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Leap Therapeutics (LPTX)
:LPTX
Bevacizumab, Folfiri, Folfox, Dkn-01
Colorectal Cancer, Colorectal Adenocarcinoma, Colorectal Cancer Metastatic, Colo-Rectal Cancer
Phase II
Completed
Phase 2 Study of DKN-01 in Colorectal Cancer
Jul 21, 2022
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Fluorouracil, Oxaliplatin, Dkn-01 300Mg, Dkn-01 600Mg, Dkn-01 400Mg, Tislelizumab 200Mg, Tislelizumab 400Mg, Capecitabine 1000Mg/ M2 Twice Daily (Bid), Leucovorin Calcium
Gastroesophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma
Phase II
Terminated
A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
Apr 23, 2020
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Paclitaxel, 300Mg Dkn-01, 600Mg Dkn-01
Ovarian Cancer, Endometrial Cancer, Uterine Cancer, Carcinosarcoma
Phase II
Completed
A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma
Jan 02, 2018
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Trx518 Monotherapy, Trx518 With Gemcitabine, Trx518 With Pembrolizumab, Trx518 With Nivolumab
Solid Tumors
Phase I
Completed
Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab
Dec 01, 2015
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Gemcitabine, Cisplatin, Dkn-01
Bile Duct Cancer, Cholangiocarcinoma, Carcinoma Of Intrahepatic And Extra-Hepatic Biliary System, Carcinoma Of Gallbladder
Phase I
Completed
Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder
Feb 18, 2015
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Pembrolizumab, Paclitaxel, Dkn-01 150 Mg, Dkn-01 300 Mg
Gastroesophageal Cancer, Gastric Adenocarcinoma, Squamous Cell Carcinoma, Adenocarcinoma Of The Gastroesophageal Junction, Esophageal Neoplasms
Phase I
Completed
A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
Dec 11, 2013
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Standard of Care, Dkn-01 300 Mg, Dkn-01 600 Mg
Multiple Myeloma
Phase I
Completed
A Study of DKN-01 and Lenalidomide/Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Oct 18, 2012
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Trx518
Unresectable Stage Iii Or Stage Iv Malignant Melanoma Or Other Solid Tumor Malignancies
Phase I
Completed
Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors
Nov 09, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Leap Therapeutics (LPTX) have in its pipeline
LPTX is currently developing the following drugs: Bevacizumab, Folfiri, Folfox, Dkn-01, Fluorouracil, Oxaliplatin, Dkn-01 300Mg, Dkn-01 600Mg, Dkn-01 400Mg, Tislelizumab 200Mg, Tislelizumab 400Mg, Capecitabine 1000Mg/ M2 Twice Daily (Bid), Leucovorin Calcium, Paclitaxel, 300Mg Dkn-01, 600Mg Dkn-01. These drug candidates are in various stages of clinical development as the company works toward FDA approval.