SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

  • STATUS
    Recruiting
  • End date
    Apr 5, 2022
  • participants needed
    87
  • sponsor
    Shattuck Labs, Inc.
Updated on 22 August 2021
vasectomy
cancer
lymphoma
hodgkin's disease
measurable disease
carcinoma
hepatitis
squamous cell carcinoma
lung cancer
cell transplantation
psychiatric illness
chemotherapy regimen
gastric cancer
cancer treatment
solid tumors
cancer chemotherapy
adenocarcinoma
solid tumour
hepatitis b core antibody
diffuse lymphoma
lung carcinoma
microsatellite instability high
squamous cell cancers
lymphoma, diffuse

Summary

This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas.

Description

This is a Phase 1 first in human, open label, multi-center, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, anti-tumor activity and pharmacodynamic effects of SL-279252 in subjects with advanced solid tumors or lymphomas. The study design consists of Dose Escalation and Dose Expansion Cohorts. In the dose escalation phase of the study, subjects will be enrolled into sequential dose levels. During dose escalation, two possible schedules for administration of SL-279252 may be explored. The MTD or MAD may be determined for either schedule. Based on accumulating data from the dose escalation phase, including safety, PK, pharmacodynamic and anti-tumor activity, up to two dose expansion cohorts may be opened. The primary objective of the expansion phase is to further refine the safety and tolerability of SL-279252. The expansion cohorts will evaluate one or two doses of SL-279252 using one selected schedule. At the end of dose escalation and dose expansion, safety, PK, anti-tumor activity, and pharmacodynamic data will be reviewed to identify the RP2D.

Details
Condition Non-Small Cell Lung Cancer, Adenocarcinoma, Hodgkin's Disease, Diffuse Large B-Cell Lymphoma, Malignant neoplasm of kidney, melanoma, Transitional cell carcinoma, Renal Cell Carcinoma, skin cancer, Lymphoma, Metastatic Melanoma, Gastric Adenocarcinoma, Squamous Cell Carcinoma of the Head and Neck, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Squamous Cell Carcinoma of the Anus, Squamous Cell Carcinoma of Cervix, Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of the Skin, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Cervix, Kidney Cancer, Malignant Melanoma, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Mismatch Repair Deficient or MSI-High Solid Tumors, Mismatch Repair Deficient or MSI-High Solid Tumors, Urothelial Carcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Mismatch Repair Deficient or MSI-High Solid Tumors, Mismatch Repair Deficient or MSI-High Solid Tumors, clear cell renal cell carcinoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, nsclc, stomach adenocarcinoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, squamous cell skin cancer, Mismatch Repair Deficient or MSI-High Solid Tumors, Mismatch Repair Deficient or MSI-High Solid Tumors, Mismatch Repair Deficient or MSI-High Solid Tumors
Treatment SL-279252
Clinical Study IdentifierNCT03894618
SponsorShattuck Labs, Inc.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Myocarditis
Unstable angina within 6 months from D1 of IP
Acute myocardial infarction within 6 months from D1 of IP
Uncontrolled hypertension
New York Heart Association (NYHA) Class II, III or IV congestive heart failure
Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, second- or third- degree atrioventricular block without a pacemaker, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia requiring therapy) 12. Untreated central nervous system (CNS) or leptomeningeal metastases. Subjects with treated CNS metastases must have completed definitive treatment (radiotherapy and/or surgery) > 2 weeks prior to D1 of IP and no longer require steroids. 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 (positive for hepatitis B surface antigen [HBsAg]) or hepatitis C virus ([HCV]; if HCV antibody (Ab) test is positive check for HCV ribonucleic acid [RNA])
(NOTE: Hepatitis B virus (HBV): Subjects who are hepatitis B core antibody [HBcAb] positive, but HBsAg negative are eligible for enrollment. HCV: Subjects who are HCV Ab positive, but HCV RNA negative are eligible for enrollment)

Exclusion Criteria

Has received more than two prior checkpoint inhibitor containing treatment regimens (regimen refers to either monotherapy or combination immunotherapies) or has had prior treatment with an OX40 agonist
Prior PD-1/L1 therapy is not required
\. Refractory to last PD-1/L1 inhibitor-based therapy which is defined as
disease progression within 3 months of treatment initiation
Subjects must have had clinical benefit (stable disease or response) to last
Participants are excluded from the study if any of the following criteria
PD-1/L1 inhibitor-based therapy for at least three months to be eligible
\. Any anti-cancer therapy within the time intervals noted below prior to
apply
first dose (D1) of SL-279252
Therapy Washout period Chemotherapy 3 weeks Hormonal therapy 3 weeks PD-1/L1
inhibitor and other immunotherapies not otherwise specified 3 weeks Tumor
vaccine 4 weeks Cell-based therapy 8 weeks Other mAbs or biologic therapies 3
weeks Major surgery 2 weeks Radiation (except palliative intent which does not
require washout) 2 weeks
\. Concurrent chemotherapy, immunotherapy, biologic or hormonal therapy 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 IP with the following exceptions (i.e., the following
are allowed during treatment with or within14 days of D1 of IP)
Topical, intranasal, inhaled, ocular, intraarticular corticosteroids
Physiological doses of replacement steroid (e.g., for adrenal insufficiency) provided 10 mg/day of prednisone or equivalent
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