DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT05496595 |
Recruitment Status :
Terminated
(Review of Data, and our other compound is a better option)
First Posted : August 11, 2022
Last Update Posted : March 6, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 9, 2022 | ||||
First Posted Date ICMJE | August 11, 2022 | ||||
Last Update Posted Date | March 6, 2024 | ||||
Actual Study Start Date ICMJE | October 26, 2022 | ||||
Actual Primary Completion Date | February 5, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors | ||||
Official Title ICMJE | A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors | ||||
Brief Summary | Study DCBY02-101 is a multicenter, open-label, Phase 1 study to assess the effects of anti-CD93 mAb (DCBY02) as a monotherapy in patients with advanced or metastatic solid tumors. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced or Metastatic Solid Tumors | ||||
Intervention ICMJE | Drug: DCBY02
A monoclonal antibody that binds to CD93, DCBY02 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
5 | ||||
Original Estimated Enrollment ICMJE |
96 | ||||
Actual Study Completion Date ICMJE | February 5, 2024 | ||||
Actual Primary Completion Date | February 5, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Selected Inclusion Criteria: Male or female patients ≥ 18 years of age. Histologically or cytologically confirmed incurable or metastatic solid tumors - colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular, ovarian, cervical cancer, GBM or with a potential benefit from PD-1/PD-L1 blockade where hypoxia is associated with resistance to PD-1 blockade eg, as reported for or head and neck cancer and is not amenable to curative treatment. The malignancy must have progressed after at least 1 available standard therapy for incurable disease, and the patient has failed or is intolerant to all available therapies known to be active for the malignancy and have meaningful impact on the disease. Male or female patients ≥18 years of age 2. Histologically or cytologically confirmed incurable or metastatic solid tumors (including but not limited to colorectal, gastric, non-small cell lung, renal cell, breast, hepatocellular, ovarian, cervical, or head and neck cancer; or GBM). The malignancy must have progressed after at least 1 available standard therapy for incurable disease, and the patient has failed or is intolerant to all available therapies known to be active for the malignancy and have a meaningful impact on the disease. The Investigator needs to discuss any available standard options with the patient and document the benefits and risks of all options along with the rationale for recommending the study. Note: For patients who are intolerant to or refuse standard of care therapy for recurrent disease, reasons must be documented. 3. Patients with unresectable or metastatic solid tumors, except for patients with GBM, must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Screening and an on-treatment biopsy. Every effort must be made to take the second biopsy from the same lesion of the biopsy at Screening.
a) A lesion in a previously irradiated area is eligible to be considered as a measurable disease as long as there is objective evidence of progression of the lesion before study enrollment. b) In Cohort 1 and Cohort 2, patients without measurable lesions are eligible. c) Patients with GBM must meet the RANO criteria of measurable disease (10 mm × 10 mm) for the post-gadolinium primary tumor weighted images (T1WI) 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:
Note: Patients with inherited disorders of bilirubin metabolism should be discussed with the Sponsor. c) Renal function: Creatinine clearance ≥ 30 mL/minute based on Cockcroft-Gault estimation. d) Coagulation profile: Prothrombin time (PT) - international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to the first dose of study drug may have PT/INR measurements > 1.5 × ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to enrollment. 7. Recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela. Note: Neuropathy and/or hearing impairment Grade ≤2, any grade alopecia, or autoimmune endocrinopathies with stable replacement therapy are permitted. 8. Female patients of childbearing potential must:
Examples of highly effective contraception include the following: i) Combined hormonal contraceptives (containing both estrogen and progesterone) associated with inhibition of ovulation; may be oral, intravaginal, or transdermal) ii) Intra-uterine device iii) Intra-uterine, hormone-releasing system iv) Bilateral tubal occlusion v) Vasectomized partner vi) Sexual abstinence. 9. Male patients who are not surgically sterile must: Agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating sperm, as defined below: a) With a female partner of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year and must refrain from donating sperm during the treatment period and for at least 60 days after the final dose of DCBY02. b) With pregnant female partners, men must remain abstinent or use a condom to avoid exposing the embryo during the treatment period and for at least 60 days after the final dose of DCBY02. 10. Capable of understanding and complying with the protocol and has signed the required informed consent form (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. Selection Exclusion Criteria 1. Received treatment with systemic anticancer treatments or investigational products within 14 days before the first dose of study drug or 5 half-lives, whichever is shorter. Note: Low-dose steroids (oral prednisone or equivalent ≤10 mg per day), hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors are allowed. 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. These patients must be discussed with the medical monitor prior to enrollment. 3. Patients with known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided that:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05496595 | ||||
Other Study ID Numbers ICMJE | DCBY02-101 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | DynamiCure Biotechnology | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | DynamiCure Biotechnology | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | DynamiCure Biotechnology | ||||
Verification Date | March 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |