Advanced or Metastatic Solid Tumors Clinical Trial
Official 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
NCT number | NCT05785754 |
Other study ID # | DCSZ11-101 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 28, 2023 |
Est. completion date | May 2025 |
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.
Status | Recruiting |
Enrollment | 257 |
Est. completion date | May 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 (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 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Southern Oncology Clinical Research Unit (SOCRU) | Bedford Park | South Australia |
Australia | Monash Health | Clayton | Victoria |
Australia | Cabrini Hospital | Malvern | Victoria |
Australia | Linear Clinical Research Limited | Nedlands | Western Australia |
Australia | Scientia Clinical Research | Randwick | New South Wales |
Australia | St Vicent's Hospital | Sydney | New South Wales |
Australia | The Queen Elizabeth Hospital (TQEH) | Woodville South | South Australia |
United States | University of Colorado | Aurora | Colorado |
United States | University of Alabama | Birmingham | Alabama |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | MonteFiore | Bronx | New York |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of Miami | Miami | Florida |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Mayo Clinic | Phoenix | Arizona |
United States | Mayo Clinic | Rochester | Minnesota |
United States | HonorHealth | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
DynamiCure Biotechnology |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1a: Incidence of dose limiting toxicites (DLTs) | 21 days | ||
Primary | Phase 1a: Frequency and severity of treatment emergent adverse events | up to 3 years | ||
Primary | Phase 1b: Overall response rate (ORR) per Investigator-assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) | 1 year | ||
Secondary | Phase 1a: Overall response rate (ORR) per Investigator-assessed RECIST v1.1 | 1 year | ||
Secondary | 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) | 1 year | ||
Secondary | Phase 1a and b: Duration of response (DOR) as determined per Investigator assessment by RECIST v1.1 and iRECIST | 1 year | ||
Secondary | Phase 1 a and b: Disease control rate (DCR) as determined per Investigator assessment by RECIST v1.1 and iRECIST. | 1 year | ||
Secondary | Phase 1a and b: Progression free survival (PFS) as determined per Investigator assessment by RECIST v1.1 and iRECIST. | 3 years | ||
Secondary | Phase 1 a and b: Overall survival (OS) | 3 years | ||
Secondary | Phase 1 and b: Pharmacokinetic parameters of DCSZ11 | 2 years | ||
Secondary | Phase 1 a and b: Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAbs) against DCSZ11 | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05017012 -
A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of MK-3475A (Pembrolizumab Formulated With MK-5180) In Advanced Solid Tumors (MK-3475A-C18)
|
Phase 1 | |
Completed |
NCT02261532 -
A Phase I Study of TAS-102 in Solid Tumors
|
Phase 1 | |
Completed |
NCT00748553 -
A Phase I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03248843 -
A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05572684 -
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT04003623 -
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
|
Phase 2 | |
Terminated |
NCT05496595 -
DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT01928394 -
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01506934 -
A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT03730337 -
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04586270 -
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
|
Phase 1 | |
Recruiting |
NCT06248411 -
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06389526 -
A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT03665285 -
A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05957081 -
Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309
|
Phase 1 | |
Active, not recruiting |
NCT03316638 -
A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT01355302 -
E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01014429 -
Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06074497 -
A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06448364 -
A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination
|
Phase 1 |