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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05785754




Registration number
NCT05785754
Ethics application status
Date submitted
14/03/2023
Date registered
27/03/2023

Titles & IDs
Public title
DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
DCSZ11-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DCSZ11
Treatment: Drugs - Pembrolizumab

Experimental: Phase 1a Dose Escalation Monotherapy - Dose escalation to investigate the safety and tolerability of DCSZ11.

Experimental: Phase 1a Dose Escalation Combination - Dose escalation to investigate safety and tolerability, and determine DCSZ11 Phase 1b doses in combination with pembrolizumab.

Experimental: Phase 1b Dose Expansions - Dose expansion to further investigate the safety, tolerability, and preliminary evidence of antitumor activity of the combination with pembrolizumab in select tumor indications.


Treatment: Drugs: DCSZ11
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.

Treatment: Drugs: Pembrolizumab
Pembrolizumab injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Incidence of dose limiting toxicites (DLTs)
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Phase 1a: Frequency and severity of treatment emergent adverse events
Timepoint [2] 0 0
up to 3 years
Primary outcome [3] 0 0
Phase 1b: Overall response rate (ORR) per Investigator-assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Timepoint [3] 0 0
1 year
Secondary outcome [1] 0 0
Phase 1a: Overall response rate (ORR) per Investigator-assessed RECIST v1.1
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Phase 1a and b: Overall response rate (ORR) per Investigator-assessed consensus guideline developed by the RECIST Working Group for the use of modified RECIST, Version 1.1 in cancer immunotherapy trials (iRECIST)
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Phase 1a and b: Duration of response (DOR) as determined per Investigator assessment by RECIST v1.1 and iRECIST
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Phase 1 a and b: Disease control rate (DCR) as determined per Investigator assessment by RECIST v1.1 and iRECIST.
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Phase 1a and b: Progression free survival (PFS) as determined per Investigator assessment by RECIST v1.1 and iRECIST.
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Phase 1 a and b: Overall survival (OS)
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Phase 1 and b: Pharmacokinetic parameters of DCSZ11
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Phase 1 a and b: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCSZ11
Timepoint [8] 0 0
2 years

Eligibility
Key inclusion criteria
Selected

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 (ß-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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
257
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
Southern Oncology Clinical Research Unit (SOCRU) - Bedford Park
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital (TQEH) - Woodville South
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [7] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment hospital [8] 0 0
Townsville Hospital - Douglas
Recruitment hospital [9] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [10] 0 0
Mater Misericordiae Health Services Brisbane Ltd - South Brisbane
Recruitment hospital [11] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3144 - Malvern
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
QLD4810 - Douglas
Recruitment postcode(s) [9] 0 0
NSW2170 - Liverpool
Recruitment postcode(s) [10] 0 0
QLD4101 - South Brisbane
Recruitment postcode(s) [11] 0 0
- Wahroonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Busan
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Gyeonggi-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Taiwan
State/province [15] 0 0
Kaohsiung
Country [16] 0 0
Taiwan
State/province [16] 0 0
Tainan
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DynamiCure Biotechnology
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sr Medical Director
Address 0 0
Country 0 0
Phone 0 0
+1 (781) 373-9136
Fax 0 0
Email 0 0
alejandrogomez@dynamicure.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05785754