A Phase 2 interventional study of Paclitaxel and 300mg DKN-01 in Endometrial Cancer, Uterine Cancer and Ovarian Cancer, sponsored by Leap Therapeutics, Inc.. Completed at 17 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Leap Therapeutics, Inc. · Phase 2, Interventional, and Treatment
A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination with Paclitaxel in Patients With Recurrent Epithelial Endometrial Cancer, Epithelial Ovarian Cancer, or Carcinosarcoma
This study employs a "basket" design to concurrently investigate DKN-01 as monotherapy and in combination with paclitaxel in patients with recurrent epithelial endometrial cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (malignant mixed Mullerian tumor [MMMT]. Thus, 6 distinct patient groups are being independently investigated:
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's enrollment of 111 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Leap Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis:
Refractory or intolerant to at least one prior standard therapy(ies) for or locally advanced disease (see Inclusion Criterion #1c for Groups 5-6).
performance status (PS) of 0 or 1
a. ECOG PS of 2 may be eligible upon the review and approval of the Medical Monitor.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
300mg DKN-01 monotherapy in recurrent EEC
Drug: 300mg DKN-01
300mg DKN-01+paclitaxel in recurrent EEC
Drug: Paclitaxel · Drug: 300mg DKN-01
300mg DKN-01 monotherapy in recurrent EOC
Drug: 300mg DKN-01
300mg DKN-01+paclitaxel in recurrent EOC
Drug: Paclitaxel · Drug: 300mg DKN-01
600mg DKN-01 monotherapy in carcinosarcoma
Drug: 600mg DKN-01
600mg DKN-01 +paclitaxel in carcinosarcoma
Drug: Paclitaxel · Drug: 600mg DKN-01
Administered by IV infusion
Also known as: Taxol
Administered by IV infusion
Administered by IV infusion
Number of Subjects With Objective Response Rate (ORR) in EEC or EOC Patients
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Objective Response Rate (ORR) in Carcinosarcoma (MMMT) Patients
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Time frame: Baseline to study completion (approximately 6 months)
Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.
Time frame: Baseline to study completion (maximum 17.6 months)
Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
Time frame: Baseline to study completion (maximum 7.1 months)
Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.
Time frame: Baseline to study completion (approximately 11 months)
Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.
Time frame: Baseline to study completion (approximately 11 months)
Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.
Time frame: Baseline to study completion (approximately 13.1 months)
Number of Subjects With Response to Therapy in Patients With and Without Activating β-catenin Mutations and/or Wnt Signaling Genetic Alterations in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
Time frame: Baseline to study completion (approximately 6 months)
Dickkopf-1 (DKK1) Concentration in Serum and Plasma Relative to Safety and Efficacy Outcomes in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT).
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v5.0 of DKN-01 600 mg +/- Paclitaxel in Patients With Recurrent Carcinosarcoma (MMMT) in Carcinosarcoma (MMMT) Patients
Time frame: Baseline to study completion (approximately 6 months)
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline to study completion (approximately 6 months)
Maximum Plasma Concentration (Cmax)
Time frame: Baseline to study completion (approximately 6 months)
Time Taken to Reach the Maximum Plasma Concentration (Tmax)
Time frame: Baseline to study completion (approximately 6 months)
Area Under the Curve (AUC)
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Adverse Drug Reactions and Toxicities as Evaluated by NCI CTCAE v4.03 as DKN-01 as Monotherapy or in Combination With Paclitaxel in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
Time frame: Baseline to study completion (approximately 6 months)
Number of Subjects With Adverse Drug Reactions and Toxicities to Study Treatment Regimen in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT) as Evaluated by NCI CTCAE v5.0
Time frame: Baseline to study completion (approximately 6 months)
Concentration of DKN-01 Antibodies in Human Serum in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT)
Time frame: Baseline to study completion (approximately 6 months)
| Milestone | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600 mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Started | 29 | 24 | 14 | 19 | 1 | 8 | 4 | 12 |
| Completed | 26 | 21 | 13 | 19 | 1 | 8 | 4 | 10 |
| Not completed | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 2 |
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
| participants | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Recurrent EOC |
|---|---|---|---|---|
| ORR | 2 | 0 | 0 | 0 |
| Complete Response | 1 | 0 | 0 | 0 |
| Partial Response | 1 | 0 | 0 | 0 |
| Stable Disease | 9 | 12 | 6 | 13 |
| Progressive Disease | 15 | 9 | 7 | 6 |
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
| participants | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|
| Confirmed ORR | 0 | 0 | 1 | 1 |
| Complete Response | 0 | 0 | 0 | 0 |
| Partial Response | 0 | 0 | 1 | 1 |
| Stable Disease | 1 | 1 | 0 | 4 |
| Progressive Disease | 0 | 7 | 3 | 5 |
Objective Disease Control Rate (ODCR) was defined as the percentage of subjects with a Best Overall Response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm), Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters), or Stable Disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as Progressive Disease) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
| Participants | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Number of Subjects With Objective Disease Control Rate (ODCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | 11 | 12 | 6 | 13 | 1 | 1 | 1 | 5 |
Overall Survival (OS) is defined as the time from first dose of study drug until date of death due to any cause.
| months | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Overall Survival (OS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | 12.2 (4.6 to NA) | 10.1 (6.5 to 13.6) | 10.8 (5.7 to 17.6) | 11.9 (6.6 to NA) | NA (NA to NA) | 8.4 (1.3 to NA) | 7.3 (5.3 to NA) | 5.7 (1.6 to NA) |
Progression-free survival (PFS) is defined as time from first dose of study drug to first documentation of PD (per RECIST 1.1) or death due to any cause.
| months | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Progression-free Survival (PFS) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | 1.8 (1.7 to 5.5) | 3.8 (1.8 to 5.4) | 2.1 (1.6 to 3.5) | 3.6 (1.8 to 7.1) | 11.6 (NA to NA) | 1.6 (0.5 to 7.9) | 2.0 (1.8 to 5.5) | 1.9 (0.9 to 4.0) |
Duration of Response (DoR) includes only patients that have responded with an objective disease response (PR or CR) and is defined as the time from the first tumor assessment that supports the patient's objective disease response to the time of PD or death due to any cause.
| months | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Eecurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Duration of Response (DoR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | NA (NA to NA) | — | — | — | — | — | 3.7 (NA to NA) | NA (NA to NA) |
Number of participants analyzed only includes patients with a CR and is otherwise defined and analyzed similar to DoR.
| months | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinosarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Duration of Complete Response (DoCR) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | NA (NA to NA) | — | — | — | — | — | — | — |
Duration of Clinical Benefit (DoCB) includes patients with a Best Overall Response of CR, PR, or SD and is defined as the time from the first tumor assessment of CR, PR or SD to the time of PD or death due to any cause.
| months | DKN-01 Monotherapy in Recurrent EEC | DKN-01 + Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01 + Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg + Paclitaxel in Carcinsarcoma | DKN-01 600mg + Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Duration of Clinical Benefit (DoCB) in Patients With Recurrent EEC or EOC or Carcinosarcoma (MMMT). | 4.7 (1.2 to 9.2) | 3.8 (2.0 to 4.2) | 1.9 (1.7 to 13.1) | 3.9 (1.8 to 5.6) | NA (NA to NA) | 6.0 (NA to NA) | 3.7 (NA to NA) | 2.2 (1.9 to NA) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over The Safety Analysis Set is all subjects who received greater than or equal to 1 administration of assigned study treatment (DKN-01 or paclitaxel). Subjects were followed for treatment emergent adverse events (AE), defined as any AE with an onset or worsening of a pre-existing condition on or after the first dose of the study drug through 30 days following the last dose of study drug, up to approximately 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DKN-01 Monotherapy in Recurrent EEC | 14/29 (48.3%) | 8/29 (27.6%) | 29/29 (100%) |
| DKN-01+Paclitaxel in Recurrent EEC | 16/24 (66.7%) | 13/24 (54.2%) | 24/24 (100%) |
| DKN-01 Monotherapy in Recurrent EOC | 11/14 (78.6%) | 1/14 (7.1%) | 13/14 (92.9%) |
| DKN-01+Paclitaxel in Recurrent EOC | 12/19 (63.2%) | 6/19 (31.6%) | 19/19 (100%) |
| 300mg DKN-01 Monotherapy in Carcinosarcoma | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| 600mg DKN-01 Monotherapy in Carcinosarcoma | 4/8 (50%) | 2/8 (25%) | 8/8 (100%) |
| 300mg DKN-01+Paclitaxel in Carcinosarcoma | 2/4 (50%) | 0/4 (0%) | 4/4 (100%) |
| 600mg DKN-01+Paclitaxel in Carcinosarcoma | 8/12 (66.7%) | 6/12 (50%) | 12/12 (100%) |
| Event | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | 300mg DKN-01 Monotherapy in Carcinosarcoma | 600mg DKN-01 Monotherapy in Carcinosarcoma | 300mg DKN-01+Paclitaxel in Carcinosarcoma | 600mg DKN-01+Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/29 | 1/24 | 0/14 | 0/19 | 1/1 | 0/8 | 0/4 | 1/12 |
| Atrial fibrillationCardiac disorders | 0/29 | 0/24 | 0/14 | 0/19 | 0/1 | 1/8 | 0/4 | 0/12 |
| AscitesGastrointestinal disorders | 0/29 | 1/24 | 0/14 | 0/19 | 0/1 | 1/8 | 0/4 | 1/12 |
| Oedema peripheralGeneral disorders | 0/29 | 0/24 | 0/14 | 0/19 | 0/1 | 1/8 | 0/4 | 0/12 |
| Urinary tract obstructionRenal and urinary disorders | 0/29 | 0/24 | 0/14 | 0/19 | 0/1 | 1/8 | 0/4 | 0/12 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/29 | 1/24 | 0/14 | 0/19 | 0/1 | 1/8 | 0/4 | 0/12 |
| Small intestinal obstructionGastrointestinal disorders | 0/29 | 2/24 | 0/14 | 0/19 | 0/1 | 0/8 | 0/4 | 1/12 |
| Urinary tract infectionInfections and infestations | 1/29 | 0/24 | 0/14 | 0/19 | 0/1 | 0/8 | 0/4 | 1/12 |
| Catheter site cellulitisInfections and infestations | 0/29 | 0/24 | 0/14 | 0/19 | 0/1 | 0/8 | 0/4 | 1/12 |
| Upper respiratory tract infectionInfections and infestations | 0/29 | 0/24 | 0/14 | 0/19 | 0/1 | 0/8 | 0/4 | 1/12 |
| Event | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | 300mg DKN-01 Monotherapy in Carcinosarcoma | 600mg DKN-01 Monotherapy in Carcinosarcoma | 300mg DKN-01+Paclitaxel in Carcinosarcoma | 600mg DKN-01+Paclitaxel in Carcinosarcoma |
|---|---|---|---|---|---|---|---|---|
| ChillsGeneral disorders | 2/29 | 3/24 | 0/14 | 2/19 | 1/1 | 1/8 | 1/4 | 0/12 |
| PyrexiaGeneral disorders | 2/29 | 2/24 | 0/14 | 3/19 | 1/1 | 0/8 | 0/4 | 0/12 |
| BronchitisInfections and infestations | 1/29 | 0/24 | 0/14 | 0/19 | 1/1 | 0/8 | 0/4 | 0/12 |
| Procedural painInjury, poisoning and procedural complications | 2/29 | 2/24 | 0/14 | 0/19 | 1/1 | 0/8 | 1/4 | 1/12 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/29 | 4/24 | 2/14 | 3/19 | 1/1 | 1/8 | 0/4 | 1/12 |
| Back painMusculoskeletal and connective tissue disorders | 3/29 | 7/24 | 2/14 | 0/19 | 1/1 | 2/8 | 0/4 | 2/12 |
| PollakiuriaRenal and urinary disorders | 3/29 | 1/24 | 0/14 | 0/19 | 1/1 | 0/8 | 0/4 | 1/12 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/29 | 1/24 | 0/14 | 0/19 | 1/1 | 1/8 | 0/4 | 1/12 |
| AlopeciaSkin and subcutaneous tissue disorders | 0/29 | 8/24 | 0/14 | 8/19 | 1/1 | 0/8 | 1/4 | 0/12 |
| Deep vein thrombosisVascular disorders | 0/29 | 3/24 | 0/14 | 0/19 | 1/1 | 0/8 | 0/4 | 1/12 |
| Age, Categorical(Participants) | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg+Paclitaxel in Carcinosarcoma | DKN-01 600mg+Paclitaxel in Carcinosarcoma | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 12 | 5 | 10 | 1 | 2 | 2 | 8 | 59 |
| >=65 years | 10 | 12 | 9 | 9 | 0 | 6 | 2 | 4 | 52 |
| Sex: Female, Male(Participants) | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg+Paclitaxel in Carcinosarcoma | DKN-01 600mg+Paclitaxel in Carcinosarcoma | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 29 | 24 | 14 | 19 | 1 | 8 | 4 | 12 | 111 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg+Paclitaxel in Carcinosarcoma | DKN-01 600mg+Paclitaxel in Carcinosarcoma | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 7 |
| Not Hispanic or Latino | 25 | 23 | 14 | 18 | 1 | 7 | 4 | 10 | 102 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB)(Participants) | DKN-01 Monotherapy in Recurrent EEC | DKN-01+Paclitaxel in Recurrent EEC | DKN-01 Monotherapy in Recurrent EOC | DKN-01+Paclitaxel in Recurrent EOC | DKN-01 300mg Monotherapy in Carcinosarcoma | DKN-01 600mg Monotherapy in Carcinosarcoma | DKN-01 300mg+Paclitaxel in Carcinosarcoma | DKN-01 600mg+Paclitaxel in Carcinosarcoma | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 0 | 2 | 2 | 3 | 0 | 1 | 0 | 0 | 8 |
| White | 27 | 21 | 12 | 16 | 1 | 7 | 4 | 9 | 97 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Sep 2020, 30 months.
Results were first posted in Jun 2023, 2 years 9 months after primary completion.
Of 139 phase 2 interventional studies under Endometrial Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 115. This study's 30 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Paclitaxel · Sirexatamab
Leap Therapeutics, Inc.