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

NCT05483933 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SL03-OHD-105
• Study Type: interventional
• Target: 86
• Locations: 4 countries
• Sites: 21

Brief 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.

Conditions

Platinum-resistant Ovarian Cancer; Fallopian Tube Cancer; Epithelial Ovarian Cancer; Ovarian Cancer; Primary Peritoneal Carcinoma; Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma

Keywords

Platinum-resistant; Ovarian; Peritoneal; High grade serous EOC; primary peritoneal cancer; Fallopian; Combination; Mirvetuximab Soravtansine; SL-172154; SIRPα-Fc-CD40L; Pegylated Liposomal Doxorubicin

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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"

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

Secondary Outcomes (9)

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

  approximately 24 months

• Immunogenicity to SL-172154

  approximately 24 months

• Immunogenicity to MIRV

  approximately 24 months

• Maximum Serum Concentration (Cmax) of SL-172154

  C1D8, C1D15, C2D8

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

  C1D8, C1D15 and C2D8

Study Arms (2)

Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)

EXPERIMENTAL

Pegylated Liposomal Doxorubicin (PLD) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration.

Drug: Pegylated Liposomal Doxorubicin + SL-172154

Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)

EXPERIMENTAL

Mirvetuximab (MIRV) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration

Drug: Mirvetuximab + SL-172154

Interventions

Pegylated Liposomal Doxorubicin + SL-172154 DRUG

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

Also known as: Doxil, PLD, Caelyx

Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)

Mirvetuximab + SL-172154 DRUG

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

Also known as: IMGN853, MIRV

Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shattuck Labs, Inc.: lead

Study Sites (21)

University of Arkansas for Medical sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Robert H.Lurie ComprehensiveCancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Stephenson Cancer Center, OU Health/ Sarah Cannon Research Institute

Oklahoma City, Oklahoma, 73104, United States

Location

BC Cancer Center

Vancouver, British Columbia, BC V5Z 4E6, Canada

Location

University health Network (UHN)-University of Toronto

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Care

Montreal, Quebec, H4A 3J1, Canada

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

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

Barcelona, Catalonia, 08036, Spain

Location

Hospital Universitario Quirón-Dexeus Servicio de Oncologia Médica

Barcelona, 08028, Spain

Location

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

Girona, 17007, Spain

Location

Hospital Universitari Vall D Hebron

Madrid, 28013, Spain

Location

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

Madrid, 28040, Spain

Location

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

Murcia, 30120, Spain

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, W1T 7HA, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

liposomal doxorubicin; 1-dodecylpyridoxal; mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: Shattuck Labs

clinicaltrials@shattucklabs.com

919-864-2700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 2, 2022
• Study Start: August 18, 2022
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

GB (6); CA (3); US (5); ES (7)