Overview

Phase 1 Study of SL-172154 (SIRPα-Fc-CD40L) in Subjects With Ovarian Cancer

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shattuck Labs, Inc.
Criteria
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-SIRPα 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.