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Ovarian CancerPhase 1NCT04406623

Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer

A Phase 1 study testing SL-172154 in people with Ovarian Cancer and Fallopian Tube Cancer, run by Shattuck Labs, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
SL-172154
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
6 sitesUnited States
Study dates
29 Jun 2020to 2 Feb 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • City of Hope

    Duarte, California, 91016

  • START Midwest

    Grand Rapids, Michigan, 49546

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Stephenson Cancer Center at Oklahoma University

    Oklahoma City, Oklahoma, 73104

  • START Mountain Region

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
SL-172154
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SL-172154Drug

    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.

Study groups in NCT04406623
Study groupRoleWhat they receive
SL-172154ExperimentalIntravenous administration
Receives: Drug: SL-172154

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Profile of SL-172154

    Number of participants with treatment emergent adverse events

    Measured: From Day 1 to 90 days after Last Dose of SL-172154

  2. Maximum Tolerated Dose (MTD) of SL-172154

    Number of participants with dose limiting toxicities (DLTs)

    Measured: From Day 1 to 90 days after Last Dose of SL-172154

Secondary outcomes (10)

  1. Recommended Phase 2 Dose (RP2D) for SL-172154

    Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects

    Measured: Approximately 24 months

  2. Assess Preliminary Evidence of Anti-tumor Activity of SL-172154

    Number of participants with an objective response per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Objective response includes complete response (disappearance of all target lesions) and partial response (>/= 30% decrease in the sum of the longest diameter of target lesions).

    Measured: Approximately 24 months

  3. Immunogenicity to SL-172154

    Number of participants with positive anti-drug antibody (ADA) titer, sustained ADA response (positive ADA in >/= 2 samples without reverting to negative ADA or positive ADA in the last sample), or persistent ADA response (positive ADA in >/= 2 samples where the first and last samples are >/= 16 weeks apart, or positive ADA in the last sample, or only one sample but < 16 weeks before a negative last sample).

    Measured: Approximately 24 months

  4. Maximum Serum Concentration (Cmax) of SL-172154

    The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

  5. Minimum Serum Concentration (Cmin) of SL-172154

    The Cmin is the minimum observed serum concentration of SL-172154 following at least one dose

    Measured: Cycle 1 Day 15 and Cycle 2 Day 1 (each cycle = 28 days)

  6. Time at Which Maximum Concentration of SL-172154 is Observed (Tmax)

    The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

  7. Area Under the Serum Concentration-time Curve (AUC)

    The AUC is the area under the serum concentration time curve following single and multiple doses of SL-172154. AUC (0-last; from time 0 to the last quantifiable concentration) is reported for C1D1 and AUC (tau; over a dosing interval) is reported for C1D15 and C2D1.

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

  8. Terminal Elimination Half-life (t1/2)

    Terminal elimination half-life (t1/2) of SL-172154

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

  9. Clearance (CL)

    Clearance of SL-172154

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

  10. Volume of Distribution

    Volume of distribution of SL-172154

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study start29 Jun 2020
  3. Primary completion2 Feb 2023
  4. Study completion2 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04406623
Sponsor's protocol ID
SL03-OHD-101
Status last verified
Jan 2025
First submitted
19 May 2020
Last updated
30 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lakhani NJ, Stewart D, Richardson DL, Dockery LE, Van Le L, Call J, Rangwala F, Wang G, Ma B, Metenou S, Huguet J, Offman E, Pandite L, Hamilton E. First-in-human phase I trial of the bispecific CD47 inhibitor and CD40 agonist Fc-fusion protein, SL-172154 in patients with platinum-resistant ovarian cancer. J Immunother Cancer. 2025 Jan 11;13(1):e010565. doi: 10.1136/jitc-2024-010565.

    PubMed 39800375

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SL-172154 in people with Ovarian Cancer and Fallopian Tube Cancer, run by Shattuck Labs, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Profile of SL-172154 (time frame: From Day 1 to 90 days after Last Dose of SL-172154). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04406623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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