Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DKN-01 · 6 trials · 20 indications
PFS, as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC.
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)
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)
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.03).
SUV as measured by NaF-PET/CT in both myeloma bone lesions and normal bone
Ki as measured by NaF-PET/CT in both myeloma bone lesions and normal bone
SUV as measured by FDG-PET/CT in both myeloma bone lesions and normal bone
Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.
Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.
For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | DKN-01 + FOLFIRI or FOLFOX + bevacizumab |
| Control | ACTIVE_COMPARATOR | FOLFIRI or FOLFOX + bevacizumab |
| DKN-01 monotherapy in recurrent EEC | EXPERIMENTAL | 300mg DKN-01 monotherapy in recurrent EEC |
| DKN-01+paclitaxel in recurrent EEC | EXPERIMENTAL | 300mg DKN-01+paclitaxel in recurrent EEC |
| DKN-01 monotherapy in recurrent EOC | EXPERIMENTAL | 300mg DKN-01 monotherapy in recurrent EOC |
| DKN-01+paclitaxel in recurrent EOC | EXPERIMENTAL | 300mg DKN-01+paclitaxel in recurrent EOC |
| DKN-01 monotherapy in carcinosarcoma | EXPERIMENTAL | 600mg DKN-01 monotherapy in carcinosarcoma |
| DKN-01 +paclitaxel in carcinosarcoma | EXPERIMENTAL | 600mg DKN-01 +paclitaxel in carcinosarcoma |
| 150 mg DKN-01 Part A | EXPERIMENTAL | Patients will receive 150 mg of DKN-01 followed by gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle. |
| 300 mg DKN-01 Part A | EXPERIMENTAL | Patients will receive 300 mg of DKN-01 followed by gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle. |
| MTD mg DKN-01 Part B | EXPERIMENTAL | Patients are treated at the maximum tolerated dose (MTD) of DKN-01 (or highest dose tested in Part A if the MTD is not defined) followed by gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 on Days 1 and 8 of each 21-day cycle. |
| DKN-01 150 mg plus paclitaxel | EXPERIMENTAL | DKN-01 150 mg administered on Days 1 and 15 and paclitaxel 80 mg per meter squared of body surface area (mg/m2) administered on Days 1, 8, 15, and 22 |
| DKN-01 300 mg plus paclitaxel | EXPERIMENTAL | DKN-01 300 mg administered on Days 1 and 15 and paclitaxel 80 mg per meter squared of body surface area (mg/m2) administered on Days 1, 8, 15, and 22 |
| DKN-01 150 mg plus pembrolizumab | EXPERIMENTAL | DKN-01 150 mg administered on Days 1 and 15 and pembrolizumab 200 mg administered on Day 1 |
| DKN-01 300 mg plus pembrolizumab | EXPERIMENTAL | DKN-01 300 mg administered on Days 1 and 15 and pembrolizumab 200 mg administered on Day 1 |
| DKN-01 300 mg monotherapy | EXPERIMENTAL | DKN-01 300 mg administered on Days 1 and 15 |
| DKN-01 300mg | EXPERIMENTAL | DKN-01 plus lenalidomide (Revlimid)/dexamethasone |
| DKN-01 600mg | EXPERIMENTAL | DKN-01 plus lenalidomide (Revlimid)/dexamethasone |
| Standard of Care | ACTIVE_COMPARATOR | Lenalidomide (Revlimid)/dexamethasone |
| 75 milligram (mg) DKN-01 Part A | EXPERIMENTAL | DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle. |
| 600 mg DKN-01 Part A | EXPERIMENTAL | DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle. |
| 300 mg DKN-01 Part B | EXPERIMENTAL | Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle. |
| Name | Type | Description |
|---|---|---|
| DKN-01 | DRUG | 30 minute IV infusion (400mg) every two weeks with an additional loading dose in the first cycle of treatment |
| FOLFIRI | DRUG | 90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks |
| Bevacizumab | DRUG | 90-min IV infusion (5mg) |
| FOLFOX | DRUG | 2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks |
| Paclitaxel | DRUG | Administered by IV infusion |
| 300mg DKN-01 | DRUG | Administered by IV infusion |
| 600mg DKN-01 | DRUG | Administered by IV infusion |
| gemcitabine | DRUG | Administered by IV infusion. |
| cisplatin | DRUG | Administered by IV infusion |
| DKN-01 150 mg | DRUG | Administered by IV infusion |
| Pembrolizumab | DRUG | Administered by IV infusion |
| DKN-01 300 mg | DRUG | Administered by IV infusion |
| DKN-01 600 mg | DRUG | 600 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone |
| Standard of Care | DRUG | Current approved standard of care |
Adult patients with advanced CRC with measurable disease (RECIST v1.1) who have radiographically progressed during or following one line of systemic treatment will be enrolled in the study. Inclusion Criteria: Patients meeting all of the following criteria will be considered eligible for study ent...
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DKN-01 is an investigational small molecule being developed for the treatment of several cancers, including colorectal cancer, multiple myeloma, esophageal neoplasms, carcinoma of the intrahepatic and extra-hepatic biliary system, and endometrial cancer. It is currently in clinical development and has not been approved by the FDA.
DKN-01 is being developed by Cypherpunk Technologies Inc., a biopharmaceutical company traded under the ticker CYPH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
DKN-01 is in Phase 1 and Phase 2 clinical trials. The drug is investigational and has not received FDA approval. Completed trials include Phase 1 studies in esophageal and biliary cancers, as well as Phase 2 studies in endometrial and colorectal cancers.
DKN-01 has been studied in several completed trials. NCT02013154 evaluated DKN-01 with paclitaxel or pembrolizumab in esophageal and gastric cancers. NCT02375880 tested DKN-01 with gemcitabine and cisplatin in biliary tract cancers. NCT03395080 assessed DKN-01 alone or with paclitaxel in endometrial and ovarian cancers. NCT05480306 studied DKN-01 in colorectal cancer.
DKN-01 is not known to be the same as any other drug. It is a distinct investigational small molecule being developed by Cypherpunk Technologies Inc. for multiple oncology indications.
DKN-01 has been studied in a range of cancers, including esophageal neoplasms, gastroesophageal junction adenocarcinoma, gastric adenocarcinoma, biliary system carcinomas, gallbladder cancer, endometrial cancer, ovarian cancer, and colorectal cancer. These studies were conducted in the United States, Germany, and South Korea.