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Platinum-resistant Ovarian CancerPhase 1NCT05483933

Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers

A Phase 1 study testing Pegylated Liposomal Doxorubicin + SL-172154 and Mirvetuximab + SL-172154 in people with Platinum-resistant Ovarian Cancer and Fallopian Tube Cancer, run by Shattuck Labs, Inc. at 21 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pegylated Liposomal Doxorubicin + SL-172154 and Mirvetuximab + SL-172154
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
21 sitesin 4 countries
Study dates
18 Aug 2022to 7 Feb 2025
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

  • 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.
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  • [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

Who cannot join

  • 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.
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  • 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]

Trial locations and contacts

21 sites in 4 countries.

21 sites in 4 countries

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona Servicio de Oncología, Esc. 2, Planta 5 dcha

    Barcelona, Catalonia, 08036

  • Hospital Universitario Quirón-Dexeus Servicio de Oncologia Médica

    Barcelona, 08028

  • Hospital Universitario Dr. Josep Trueta - ICO de Girona, Servicio de Oncología Av. Francia s/n

    Girona, 17007

  • Hospital Universitari Vall D Hebron

    Madrid, 28013

  • Hospital Universitario Fundacion Jimenez Diaz START Madrid-FJD- Unidad de Ensayos Fase I

    Madrid, 28040

  • Hospital Universitario Virgen de la Arrixaca. Servicio de Oncología Ctra. Madrid-Cartagena, s/n

    Murcia, 30120

Other trials in Spain

United Kingdom6 sites

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • University College London Hospitals NHS Foundation Trust

    London, W1T 7HA

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, Lancashire, PR2 9HT

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

United States5 sites

  • Robert H.Lurie ComprehensiveCancer Center, Northwestern University

    Chicago, Illinois, 60611

  • City of Hope

    Duarte, California, 91010

  • START Midwest

    Grand Rapids, Michigan, 49546

  • University of Arkansas for Medical sciences

    Little Rock, Arkansas, 72205

  • Stephenson Cancer Center, OU Health/ Sarah Cannon Research Institute

    Oklahoma City, Oklahoma, 73104

Other trials in United States

Canada3 sites

  • McGill University Health Care

    Montreal, Quebec, H4A 3J1

  • University health Network (UHN)-University of Toronto

    Toronto, Ontario, M5G 2M9

  • BC Cancer Center

    Vancouver, British Columbia, BC V5Z 4E6

Other trials in Canada

About this study

Official title: 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

SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study.

Read the 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.

Being tested
Pegylated Liposomal Doxorubicin + SL-172154, Mirvetuximab + SL-172154
Keywords
Platinum-resistant, Ovarian, Peritoneal, High grade serous EOC, primary peritoneal cancer, Fallopian, Combination, Mirvetuximab Soravtansine, SL-172154, SIRPα-Fc-CD40L, Pegylated Liposomal Doxorubicin
Medical subject headings
Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

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

  • Pegylated Liposomal Doxorubicin + SL-172154Drug

    Also called Doxil, PLD, Caelyx

    The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.

  • Mirvetuximab + SL-172154Drug

    Also called IMGN853, MIRV

    The investigational product, SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.

Study groups in NCT05483933
Study groupRoleWhat they receive
Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)ExperimentalPegylated Liposomal Doxorubicin (PLD) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration.
Receives: Drug: Pegylated Liposomal Doxorubicin + SL-172154
Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)ExperimentalMirvetuximab (MIRV) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration
Receives: Drug: Mirvetuximab + SL-172154

What is being measured

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

  1. Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab

    Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts

    Measured: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months

  2. Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab

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

    Measured: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months

Secondary outcomes (9)

  1. To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab

    Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)

    Measured: approximately 24 months

  2. Immunogenicity to SL-172154

    Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline

    Measured: approximately 24 months

  3. Immunogenicity to MIRV

    Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline

    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: C1D8, C1D15, C2D8

  5. Area Under the Serum Concentration-time Curve (AUC) of SL-172154

    The AUC is the area under the serum concentration time curve of SL-172154 following single and multiple doses

    Measured: C1D8, C1D15 and C2D8

  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: C1D8, C1D15 and C2D8

  7. Maximum Serum Concentration (Cmax) of MIRV

    The Cmax is the maximum observed serum concentration of MIRV following single and multiple doses

    Measured: Day 1 of each cycle, pre-dose and end of infusion (EOI)

  8. Maximum Serum Concentration (Cmax) of Total Antibody (MIRV)

    The Cmax is the maximum observed serum concentration of Total Antibody (MIRV) following single and multiple doses

    Measured: Day 1 of each cycle, pre-dose and end of infusion (EOI)

  9. Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV)

    The Cmax is the maximum observed serum concentration of DM4 Payload and S-Methyl DM4 payload following single and multiple doses

    Measured: Day 1 of each cycle, pre-dose and end of infusion (EOI)

Timeline

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

  1. First posted2 Aug 2022
  2. Study start18 Aug 2022
  3. Primary completion7 Feb 2025
  4. Study completion7 Feb 2025

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05483933
Sponsor's protocol ID
SL03-OHD-105
Status last verified
Dec 2025
First submitted
26 Jul 2022
Last updated
23 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Drew Y, Gilbert L, Martinez Bueno A, Oaknin A, Moreno V, Gaba Garcia L, Jayson GC, Kristeleit RS, Lakhani N, Banerjee S, Matei D, Oza A, Miller R, Yiannakis D, Barretina-Ginesta MP, Martinez Garcia J, Wang G, Miriyala J, Franke A, Galvez E, Pandite L, Richardson DL. Phase Ib trial of SL-172154, a bispecific CD47 inhibitor and CD40 agonist Fc-fusion protein, in combination with mirvetuximab soravtansine or pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. Br J Cancer. 2026 Jun;134(12):1754-1763. doi: 10.1038/s41416-026-03430-0. Epub 2026 Apr 8.

    PubMed 41951722

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pegylated Liposomal Doxorubicin + SL-172154 and Mirvetuximab + SL-172154 in people with Platinum-resistant Ovarian Cancer and Fallopian Tube Cancer, run by Shattuck Labs, Inc. at 21 sites in 4 countries.

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 18 inclusion and 20 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain, United Kingdom, United States, Canada. 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 23 Dec 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?

Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab (time frame: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months). 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 NCT05483933, 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 23 Dec 2025.

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