Ovarian Cancer Clinical Trial

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

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 in two phases: dose escalation and dose expansion.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 EOC, 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 that are primary platinum-refractory, defined by progressing during or within 1 month of upfront platinum therapy, are excluded.
[PLD Cohort] Subjects must have received no more than 1 prior line of systemic anticancer therapy for platinum-resistant disease and have either received bevacizumab, be medically-ineligible for bevacizumab, or bevacizumab not indicated per local standard of care.
[MIRV Cohort] Subject has a histologically confirmed diagnosis of high grade serous EOC, 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.
Patients 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, including at least 1 line of therapy containing bevacizumab or be medically-ineligible for bevacizumab.
[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%) as defined 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 and PLD Cohorts, 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, 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 CNS 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 is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

102

Study ID:

NCT05483933

Recruitment Status:

Recruiting

Sponsor:

Shattuck Labs, Inc.

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There are 24 Locations for this study

See Locations Near You

University of Arkansas for Medical sciences
Little Rock Arkansas, 72205, United States More Info
Maroof Khan Zafar
Contact
501-686-8274
[email protected]
Michael Birrer
Principal Investigator
City of Hope
Duarte California, 91010, United States More Info
Lindsay Kilpatrick
Contact
626-471-9200
Mihae Song, MD
Principal Investigator
Robert H.Lurie ComprehensiveCancer Center, Northwestern University
Chicago Illinois, 60611, United States More Info
Jonathan Parker
Contact
312-695-4511
Daniel Matei
Principal Investigator
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Rebecca Gash
Contact
[email protected]
John T Hamm, MD
Principal Investigator
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Shannon Fabrie
Contact
616-954-5550
Nehal Lakhani, MD, PhD
Principal Investigator
Columbia University
New York New York, 10032, United States More Info
Jason Wright
Contact
212-305-3410
[email protected]
Reena Vattakalam
Contact
212-342-6895
[email protected]
June Hou
Principal Investigator
Stephenson Cancer Center, OU Health/ Sarah Cannon Research Institute
Oklahoma City Oklahoma, 73104, United States More Info
Zachary Chandler, MA
Contact
405-271-8001
Debra L Richardson, MD
Principal Investigator
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Kristina Powell
Contact
215-220-9535
[email protected]
Lainie Martin
Principal Investigator
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Lucia Borrasso
Contact
412-641-1153
[email protected]
Brieana Marino
Contact
412- 647-8258
[email protected]
Sarah Taylor
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Eris Steele
Contact
615-329-7305
Erika Hamilton, MD
Principal Investigator
BC Cancer Center
Vancouver British Columbia, BC V5, Canada More Info
Briannah Tsang
Contact
Candace Chan
Contact
Yvette Drew, MD
Principal Investigator
University health Network (UHN)-University of Toronto
Toronto Ontario, M5G 2, Canada More Info
Nora Dewart
Contact
[email protected]
Melissa Lo
Contact
416-946-4501
[email protected]
Amit Oza
Principal Investigator
McGill University Health Care
Montréal Quebec, H4A 3, Canada More Info
Nathalie Nam
Contact
[email protected]
Lucy Gilbert, MD
Principal Investigator
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain More Info
Iris Teruel Garcia
Contact
+34 934978950
[email protected]
Milana Arantza Bergamino Sirven
Principal Investigator
Hospital Clinic de Barcelona Servicio de Oncología, Esc. 2, Planta 5 dcha
Barcelona Catalunya, 08036, Spain More Info
Laura Berengué
Contact
932275400
[email protected]
Maria De Riba
Contact
932275400
[email protected]
Lydia Gaba Garcia
Principal Investigator
Hospital Quirónsalud Madrid C/ Diego de Velázquez, 1. Unidad Fases I Next Oncology
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Laura López Garcia
Contact
+34 914521900
[email protected]
Beatriz Rico García-Reyes
Contact
+34914521900
[email protected]
Valentina Boni, Dr.
Principal Investigator
Hospital Universitario Quirón-Dexeus Servicio de Oncologia Médica
Barcelona , 08028, Spain More Info
Carlos Esparré
Contact
0034 93 546 01 43
[email protected]
Alejandro Alfonso Martínez Bueno
Principal Investigator
Hospital Universitario Dr. Josep Trueta - ICO de Girona, Servicio de Oncología Av. Francia s/n
Girona , 17007, Spain More Info
Begoña Martin Castillo
Contact
+ 34972 22 58 28
[email protected]
Blanca Martinez Sanchez
Contact
0034 972 940274
[email protected]
Pilar Barretina
Principal Investigator
Hospital Universitario Fundacion Jimenez Diaz START Madrid-FJD- Unidad de Ensayos Fase I
Madrid , 28040, Spain More Info
María Encinas de Andrés
Contact
915504800
[email protected]
Sonia Pérez Pérez
Contact
915504800
[email protected]
Victor Moreno Garcia, Dr.
Principal Investigator
Hospital Universitario Virgen de la Arrixaca. Servicio de Oncología Ctra. Madrid-Cartagena, s/n
Murcia , 30120, Spain More Info
Cristina Pagán
Contact
34968369387
[email protected]
María Ángeles García Soler
Contact
[email protected]
Jerónimo Martínez García
Principal Investigator
The Royal Marsden NHS Foundation Trust
London London, City Of, SW3 6, United Kingdom More Info
Laura Pope
Contact
2089156724
[email protected]
Anna Gawryluk
Contact
0207 808 2868
[email protected]
Susana Banerjee
Principal Investigator
University College London Hospitals NHS Foundation Trust
London London, City Of, W1T 7, United Kingdom More Info
Claudia Ismail
Contact
02034472929
[email protected]
Rowan Miller
Principal Investigator
The Royal Marsden NHS Foundation Trust
Sutton London, City Of, SM2 5, United Kingdom More Info
Kylie Fitch
Contact
+442089156724
[email protected]
Darshana Shah
Contact
02089156061
[email protected]
Susana Banerjee
Principal Investigator
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom More Info
Amy Pearce
Contact
0161 918 7688
[email protected]
Jayson Gordon
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

102

Study ID:

NCT05483933

Recruitment Status:

Recruiting

Sponsor:


Shattuck Labs, Inc.

How clear is this clinincal trial information?

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