Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy

NCT07639086 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-24-21994
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.

Conditions

Prostate Cancer; Neuroendocrine Prostate Cancer (NEPC)

Keywords

Neuroendocrine Prostate Cancer; Progression; NEPC; Small Cell Prostate Cancer; Treatment-Emergent NEC Prostate Cancer; Sacituzumab Tirumotecan; TROP2; Platinum-Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the objective response rate (ORR) of sacituzumab tirumotecan in NEPC per Prostate Cancer Working Group (PCWG) modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  The percentage of patients with confirmed partial response (PR) or complete response (CR) based on RECIST 1.1 criteria where Complete Response (CR) - disappearance of all target lesions and measurable lymph nodes. Partial Response (PR) - ≥30% decrease in the sum of target lesion diameters (SLD) compared to baseline, with no new lesions or progression of non-target lesions. Stable Disease (SD) - change in SLD between -30% and +20% compared to baseline, with no new or unequivocally progressing non-target lesions. Progressive Disease (PD) - ≥20% increase in SLD compared to the smallest recorded SLD (nadir) or appearance of new lesion

  Baseline, End of treatment, up to 30 months

Secondary Outcomes (5)

• Evaluate progression free survival (PFS), in NEPC

  Baseline, End of treatment, up to 30 months

• Evaluate overall survival (OS) in NEPC treated with sacituzumab tirumotecan

  Baseline, End of treatment, up to 30 months

• Evaluate time to response (TTR) in NEPC treated with sacituzumab tirumotecan

  Baseline, end of treatment, up to 30 months

• Evaluate duration of response (DOR) in NEPC treated with sacituzumab tirumotecan

  Baseline, End of treatment, up to 30 months

• Evaluate safety and tolerability Incidence and severity of adverse events defined by The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 6 (CTCAE v6).

  Baseline, 30 days following end of treatment, up to 30 months.

Study Arms (1)

Sacituzumab Tirumotecan

EXPERIMENTAL

Sacituzumab tirumotecan 4mg/kg Intravenous infusion

Drug: Sacituzumab Tirumotecan

Interventions

Sacituzumab Tirumotecan DRUG

Sacituzumab tirumotecan will be administered by intravenous (IV) infusion on Days 1, 15, and 29 of each 42-day cycle until disease progression or criteria of disease progression met

Sacituzumab Tirumotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed diagnosis of de novo (d-NEPC) or treatment related NEPC (t-NEPC), defined by one or more of the following: histologically small cell prostate cancer or neuroendocrine differentiation by IHC, defined by positive staining by chromogranin or synaptophysin and/or additional neuroendocrine markers. Patients with t-NEPC must have history of treatment with ADT and/or an androgen receptor pathway inhibitor (ARPI) agent.
• Note: Pure small cell/NEPC or NEPC mixed with adenocarcinoma or other histologic subtype are eligible
• Patients must have progressed following at least one course (minimum of 4 cycles) of platinum-based chemotherapy (alone or in combination with etoposide or taxane). Patients who received prior taxane alone for treatment of mHSPC or mCRPC, and patients who received a checkpoint inhibitor immunotherapy alone or in combination with prior chemotherapy are eligible. Patients who received a non-ADC drug through a prior clinical trial or Tarlatamab are also eligible provided they had also received at least one course of platinum-based chemotherapy.
• Patients who have measurable metastatic disease per PCWG modified RECIST 1.1 criteria as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. Patients with radiologically positive pelvic nodal, bone or soft tissue metastatic disease, are acceptable. Progressive disease is defined per PCWG modified RECIST 1.1 criteria.
• Note: Patients who have prior prostatectomy, definitive or salvage radiation, are eligible.
• Male participant at least 18 years of age at the time of providing the informed consent.
• If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after:
• Refrains from donating sperm
• Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method (refer to Section 10.4.2), as a condom may break or leak Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.
• If capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use a penile/external condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.
• The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
• Has provided an archival tumor tissue sample collected within 12 months prior to the enrollment or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from prostate or a metastatic site, from which NEPC was diagnosed. Irradiated tissue is not acceptable. Sites should follow local guidelines regarding fresh tissue collection.
• Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.
• Adequate organ function as defined below. Specimens must be collected within 10 days before the start of study intervention. Any value of serum prostate specific antigen (PSA) is considered eligible.
• Absolute neutrophil count ≥1500/µL

You may not qualify if:

• Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
• Received prior treatment with a TROP2-targeted ADC.
• Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
• Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. ADT and/or antiandrogens/ARPI is allowed.
• Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.
• Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
• Refer to Section 6.2 for information on COVID-19 vaccines.
• Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.
• Note: A list of strong inducers/inhibitors of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor of CYP3A4.
• Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anticancer therapy is prohibited.
• Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Links

• VCU Massey Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms; Disease Progression

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Asit Paul, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Massey CTO GU Team

CONTACT

804-628-6430; masseygu@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2032
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)