapy (Abiraterone or Enzalutamide) in Participants With Metastatic Castration-resistant Prostate Cancer

Clinical summary

Summary

This study will enrol people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received treatment with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.

Eligible participants will be randomly allocated to one of three cohorts: Experimental A, Experimental B, or the Control Arm.

In Experimental Arm A, participants will receive vobramitamab duocarmazine (MGC018) at a dose of 2.0mg/kg every 4 weeks intravenously.

In Experimental Arm B, participants will receive vobramitamab duocarmazine (MGC018) at a dose of 2.7mg/kg every 4 weeks intravenously. In the Control Arm, participants will receive ARAT (either abiraterone or enzalutamide).

Conditions

This trial is treating patients with castration-resistant prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II/III

Trial Acronym

TMARCK

More information

Trial Identifiers

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Trial sponsor

MacroGenics

Scientific Title

A Phase 2/3, Randomized, Open-label, Study of MGC018 Versus Androgen Receptor Axis-targeted Therapy (Abiraterone or Enzalutamide) in Participants With Metastatic Castration-resistant Prostate Cancer

Eligibility

Inclusion

  • Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
  • Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
  • Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
  • Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted.
  • Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
  • Acceptable physical condition and laboratory values.

Exclusion

  • Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
  • Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
  • Received >3 total prior therapies for mCRPC
  • Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
  • Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
  • Untreated, symptomatic central nervous system (CNS) metastasis.
  • Prior treatment with any B7-H3 targeted agent for cancer,
  • Contradictions to the use of corticosteroid treatment
  • Prior stem cell, tissue, or solid organ transplant.
  • Use of products that have published anti-prostate cancer activity or are known to decrease PSA.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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