Approval Probability
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Also known as iRGD, LSTA1, certepetide
CEND-1 · 4 trials · 13 indications
The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
Adverse Events : Counts and proportions of grade 3 -5 Adverse Events
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.
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 |
|---|---|---|
| LSTA1 arm for Untreated Cholangiocarcinoma | EXPERIMENTAL | - |
| LSTA1 arm for Second-Line Cholangiocarcinoma | EXPERIMENTAL | - |
| Placebo arm for Untreated Cholangiocarcinoma | PLACEBO_COMPARATOR | - |
| Placebo arm for Second-Line Cholangiocarcinoma | PLACEBO_COMPARATOR | - |
| 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. |
| CEND-1 | EXPERIMENTAL | CEND-1+paclitaxel (albumin-bound type)+gemcitabine |
| 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 |
|---|---|---|
| certepetide | DRUG | LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given |
| Durvalumab | DRUG | 1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles |
| Cisplatin | DRUG | cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles |
| Gemcitabine | DRUG | gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles |
| FOLFOX regimen | DRUG | The following will be given every 14 days: * oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion * fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes * fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump) |
| Placebo | DRUG | Placebo given as a slow IV push over 1 minute when standard treatment(s) are given |
| CEND-1 | DRUG | The treatment with CEND-1 will be 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 starting in Cycle 4). |
| 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. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥ 3 months * At least one measurable lesion as assessed by RECIST 1.1 * Adequate organ and marrow function * Adequate contraception * Patients with either of the following: * Pathologic...
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CEND-1 is an investigational small molecule being studied in oncology for the treatment of pancreatic cancer and colon cancer. It is being developed as a combination therapy added to standard chemotherapy regimens, including FOLFIRINOX and nab-paclitaxel plus gemcitabine, in patients with advanced or metastatic disease.
CEND-1 is being developed by Lisata Therapeutics, Inc., which trades under the ticker LSTA. Lisata is the sponsor of the clinical program evaluating CEND-1 in pancreatic cancer and colon cancer, including studies conducted in the United States, China, and Australia.
CEND-1 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. Its clinical program includes completed and active Phase 1 trials in metastatic pancreatic cancer and in colon cancer, with a total of 80 patients enrolled across the studies.
CEND-1 has been studied in three Phase 1 trials. NCT05121038 is an active Phase 1 study of CEND-1 with neoadjuvant FOLFIRINOX with or without panitumumab in colon, pancreas, and digestive cancers in the United States. NCT05052567 and NCT03517176 evaluated CEND-1 in pancreatic cancer in China and Australia.
CEND-1 is studied as an add-on to chemotherapy. NCT05121038 combines CEND-1 with neoadjuvant FOLFIRINOX, with or without panitumumab, in colon and pancreatic cancers. NCT03517176 combined CEND-1 with nab-paclitaxel and gemcitabine in metastatic pancreatic cancer, and NCT05052567 evaluated CEND-1 injection in metastatic pancreatic ductal adenocarcinoma.
Across the CEND-1 Phase 1 program, 80 patients have been enrolled in total. NCT05121038 enrolled 50 patients, NCT05052567 enrolled 50 patients, and NCT03517176 enrolled 30 patients. All trials enrolled adults aged 18 years and older and were open to all sexes.