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Leap Therapeutics

Leap Therapeutics logo
🇺🇸United States
Ownership
Public
Established
2011-01-01
Employees
54
Market Cap
$113.2M
Website
http://www.leaptx.com

Clinical Trials

11

Active:2
Completed:7

Trial Phases

2 Phases

Phase 1:7
Phase 2:3

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 1
7 (70.0%)
Phase 2
3 (30.0%)

Phase 2 Study of DKN-01 in Colorectal Cancer

Phase 2
Active, not recruiting
Conditions
Colorectal Cancer
Colo-rectal Cancer
Colorectal Cancer Metastatic
Colorectal Adenocarcinoma
Interventions
Drug: FOLFIRI
Drug: FOLFOX
First Posted Date
2022-07-29
Last Posted Date
2025-04-02
Lead Sponsor
Leap Therapeutics, Inc.
Target Recruit Count
188
Registration Number
NCT05480306
Locations
🇺🇸

The University of Arizona Cancer Center, Tucson, Arizona, United States

🇺🇸

UCLA, Los Angeles, California, United States

🇺🇸

Florida Cancer Specialists & Research Institute (FCS), Cape Coral, Florida, United States

and more 34 locations

Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

Conditions
Esophageal Neoplasm
Adenocarcinoma of the Gastroesophageal Junction
GastroEsophageal Cancer
Squamous Cell Carcinoma
Gastric Adenocarcinoma
Endometrial Cancer
Uterine Cancer
Ovarian Cancer
Carcinosarcoma
Gastric Cancer
First Posted Date
2020-12-23
Last Posted Date
2025-04-01
Lead Sponsor
Leap Therapeutics, Inc.
Registration Number
NCT04681248
Locations
🇺🇸

University of Alabama, Birmingham, Alabama, United States

🇺🇸

Cedars Sinai Medical Care Foundation, Los Angeles, California, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

and more 2 locations

A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

Phase 2
Active, not recruiting
Conditions
Gastric Adenocarcinoma
Gastric Cancer
GastroEsophageal Cancer
Interventions
First Posted Date
2020-04-27
Last Posted Date
2024-01-22
Lead Sponsor
Leap Therapeutics, Inc.
Target Recruit Count
232
Registration Number
NCT04363801
Locations
🇺🇸

Mayo Clinic Cancer Center, Phoenix, Arizona, United States

🇺🇸

University of Arizona, Tucson, Arizona, United States

🇺🇸

City of Hope, Duarte, California, United States

and more 45 locations

A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors

Phase 1
Terminated
Conditions
Solid Tumors
Advanced Triple Negative Breast Cancer
Advanced Hormone Receptor Positive/Endocrine Refractory Breast Cancer
Advanced Metastatic Castration-Resistant Prostate Cancer
Advanced Platinum-Resistant Ovarian Cancer
Interventions
First Posted Date
2019-03-04
Last Posted Date
2023-11-30
Lead Sponsor
Leap Therapeutics, Inc.
Target Recruit Count
10
Registration Number
NCT03861403
Locations
🇺🇸

Horizon Oncology Research, Lafayette, Indiana, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

and more 1 locations

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

Phase 2
Completed
Conditions
Endometrial Cancer
Uterine Cancer
Ovarian Cancer
Carcinosarcoma
Interventions
Drug: 300mg DKN-01
Drug: 600mg DKN-01
First Posted Date
2018-01-10
Last Posted Date
2023-07-12
Lead Sponsor
Leap Therapeutics, Inc.
Target Recruit Count
111
Registration Number
NCT03395080
Locations
🇺🇸

University of Alabama, Birmingham, Alabama, United States

🇺🇸

HonorHealth, Scottsdale, Arizona, United States

🇺🇸

Florida Cancer Specialists & Research Institute, West Palm Beach, Florida, United States

and more 14 locations
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News

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.

Leap Therapeutics' FL-501 Shows Promise in Reversing Cancer Cachexia in Preclinical Studies

Leap Therapeutics' novel GDF-15 neutralizing antibody FL-501 demonstrated superior efficacy in preclinical models, fully restoring body composition and reversing key indicators of cancer cachexia.

Leap Therapeutics Reports Mixed Phase II Results for Sirexatamab in Gastrointestinal Cancers

Leap Therapeutics' anti-DKK1 antibody sirexatamab shows promising results in colorectal cancer trials while falling short in gastric cancer studies, leading to significant stock impact.

Sirexatamab Shows Promise in Colorectal Cancer, Fails to Meet Endpoints in Gastric Cancer

Leap Therapeutics' DeFianCe study showed a 35% objective response rate (ORR) in second-line colorectal cancer (CRC) patients treated with sirexatamab, bevacizumab, and chemotherapy.

Leap Therapeutics Announces Enrollment Completion in Phase 2 DeFianCe Study and FL-501 Development

Leap Therapeutics completed enrollment in Part B of the Phase 2 DeFianCe study, evaluating DKN-01 with bevacizumab and chemotherapy for second-line advanced colorectal cancer, with data expected mid-2025.

DKN-01 Plus Tislelizumab and Chemotherapy Shows Promise in Advanced Gastric Cancer

A phase IIa trial of DKN-01 with tislelizumab and chemotherapy demonstrated a 73% objective response rate in advanced gastric or gastroesophageal junction adenocarcinoma.

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