Trial Title:
WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
NCT ID:
NCT05678998
Condition:
Advanced or Metastatic Solid Tumors
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Conditions: Keywords:
WTX-330
Cancer
Immunotherapy
Interleukin-12
IL-12
Checkpoint inhibitor resistance
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
WTX-330
Description:
Investigation Product
Arm group label:
WTX-330 dose escalation
Arm group label:
WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A)
Arm group label:
WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B)
Summary:
A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a
monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.
Detailed description:
This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety,
tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12
prodrug, when administered as a monotherapy to patients with advanced or metastatic solid
tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with
advanced and/or metastatic solid tumors who are refractory to all standard of care
therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with
indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate
primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will
enroll patients with tumor types for which CPI therapy is not indicated/approved.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Dose Escalation: A diagnosis of a relapsed/refractory advanced or metastatic solid
tumor for which the patient has progressed on or is intolerant of standard therapy,
or for whom no standard therapy with proven benefit exists.
3. Dose Expansion: A diagnosis of a relapsed/refractory advanced or metastatic
malignancy for which the patient has progressed on or is intolerant of standard
therapy, or for whom no standard therapy with proven benefit exists. For Arm A,
patients must have a tumor type for which a CPI is indicated/approved and
demonstrate primary or secondary resistance to a standard of care anti-PD(L)1-based
treatment regimen. For Arm B, patients must have a solid tumor type for which a CPI
is not indicated/approved or non-Hodgkin lymphoma.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. At least one measurable lesion per RECIST 1.1 or an evaluable lesion per Lugano
classification (for lymphoma).
6. Agrees to undergo a pre-treatment and on-treatment biopsy of a primary or metastatic
solid tumor or lymphoma lesion.
7. HIV-infected patients must be on antiretroviral therapy and have well-controlled
disease.
8. Adequate organ and bone marrow function.
9. Willingness of men and women of reproductive potential to use highly effective birth
control for the duration of treatment and for 4 months following the last dose of
study drug.
10. Additional criteria may apply.
Exclusion Criteria:
1. A history of another active malignancy (i.e., a second cancer) within the previous 2
years, except for localized cancers that are not related to the current cancer being
treated, are considered cured, and, in the opinion of the Investigator, present a
low risk of recurrence. These exceptions include but are not limited to basal or
squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the
prostate, cervix, or breast.
2. Received prior treatment with IL-12, including by intratumoral injection.
3. Patients with primary CNS malignancies.
4. Presence of CNS metastases that are symptomatic and/or require local CNS directed
therapy (such as XRT or surgery) or increasing doses of corticosteroids within 2
weeks prior to the first dose of study drug. Patients with treated brain metastases
should be neurologically stable and receiving ≤ 10 mg per day of prednisone or
equivalent prior to study entry.
5. Significant cardiovascular disease.
6. Significant electrocardiogram (ECG) abnormalities
7. Active autoimmune disease requiring systemic treatment in the past 2 years.
8. Diagnosis of immunodeficiency, on immunosuppressive therapy, or receiving chronic
systemic or enteric steroid therapy (dose > 10 mg/day of prednisone or equivalent).
9. Prior receipt of an allogeneic stem cell transplant or allogeneic CAR-T cell
therapy.
10. Major surgery (excluding placement of vascular access) within 2 weeks prior to the
first dose of study drug.
11. Investigational agent or anticancer therapy (including chemotherapy, biologic
therapy, immunotherapy, anticancer Chinese medicine, or anticancer herbal remedy)
within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of
study drug.
12. Radiotherapy within 2 weeks of the start of study treatment. A 1-week washout is
permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
13. Any unresolved toxicities from prior therapy greater than NCI-CTCAE version 5.0
Grade 1 at the time of starting study drug with the exception of alopecia and Grade
2 platinum therapy-related neuropathy.
14. Use of sensitive substrates of major CYP450 isozymes.
15. Any illness, medical condition, organ system dysfunction, or social situation
(including mental illness or substance abuse), that may interfere with a patient's
ability to sign the ICF, adversely affect the patient's ability to cooperate and
participate in the study, or compromise interpretation of study results.
16. Received a live vaccine within 30 days of the first dose of study drug.
17. Active, uncontrolled systemic bacterial, viral, or fungal infection.
18. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric
Castleman Disease.
19. Active infection with hepatitis B as determined by hepatitis B surface antigen and
hepatitis B core antibody, or hepatitis B virus deoxyribonucleic acid (DNA) by
quantitative polymerase chain reaction (qPCR) testing.
20. Active infection with hepatitis C as determined by hepatitis C virus (HCV) antibody
or HCV RNA by qPCR testing.
21. Pregnant or lactating.
22. History of hypersensitivity to any of the study drug components.
23. Additional criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Nurse Navigation
Phone:
480-323-1339
Email:
clinicaltrials@honorhealth.com
Facility:
Name:
Emory Winship Cancer Institute of Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Suzanne Scott
Phone:
404-778-4083
Email:
suzanne.e.scott@emory.edu
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
312-695-1301
Email:
cancertrials@northwestern.edu
Facility:
Name:
Indiana University
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anne Younger
Phone:
317-274-0951
Email:
anefoste@iu.edu
Facility:
Name:
Mass General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aparna Parikh
Phone:
617-724-4000
Email:
aparna.parikh@mgh.harvard.edu
Facility:
Name:
Facility Name: Roswell Park Comprehensive Cancer Care
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kim Benczkowski (Brosius)
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Facility:
Name:
Providence Cancer Institute Franz Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Patrick Rethwisch
Phone:
503-215-6450
Email:
patrick.rethwisch@providence.org
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julie Urban
Phone:
412-623-7396
Email:
IDDCReferrals@upmc.edu
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cynthia Deleon
Phone:
210-580-9521
Email:
cdeleon@nextoncology.com
Start date:
December 6, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Werewolf Therapeutics, Inc.
Agency class:
Industry
Source:
Werewolf Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05678998
