Trial Title:
DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
NCT ID:
NCT05785754
Condition:
Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DCSZ11
Description:
A monoclonal antibody that binds to CD93, DCSZ11 will be administered as a single
intravenous (IV) infusion on Day 1 in each 21-day cycle.
Arm group label:
Phase 1a Dose Escalation Combination
Arm group label:
Phase 1a Dose Escalation Monotherapy
Arm group label:
Phase 1b Dose Expansions
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab injection
Arm group label:
Phase 1a Dose Escalation Combination
Arm group label:
Phase 1b Dose Expansions
Summary:
This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11, an
anti-CD93 monoclonal antibody, as a monotherapy and in combination in patients with
advanced or metastatic solid tumors.
Detailed description:
The drug being tested in this study is called DCSZ11. DCSZ11 is being tested to treat
people who have advanced or metastatic solid tumors. The study will include a dose
escalation phase and a dose expansion phase.
The study will enroll approximately 138 patients in dose escalation, and approximately
113 participants in the dose expansion phase. Participants will receive escalating doses
of DCSZ11 and a fixed dose of pembrolizumab until DCSZ11 doses for phase 1b are selected:
- Phase 1a DCSZ11 monotherapy Dose Escalation.
- Phase 1a DCSZ11 in combination with fixed dose of pembrolizumab Dose Escalation.
Once Phase 1b doses are selected for Phase 1b, participants of select advanced or
metastatic solid tumors will receive DCSZ11 in below defined cohorts in Phase 1b:
- Phase 1b cohort 1 NSCLC.
- Phase 1b cohort 2 Microsatellite Stable Colorectal Cancer (MSS-CRC) without liver
involvement.
- Phase 1b cohort 3 MSS-CRC with liver involvement.
This multi-center trial will be conducted worldwide. The overall time to participate in
this study is 60 months. Participants will make multiple visits to the clinic, and
survival follow-up for a maximum of up to 12 months after the last dose of the study
drug.
Criteria for eligibility:
Criteria:
Selected Inclusion Criteria:
1. Male or female patients ≥ 18 years of age.
2. Have a histologically or cytologically documented, advanced (metastatic and/or
unresectable) solid tumor that has progressed on or after standard therapy
(relapsed/refractory patients; patients must have failed at least one prior line of
therapy) or for whom there is no effective standard therapy based on the
Investigator's judgment.
3. At least 1 measurable lesion according to RECIST Version 1.1.
4. Patients must have a lesion that can be biopsied with acceptable clinical risk and
agree to have a biopsy at Screening and on treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
6. Adequate organ function and bone marrow reserve as indicated by the following
laboratory assessments performed within 14 days prior to the first dose of study
drug.
7. For female patients of childbearing potential must have a negative serum beta-human
chorionic gonadotropin (β-hCG) pregnancy test and agree to use highly effective
contraception.
8. For men who are not surgically sterile must agree to remain abstinent (refrain from
heterosexual intercourse) or use contraception, and agreement to refrain from
donating sperm.
9. The patient is capable of understanding and complying with the protocol and has
signed the required ICF. The appropriate ICF must be signed before relevant study
procedures are performed. If applicable, the female partner of a male patient
understands and signs the pregnant partner's ICF.
Selected Exclusion Criteria:
1. Received systemic anticancer treatments or investigational products within 14 days
before the first dose of the study drug or 5 half-lives, whichever is shorter.
2. Received extended field radiotherapy ≤4 weeks before the start of treatment (≤7 days
for limited field radiation for palliation outside the chest or brain).
3. Patients with second malignancy within the previous 3 years, except treated basal
cell or localized squamous skin carcinomas, localized prostate cancer, cervical
carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or
other malignancy for which the patient is not on active anticancer therapy.
4. Systemic arterial thrombotic or embolic events, such as cerebrovascular accident
(including ischemic attacks) or hemoptysis within 3 months prior to the first dose
of study drug.
5. Systemic venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial
events (eg, pulmonary embolism) within 1 month prior to the first dose of study
drug. Patients with venous thrombotic events prior to the first dose of study drug
on stable anticoagulation therapy are eligible.
6. Left ventricular ejection fraction (LVEF) < 50%
7. Major surgery within 4 weeks and minor surgery within 2 weeks of the first dose of
study drug; following surgeries, all surgical wounds must be healed and free of
infection or dehiscence.
8. Marked proteinuria ≥ 2 g/24 hours and/or nephrotic syndrome. Patients with
proteinuria 2+ or greater urine dipstick reading should undergo further assessment,
eg, a 24-hour urine collection.
9. For patients receiving a combination with pembrolizumab:
1. History of adverse events related to immunotherapy that required treatment
discontinuation.
2. History of autoimmune disease requiring systemic immunosuppressive therapy with
daily doses of prednisone >10 mg/day or equivalent doses, or any other form of
immunosuppressive therapy. Hormone therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered an excluded form of systemic treatment of an
autoimmune disease.
3. History of noninfectious pneumonitis that required steroids or a history of
interstitial lung disease.
4. Evidence of active, noninfectious pneumonitis.
5. History of allogeneic tissue or solid organ transplant.
10. History of any of the following ≤6 months before first dose: congestive heart
failure New York Heart Association Grade III or IV, unstable angina, myocardial
infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension
despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias >Grade
2, or any other serious cardiac condition (e.g., pericardial effusion or restrictive
cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is
allowed.
11. Psychiatric illness/social circumstances that would limit compliance with study
requirements and substantially increase the risk of AEs or has compromised ability
to provide written informed consent.
12. Female patients who are pregnant or lactating and breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
HonorHealth
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute Denver Healthone
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06519
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
MonteFiore
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Scientia Clinical Research
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Facility:
Name:
Southern Oncology Clinical Research Unit (SOCRU)
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Queen Elizabeth Hospital (TQEH)
Address:
City:
Woodville South
Zip:
5011
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cabrini Hospital
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research Limited
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Townsville Hospital
Address:
City:
Douglas
Zip:
QLD4810
Country:
Australia
Status:
Recruiting
Facility:
Name:
Liverpool Hospital
Address:
City:
Liverpool
Zip:
NSW2170
Country:
Australia
Status:
Recruiting
Facility:
Name:
Mater Misericordiae Health Services Brisbane Ltd
Address:
City:
South Brisbane
Zip:
QLD4101
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sydney Adventist Hospital
Address:
City:
Wahroonga
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Dong-a University Hospital
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Cha University Bundang Medical Center
Address:
City:
Gyeonggi-do
Zip:
13496
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Kaohsiung Medical University Chung-ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Start date:
June 28, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
DynamiCure Biotechnology
Agency class:
Industry
Source:
DynamiCure Biotechnology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785754
