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A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants with Metastatic Castration-resistant Prostate Cancer (TAMARACK)
EU CTIS ID: 2022-501078-20-00
What this study is testing
To evaluate the efficacy of vobramitamab duocarmazine at two dose levels as measured by Radiographic Progression Free Survival (rPFS) by investigator assessment using Prostate Cancer Working Group 3 (PCWG3) criteria.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features
- 2. 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
- 3. Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
- 4. Received 1 prior ARAT for metastatic or non-metastatic, castrationsensitive or castration-resistant prostate cancer. A second ARAT regimen of < 60 days used as bridging to lutetium-177 is permitted.
- 5. Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
- 6. Acceptable physical condition and laboratory value
You likely can't join if
- 2. Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures
- 10. Received > 3 total prior therapies for mCRPC.
- 3. Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of < 60 days used as bridging for lutetium-177 is permitted.
- 5. 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 localized malignancy are eligible
- 6. Untreated, symptomatic central nervous system (CNS) metastasis
- 7. Prior treatment with any B7-H3 targeted agent for cancer
See the full eligibility criteria
- 1. Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features
- 2. 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
- 3. Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
- 4. Received 1 prior ARAT for metastatic or non-metastatic, castrationsensitive or castration-resistant prostate cancer. A second ARAT regimen of < 60 days used as bridging to lutetium-177 is permitted.
- 5. Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
- 6. Acceptable physical condition and laboratory value
- 2. Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures
- 10. Received > 3 total prior therapies for mCRPC.
- 3. Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of < 60 days used as bridging for lutetium-177 is permitted.
- 5. 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 localized malignancy are eligible
- 6. Untreated, symptomatic central nervous system (CNS) metastasis
- 7. Prior treatment with any B7-H3 targeted agent for cancer
- 8. Contraindications to the use of corticosteroid treatment
- 9. Prior stem cell, tissue, or solid organ transplant
- 1. Use of products that have published anti-prostate cancer activity or are known to decrease PSA.
- 4. Participants with a known history of BRCA mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Australia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Australia; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.