- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406623
Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer
May 16, 2023 updated by: Shattuck Labs, Inc.
Phase 1 Dose Escalation Study of the Agonist Redirected Checkpoint, SL-172154 (SIRPα-Fc-CD40L) Administered Intravenously in Subjects With Ovarian Cancer
This is a Phase 1 first in human, open label, multi-center, dose escalation study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-172154 in subjects with ovarian cancer.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor and pharmacodynamic effects of SL-172154 and identify the dose and schedule i.e., recommended Phase 2 dose for future development (RP2D).
Subjects eligible for enrollment are required to have platinum-ineligible ovarian, fallopian tube, and primary peritoneal cancers.
The study design consists of dose escalation cohorts, an optional pharmacodynamic cohort, and an optional dose expansion cohort.
In the dose escalation phase of the study, subjects will be enrolled into sequential dose levels.
The study may also enroll a pharmacodynamic cohort to obtain additional pharmacodynamic data at one or more dose levels that have completed evaluation for safety without exceeding the maximum tolerated dose (MTD).
Subjects enrolled in the pharmacodynamic cohort will not inform dose escalation decisions.
A dose expansion cohort may be opened to further characterize safety, tolerability, PK, anti-tumor activity, and pharmacodynamic data to inform the selection of a RP2D.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Duarte, California, United States, 91016
- City of Hope
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49546
- START Midwest
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center at Oklahoma University
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
-
-
Utah
-
West Valley City, Utah, United States, 84119
- START Mountain Region
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
- Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
- Subject must have a histologically confirmed diagnosis of an unresectable, locally advanced or metastatic ovarian cancer, or primary peritoneal cancer or fallopian tube cancer.
- Subjects must be refractory or intolerant to existing therapy(ies) known to provide clinical benefit for their condition. Subject must have received platinum-based therapies, and should not be eligible for further platinum therapy, or should be intolerant to such therapy. Subjects with HRD positive disease may participate if they have received prior polyadenosine diphosphate ribose polymerase (PARP) inhibitor therapy given alone or with bevacizumab.
- Subjects should not be primary platinum refractory as defined by progressing during or within 1 month of upfront platinum therapy.
- Has measurable disease by RECIST v1.1 using radiologic assessment.
- Subject age is 18 years and older.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Has life expectancy of greater than 12 weeks.
- Has adequate organ function.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of D1 of IP.
- Recovery from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or ≤ Grade 1.
- Willing to consent to mandatory pre-treatment and on-treatment tumor biopsy(ies), unless there is excessive risk as determined by the investigator.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Prior treatment with an anti-CD47 or anti-SIRPα targeting agent or a CD40 agonist.
- Any anti-cancer therapy within the washout period prior to first dose (D1) of SL-172154.
- Concurrent chemotherapy, immunotherapy, biologic or hormonal/hormonal suppression therapy for cancer treatment is prohibited. Concurrent use of hormones for non-cancer related conditions is acceptable.
- Use of corticosteroids or other immunosuppressive medication, current or within 14 days of D1 of SL-172154 treatment.
- Receipt of live attenuated vaccine within 28 days of D1 of IP.
- Active or documented history of autoimmune disease. Exceptions include controlled Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism.
- Hypersensitivity to the active drug substance or to any of the excipients for the agent to be administered or subjects with known hypersensitivity to Chinese hamster ovary cell products.
- Active pneumonitis (i.e. drug-induced, idiopathic pulmonary fibrosis, radiation-induced, etc.).
- Ongoing or active infection (e.g., no systemic antimicrobial therapy for treatment of infection within 5 days of D1 of IP).
- Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal disease associated with diarrhea within 6 months of D1 of IP.
- Clinically significant or uncontrolled cardiac/thromboembolic disease.
- Untreated central nervous system or leptomeningeal metastases.
- Women who are breast feeding.
- Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or compromised ability to provide written informed consent.
- 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 IP.
- Has undergone allogeneic stem cell transplantation or organ transplantation.
- Known history or positive test for human immunodeficiency virus, or positive test for hepatitis B.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SL-172154
Intravenous administration
|
The investigational product (IP), SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety profile of SL-172154
Time Frame: From Day 1 to 90 days after Last Dose of SL-172154
|
Incidence of all treatment emergent adverse events
|
From Day 1 to 90 days after Last Dose of SL-172154
|
Maximum Tolerated Dose (MTD) of SL-172154
Time Frame: From Day 1 to 90 days after Last Dose of SL-172154
|
Defined based on the rate of dose limiting toxicities (DLTs)
|
From Day 1 to 90 days after Last Dose of SL-172154
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time at which maximum concentration of SL-172154 is observed (Tmax)
Time Frame: Approximately 24 months
|
The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses
|
Approximately 24 months
|
Area under the serum concentration-time curve (AUC)
Time Frame: Approximately 24 months
|
The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154
|
Approximately 24 months
|
Terminal elimination half-life (t1/2)
Time Frame: Approximately 24 months
|
Terminal elimination half-life (t1/2) of SL-172154
|
Approximately 24 months
|
Clearance (CL)
Time Frame: Approximately 24 months
|
Clearance of Sl-172154
|
Approximately 24 months
|
Volume of distribution
Time Frame: Approximately 24 months
|
Volume of distribution of SL-172154
|
Approximately 24 months
|
Establish the recommended Phase 2 dose (RP2D) for SL-172154
Time Frame: Approximately 24 months
|
Establish the RP2D for SL-172154
|
Approximately 24 months
|
Assess preliminary evidence of anti-tumor activity of SL-172154
Time Frame: Approximately 24 months
|
Disease assessment per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
|
Approximately 24 months
|
Immunogenicity to SL-172154
Time Frame: Approximately 24 months
|
Number and proportion of participants with positive anti-drug antibody titer
|
Approximately 24 months
|
Maximum serum concentration (Cmax) of SL-172154
Time Frame: Approximately 24 months
|
The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses
|
Approximately 24 months
|
Minimum serum concentration (Cmin) of SL-172154
Time Frame: Approximately 24 months
|
The Cmin is the minimum observed serum concentration of SL-172154 following single and multiple doses
|
Approximately 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2020
Primary Completion (Actual)
February 2, 2023
Study Completion (Actual)
February 2, 2023
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 22, 2020
First Posted (Actual)
May 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
May 16, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- SL03-OHD-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Ovarian Cancer
-
Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
-
Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
University of WashingtonMinnesota Ovarian Cancer AllianceTerminatedStage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IVA Ovarian Cancer AJCC v8 | Stage IVB Ovarian... and other conditionsUnited States
Clinical Trials on SL-172154
-
Shattuck Labs, Inc.TerminatedSquamous Cell Carcinoma of Head and Neck | Cutaneous Squamous Cell CarcinomaUnited States
-
Shattuck Labs, Inc.Enrolling by invitationOvarian Cancer | Fallopian Tube Cancer | Epithelial Ovarian Cancer | Platinum-resistant Ovarian Cancer | Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal CarcinomaUnited States, United Kingdom, Spain, Canada
-
Shattuck Labs, Inc.RecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesUnited States, Canada, United Kingdom
-
Topcon Medical Systems, Inc.CompletedAny Willing and Able Person for Ocular ImagingUnited States
-
Tonix Pharmaceuticals, Inc.CompletedCOVID-19 | Long COVID | Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection | Long Haul COVIDUnited States
-
Tonix Pharmaceuticals, Inc.Completed
-
Topcon Medical Systems, Inc.Completed
-
Hevert-Arzneimittel GmbH & Co. KGCompleted
-
RWTH Aachen UniversityPfizerCompletedAtrial Fibrillation | ECG | ECG Hand-held Diagnostic ToolGermany
-
Stemline Therapeutics, Inc.CompletedStudy of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors With Advanced Solid TumorsAdvanced Solid TumorUnited Kingdom