Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CEND-1 · 3 trials · 5 indications
Adverse events (AEs), serious adverse events (SAEs), treatment related adverse events are included. The investigator should carry out judgment for investigational drug correlation.
Objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), progress-free survival (PFS), PFS rate, OS rate etc. are included.
Adverse Events : Counts and proportions of grade 3 -5 Adverse Events
Safety and toxicity profile of treatment regimen as measured by grade and frequency of adverse events, graded and documented according to the NCI CTCAE, version 5.0 guidelines
OBD will be determined by evaluating biomarkers (such as the tumor marker CA19-9 Response Rate), the ECOG Performance Status and the Disease Control Rate
| Arm | Type | Description |
|---|---|---|
| CEND-1 | EXPERIMENTAL | CEND-1+paclitaxel (albumin-bound type)+gemcitabine |
| Cohort 1 Pancreatic Cancer | EXPERIMENTAL | Biopsy for tissue immune profile if archived tissue not available. Folfirinox infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus CEND-1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery. |
| Cohort 2 Peritoneal Mets | EXPERIMENTAL | Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND-1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery. |
| Cohort 3 Oligomets Colon Cancer | EXPERIMENTAL | Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND-1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery. |
| Part A (Dose Escalation) | EXPERIMENTAL | Safety of ascending dose levels of CEND-1 in combination with gemcitabine and nab-paclitaxel will be evaluated. Patients will receive an IV bolus of CEND-1 on Day 1 of the 1-week run-in period. This is followed by one treatment cycle (28 days) with the CEND-1 / nab-paclitaxel (125mg/m\^2) / gemcitabine (1000mg/m\^2) combination given on Days 1, 8, 15. |
| Part B (Expansion) | EXPERIMENTAL | Safety and early efficacy of CEND-1 in combination with nab-paclitaxel (125mg/m\^2) and gemcitabine (1000mg/m\^2) will be evaluated (dosing on Days 1, 8, 15 of the 28-day treatment cycle). Treatment cycles will be repeated every 4 weeks based on toxicity and response. Treatment may continue as long as there is perceived benefit or until disease progression. |
| Name | Type | Description |
|---|---|---|
| CEND-1 | DRUG | The dose is specified according to the protocol. CEND-1+paclitaxel (albumin-bound type)+gemcitabine |
| Panitumumab | DRUG | Up to ten (10) participants with cancer that has spread to certain areas of the body and who have a certain gene in the tumor called "RAS/BRAF wild type" will receive another drug called panitumumab in addition to CEND-1 and FOLFIRINOX. |
| Folfirinox | DRUG | FOLFIRINOX is a name for a chemotherapy treatment regimen that includes several different drugs that are given in a certain order. All of these drugs are given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle). * Oxaliplatin - dose is 85 mg / m2 the infusion takes about 2 hours. then * Leucovorin - dose is 400 mg / m2 - this is given at same time with irinotecan (below) and the infusion takes about 1.5 hours. * Irinotecan - dose is 180 mg / m2 - this is given at same time with leucovorin (above), and the infusion takes about 1.5 hours. then • Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home. |
| Nab-paclitaxel | DRUG | Nab-paclitaxel will be provided as solution to be administered via IV infusion. |
| Gemcitabine | DRUG | Gemcitabine will be provided as solution to be administered via IV infusion. |
Inclusion Criteria: * Age: 18 to 80 years old, male or female. * Patients with histologically confirmed metastatic pancreatic ductal adenocarcinoma; * The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1. * The life expectancy is no less than 12 weeks. * According to the RECIST v1.1 evalua...
CEND-1 is an investigational small molecule being studied for the treatment of colon cancer and pancreatic cancer, including pancreatic ductal adenocarcinoma. It is being evaluated in combination with other therapies, such as nab-paclitaxel and gemcitabine, and with FOLFIRINOX regimens. CEND-1 is not yet approved and remains in clinical development.
CEND-1 is being developed by Lisata Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol LSTA. The company is conducting clinical trials of CEND-1 in oncology indications, including pancreatic and colon cancers.
CEND-1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are being conducted in patients with advanced metastatic pancreatic ductal adenocarcinoma and in combination with neoadjuvant FOLFIRINOX for digestive cancers.
CEND-1 has been studied in three clinical trials. NCT03517176 evaluated CEND-1 with nab-paclitaxel and gemcitabine in metastatic pancreatic cancer in Australia. NCT05052567 tested CEND-1 injection in advanced metastatic pancreatic ductal adenocarcinoma in China. NCT05121038 is an active trial in the United States combining CEND-1 with neoadjuvant FOLFIRINOX with or without panitumumab.
Yes, CEND-1 is also known as QLC12102. In clinical trial NCT05052567, the drug is referred to as CEND-1 Injection (QLC12102), confirming that QLC12102 is an alternative name for the same investigational agent.