Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04406623
Other study ID # SL03-OHD-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 29, 2020
Est. completion date February 2, 2023

Study information

Verified date May 2023
Source Shattuck Labs, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 2, 2023
Est. primary completion date February 2, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations. 2. Subject must have a histologically confirmed diagnosis of an unresectable, locally advanced or metastatic ovarian cancer, or primary peritoneal cancer or fallopian tube cancer. 3. 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. 4. Subjects should not be primary platinum refractory as defined by progressing during or within 1 month of upfront platinum therapy. 5. Has measurable disease by RECIST v1.1 using radiologic assessment. 6. Subject age is 18 years and older. 7. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 8. Has life expectancy of greater than 12 weeks. 9. Has adequate organ function. 10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 72 hours of D1 of IP. 11. Recovery from prior anti-cancer treatments including surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or = Grade 1. 12. 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: 1. Prior treatment with an anti-CD47 or anti-SIRPa targeting agent or a CD40 agonist. 2. Any anti-cancer therapy within the washout period prior to first dose (D1) of SL-172154. 3. 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. 4. Use of corticosteroids or other immunosuppressive medication, current or within 14 days of D1 of SL-172154 treatment. 5. Receipt of live attenuated vaccine within 28 days of D1 of IP. 6. Active or documented history of autoimmune disease. Exceptions include controlled Type I diabetes, vitiligo, alopecia areata or hypo/hyperthyroidism. 7. 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. 8. Active pneumonitis (i.e. drug-induced, idiopathic pulmonary fibrosis, radiation-induced, etc.). 9. Ongoing or active infection (e.g., no systemic antimicrobial therapy for treatment of infection within 5 days of D1 of IP). 10. Symptomatic peptic ulcer disease or gastritis, active diverticulitis, other serious gastrointestinal disease associated with diarrhea within 6 months of D1 of IP. 11. Clinically significant or uncontrolled cardiac/thromboembolic disease. 12. Untreated central nervous system or leptomeningeal metastases. 13. Women who are breast feeding. 14. 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. 15. 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. 16. Has undergone allogeneic stem cell transplantation or organ transplantation. 17. Known history or positive test for human immunodeficiency virus, or positive test for hepatitis B.

Study Design


Intervention

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

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States City of Hope Duarte California
United States START Midwest Grand Rapids Michigan
United States Sarah Cannon Research Institute Nashville Tennessee
United States Stephenson Cancer Center at Oklahoma University Oklahoma City Oklahoma
United States START Mountain Region West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
Shattuck Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety profile of SL-172154 Incidence of all treatment emergent adverse events From Day 1 to 90 days after Last Dose of SL-172154
Primary Maximum Tolerated Dose (MTD) 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 Establish the recommended Phase 2 dose (RP2D) for SL-172154 Establish the RP2D for SL-172154 Approximately 24 months
Secondary Assess preliminary evidence of anti-tumor activity of SL-172154 Disease assessment per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) Approximately 24 months
Secondary Immunogenicity to SL-172154 Number and proportion of participants with positive anti-drug antibody titer Approximately 24 months
Secondary Maximum serum concentration (Cmax) of SL-172154 The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses Approximately 24 months
Secondary Minimum serum concentration (Cmin) of SL-172154 The Cmin is the minimum observed serum concentration of SL-172154 following single and multiple doses Approximately 24 months
Secondary 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 Approximately 24 months
Secondary 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 Approximately 24 months
Secondary Terminal elimination half-life (t1/2) Terminal elimination half-life (t1/2) of SL-172154 Approximately 24 months
Secondary Clearance (CL) Clearance of Sl-172154 Approximately 24 months
Secondary Volume of distribution Volume of distribution of SL-172154 Approximately 24 months
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2