- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05483933
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
An Open-Label, Phase 1b Study of SL-172154 (SIRPα-Fc-CD40L) Administered With Either Pegylated Liposomal Doxorubicin or Mirvetuximab Soravtansine in Subjects With Platinum-Resistant Ovarian Cancers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with either PLD or MIRV in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers. Patients will be appropriate for combination therapy for their next line of therapy. For the SL-172154 + MIRV cohort, patients' tumors must be positive (defined as PS2+ ≥ 25%) for folate receptor alpha (FRα) as defined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay.
The first portion of the study will evaluate the safety of increasing dose levels of SL-172154 in combination with either PLD or MIRV and establish a combination dose for both regimens to be further evaluated in two dose expansion cohorts. The study will consist of a 21-day screening period, a study treatment period until at least one of the study treatment discontinuation criteria is met, and a study follow-up period.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Shattuck Clinical Trials
- Phone Number: 919-864-2700
- Email: clinicaltrials@shattucklabs.com
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, BC V5Z 4E6
- BC Cancer Center
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University health Network (UHN)-University of Toronto
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Quebec
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Montréal, Quebec, Canada, H4A 3J1
- McGill University Health Care
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Barcelona, Spain, 08028
- Hospital Universitario Quirón-Dexeus Servicio de Oncologia Médica
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Girona, Spain, 17007
- Hospital Universitario Dr. Josep Trueta - ICO de Girona, Servicio de Oncología Av. Francia s/n
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Madrid, Spain, 28013
- Hospital Universitari Vall d Hebron
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Madrid, Spain, 28040
- Hospital Universitario Fundacion Jimenez Diaz START Madrid-FJD- Unidad de Ensayos Fase I
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Murcia, Spain, 30120
- Hospital Universitario Virgen de la Arrixaca. Servicio de Oncología Ctra. Madrid-Cartagena, s/n
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitari Germans Trias I Pujol
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Catalunya
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Barcelona, Catalunya, Spain, 08036
- Hospital Clinic de Barcelona Servicio de Oncología, Esc. 2, Planta 5 dcha
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Madrid
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Pozuelo de Alarcon, Madrid, Spain, 28223
- Hospital Quirónsalud Madrid C/ Diego de Velázquez, 1. Unidad Fases I Next Oncology
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Manchester, United Kingdom, M20 4BX
- The Christie NHS Foundation Trust
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Lancashire
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Preston, Lancashire, United Kingdom, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust
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London, City Of
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London, London, City Of, United Kingdom, SE1 7EH
- Guy's & St Thomas' NHS Foundation Trust
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London, London, City Of, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust
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London, London, City Of, United Kingdom, W1T 7HA
- University College London Hospitals NHS Foundation Trust
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Sutton, London, City Of, United Kingdom, SM2 5PT
- The Royal Marsden NHS Foundation Trust
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Duarte, California, United States, 91010
- City of Hope
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H.Lurie ComprehensiveCancer Center, Northwestern University
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Michigan
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Grand Rapids, Michigan, United States, 49546
- START Midwest
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Ohio
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Columbus, Ohio, United States, 43214
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center, OU Health/ Sarah Cannon Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
- Age ≥18 years
- [PLD Cohort] Subject has a histologically confirmed diagnosis of high grade epithelial ovarian cancer, including primary peritoneal cancer or fallopian tube cancer. Non-epithelial tumors and ovarian tumors with low malignant potential are excluded.
- [PLD Cohort] Subject must have platinum-resistant disease, defined as radiologic disease progression within 180 days (6 months) following the last administered dose of platinum therapy. Subjects who are primary platinum-refractory, defined by progressing during or within 1 month of upfront platinum therapy, are excluded.
- [PLD Cohort] Subjects may have received any number of prior lines of therapy for epithelial ovarian cancer; however, they may not have received more than 1 prior line of systemic anticancer therapy for platinum-resistant disease.
- [MIRV Cohort] Subject has a histologically confirmed diagnosis of high grade serous epithelial ovarian cancer, including primary peritoneal cancer or fallopian tube cancer. Non-epithelial tumors and ovarian tumors with low malignant potential are excluded.
[MIRV Cohort] Subject must have platinum-resistant disease as defined by:
- Subjects who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (complete response/remission [CR] or partial response/remission [PR]) and then progressed between >3 months and ≤6 months after the date of the last dose of platinum.
- Subjects who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum.
- Subjects who are platinum refractory during front-line treatment are excluded [primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy]
- [MIRV Cohort] Subjects must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy.
- [MIRV Cohort] Willing to provide an archival tumor tissue block or slides or undergo procedure to obtain new biopsy using a low-risk, medically routine procedure for IHC confirmation of FRα positivity.
- [MIRV Cohort] Subject's tumor must be positive for FRα expression (defined as PS2+ ≥ 25% by the Ventana FOLR1 Assay).
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Measurable disease by RECIST v1.1 using radiologic assessment.
- Adequate organ and hematologic function
- Subjects must have stabilized or recovered (Grade 1 or baseline) from all prior anti-cancer therapy-related toxicities.
- [MIRV Cohort, Dose Expansion only] Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy, unless there is excessive risk from the procedure as determined by the investigator
Exclusion Criteria:
- Prior treatment with a signal-regulatory protein alpha (SIRPα) targeting agent, anti-CD47 agent or CD40 agonist.
- [PLD Cohort] Prior treatment with doxorubicin or PLD
- [MIRV Cohort] Prior treatment with MIRV or another FRα-targeting agent
- Any anti-cancer therapy within the time intervals specified per protocol.
- Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment is prohibited.
- Receipt of live attenuated vaccine (including live attenuated vaccines for COVID-19) within 28 days of the first dose of study treatment.
- Current or prior use of systemic immunosuppressive medication within 7 days prior to first dose of study treatment.
- [MIRV Cohort] Requires use of folate-containing supplements (e.g., folate deficiency)
- Active or documented history of autoimmune disease that has required treatment with a disease modifying agent or immunosuppressive therapy in the past two years, history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome). Exceptions include controlled Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism.
- Ongoing or active infection (e.g., no systemic antimicrobial therapy for treatment of infection within 5 days of D1 of study treatment).
- Known severe hypersensitivity to the active drug substance or to any of the excipients for the agents to be administered or known hypersensitivity to Chinese hamster ovary cell products.
- Severe gastrointestinal conditions.
- Clinically significant or uncontrolled cardiovascular disease
- [MIRV Cohort] History of cirrhotic liver disease (Child-Pugh Class B or C)
- [MIRV Cohort] Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision.
- Previous clinical diagnosis of noninfectious interstitial lung disease (ILD), including noninfectious pneumonia.
- Untreated central nervous system or leptomeningeal metastases.
- Another malignancy that requires active therapy and that, in the opinion of the investigator and Sponsor, would interfere with monitoring of radiologic assessments of response to the study treatment.
- Has undergone allogeneic stem cell transplantation or organ transplantation.
- Known history or positive test for human immunodeficiency virus (HIV), or positive test for hepatitis B (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)
Pegylated Liposomal Doxorubicin (PLD) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration.
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The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
Other Names:
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Experimental: Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)
Mirvetuximab (MIRV) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration
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The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evaluate safety and tolerability of SL-172154 when administered with PLD
Time Frame: first dose up to 3 years
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Incidence and severity of adverse events (AE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0
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first dose up to 3 years
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Evaluate safety and tolerability of SL-172154 when administered with MIRV
Time Frame: first dose up to 3 years
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Incidence and severity of adverse events (AE) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0
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first dose up to 3 years
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Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with PLD
Time Frame: first dose up to 1 year
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Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with PLD for the dose expansion phase
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first dose up to 1 year
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Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with MIRV
Time Frame: first dose up to 1 year
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Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with MIRV for the dose expansion phase
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first dose up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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To assess preliminary evidence of anti-tumor activity of SL-172154 when administered with PLD
Time Frame: first dose up to 3 years
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Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
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first dose up to 3 years
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To assess preliminary evidence of anti-tumor activity of SL-172154 when administered with MIRV
Time Frame: first dose up to 3 years
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Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
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first dose up to 3 years
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Immunogenicity to SL-172154
Time Frame: first dose up to 3 years
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Number and proportion of participants with positive anti-drug antibody titer
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first dose up to 3 years
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Immunogenicity to MIRV
Time Frame: first dose up to 3 years
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Number and proportion of participants with positive anti-drug antibody titer
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first dose up to 3 years
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Maximum serum concentration (Cmax) of SL-172154
Time Frame: first dose up to 3 years
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The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses
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first dose up to 3 years
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Maximum serum concentration (Cmax) of MIRV
Time Frame: first dose up to 3 years
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The Cmax is the maximum observed serum concentration of MIRV following single and multiple doses
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first dose up to 3 years
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Maximum serum concentration (Cmax) of Total Antibody
Time Frame: first dose up to 3 years
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The Cmax is the maximum observed serum concentration of Total Antibody following single and multiple doses
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first dose up to 3 years
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Maximum serum concentration (Cmax) of DM4 Payload
Time Frame: first dose up to 3 years
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The Cmax is the maximum observed serum concentration of DM4 Payload following single and multiple doses
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first dose up to 3 years
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Maximum serum concentration (Cmax) of S-Methyl DM4 Payload
Time Frame: first dose up to 3 years
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The Cmax is the maximum observed serum concentration of S-Methyl DM4 Payload following single and multiple doses
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first dose up to 3 years
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Area under the serum concentration-time curve (AUC) of SL-172154
Time Frame: first dose up to 3 years
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The AUC is the area under the serum concentration time curve of SL-172154 following single and multiple doses
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first dose up to 3 years
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Area under the serum concentration-time curve (AUC) of MIRV
Time Frame: first dose up to 3 years
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The AUC is the area under the serum concentration time curve of MIRV following single and multiple doses
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first dose up to 3 years
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Area under the serum concentration-time curve (AUC) of Total Antibody
Time Frame: first dose up to 3 years
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The AUC is the area under the serum concentration time curve of Total Antibody following single and multiple doses
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first dose up to 3 years
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Area under the serum concentration-time curve (AUC) of DM4 Payload
Time Frame: first dose up to 3 years
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The AUC is the area under the serum concentration time curve of DM4 Payload following single and multiple doses
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first dose up to 3 years
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Area under the serum concentration-time curve (AUC) of S-Methyl DM4 Payload
Time Frame: first dose up to 3 years
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The AUC is the area under the serum concentration time curve of S-Methyl DM4 Payload following single and multiple doses
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first dose up to 3 years
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Terminal elimination half-life (t1/2) of SL-172154
Time Frame: first dose up to 3 years
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Terminal elimination half-life (t1/2) of SL-172154
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first dose up to 3 years
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Terminal elimination half-life (t1/2) of MIRV
Time Frame: first dose up to 3 years
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Terminal elimination half-life (t1/2) of MIRV
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first dose up to 3 years
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Terminal elimination half-life (t1/2) of Total Antibody
Time Frame: first dose up to 3 years
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Terminal elimination half-life (t1/2) of Total Antibody
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first dose up to 3 years
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Terminal elimination half-life (t1/2) of DM4 Payload
Time Frame: first dose up to 3 years
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Terminal elimination half-life (t1/2) of DM4 Payload
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first dose up to 3 years
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Terminal elimination half-life (t1/2) of S-Methyl DM4 Payload
Time Frame: first dose up to 3 years
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Terminal elimination half-life (t1/2) of S-Methyl DM4 Payload
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first dose up to 3 years
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shattuck Labs, Shattuck Labs
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- SL03-OHD-105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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