Leap Therapeutics Announces Completion of Enrollment in Part A of the DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients
Leap Therapeutics, Inc. (Nasdaq: LPTX) has completed enrollment in Part A of the Phase 2 DeFianCe study, which evaluates DKN-01, its anti-Dickkopf-1 antibody, in combination with bevacizumab and chemotherapy for advanced colorectal cancer (CRC).
This milestone is considered critical for the DKN-01 program, reflecting strong interest from investigators and patients. The study enrolled 33 patients in Part A and is set to expand into Part B with a total of 130 patients. The primary goal is to assess progression-free survival, with secondary objectives including overall response rate and overall survival.
DKN-01 is designed to disrupt the immune suppressive tumor microenvironment associated with CRC, offering potential therapeutic benefits. Initial data from the study is expected in mid-2023.
- Completion of Part A enrollment in the Phase 2 DeFianCe study indicates robust interest in DKN-01.
- The study aims to address an unmet medical need for second-line CRC treatment.
- None.
"The completion of enrollment of Part A of the DeFianCe study is an important milestone for the DKN-01 colorectal cancer development program," said
The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The study began with an initial Part A cohort that has enrolled 33 patients and is designed to expand into a 130-patient Part B randomized controlled trial. The primary objective is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival.
About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (
About Colorectal Cancer
Colorectal cancer (CRC) includes colon cancer, rectal cancer, and anal cancer. When the symptoms of CRC appear, such as rectal bleeding, anemia, or abdominal pain, most patients are already in the advanced stage where cancers are aggressive, malignant, and metastatic. CRC is the third most frequent cancer globally and the second leading cause of cancer-related death. According to the WHO, there were nearly 2,000,000 new cases of CRC in 2020, with nearly 1,000,000 deaths. It is estimated that there will be approximately 150,000 cases of CRC in the US in 2023, resulting in more than 50,000 deaths.
About
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements.
All statements, other than historical facts, including statements regarding Part A of the DeFianCe trial; the anticipated timing for the release of clinical data, and any outcomes of such trial; the potential, safety, efficacy, and regulatory and clinical progress of Leap's product candidates; our future preclinical and clinical development plans in connection with our programs; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or any of its other programs; (iv) whether any Leap clinical trials and products will receive approval from the
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