ELI-002 for Colorectal Cancer
(AMPLIFY-7P Trial)
Recruiting in Palo Alto (17 mi)
+27 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Elicio Therapeutics
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment called ELI-002 7P for patients with specific types of cancer. The treatment helps the immune system recognize and attack these cancer cells. ELI-002 7P targets mutations that are common in various cancers and have been studied for their role in tumor growth and resistance to treatments.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot use immunosuppressive drugs.
What data supports the idea that ELI-002 for Colorectal Cancer is an effective treatment?
The available research does not provide any data on the effectiveness of ELI-002 for Colorectal Cancer. Instead, the studies focus on treatments for prostate cancer, specifically castration-resistant prostate cancer, and do not mention ELI-002 or its effectiveness for colorectal cancer or any other condition.
12345What safety data is available for ELI-002 in colorectal cancer treatment?
The provided research does not contain specific safety data for ELI-002, ELI-002 7P, or ELI-002 2P in the context of colorectal cancer treatment. The studies mentioned focus on other chemopreventive drugs and strategies, such as low-dose aspirin, COX-2 inhibitors, and dietary interventions, but do not address ELI-002 or its variants.
678910Eligibility Criteria
This trial is for people with certain solid tumors that have specific KRAS/NRAS mutations. They should show no signs of recurring disease on a CT scan, and some may need to have tumor DNA or high levels of cancer markers after standard treatments. It's not for those with treatable mutations, brain metastases, or who are taking immunosuppressive drugs.Inclusion Criteria
The CT scan does not show any signs of the disease coming back.
I am fully active or can carry out light work.
My solid tumor has a specific KRAS/NRAS mutation.
+1 more
Exclusion Criteria
I have cancer that has spread to my brain.
I am currently taking drugs that suppress my immune system.
My tumor has mutations that can be treated with approved drugs.
Participant Groups
The study tests ELI-002 7P immunotherapy in patients with mutated KRAS/NRAS solid tumors. This treatment combines an immune-stimulating molecule (Amph-CpG-7909) with lipid-conjugated peptides (Amph-Peptides 7P), aiming to boost the body's defense against cancer cells.
4Treatment groups
Experimental Treatment
Group I: Phase 2 randomized: ELI-002 7PExperimental Treatment1 Intervention
The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
Group II: Phase 1B: ELI-002 7PExperimental Treatment1 Intervention
The ELI-002 7P dose selected during the Phase 1A portion of the study will be administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
Group III: Phase 1A: ELI-002 7P (Low Peptide dose)Experimental Treatment1 Intervention
ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (1.4mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
Group IV: Phase 1A: ELI-002 7P (High Peptide dose)Experimental Treatment1 Intervention
ELI-002 Amph-CpG-7909 (10.0mg) admixed with ELI-002 Amph-Peptides 7P (4.9mg) administered via SC injection weekly for 4 consecutive weeks, followed by bi-weekly injections over 4 weeks, during the Immunization Period; additional SC injections for 4 consecutive weeks during the Booster Period (the two periods are separated by 2 months of no dosing)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiCoral Gables, FL
Emory Winship Cancer InstituteAtlanta, GA
University of Texas SouthwesternDallas, TX
Medical College of WisconsinMilwaukee, WI
More Trial Locations
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Who Is Running the Clinical Trial?
Elicio TherapeuticsLead Sponsor
References
[ARV-7: A biomarker for the treatment of metastatic castration-resistant prostate cancer]. [2020]As more and more patients with metastatic prostate cancer develop resistance to androgen-deprivation therapy (ADT) and consequently castration-resistant prostate cancer (CRPC), reasonable selection of therapies is becoming increasingly important for the prediction of the therapeutic results. Many studies show that androgen receptor splice variant 7 (AR-V7) is involved in the development and progression of CRPC and that the expression of AR-V7, absolutely higher in CRPC than in hormone-nave prostate cancer, plays a significant role in the mechanisms of resistance to abiraterone, enzalutamide and taxane chemotherapies. Further more, some clinical trials have revealed that the AR-V7 level may indicate the prognosis of different therapeutic options: AR-V7 negative in circulating tumor cells suggesting the effectiveness of a new hormonal therapy and taxane chemotherapy while AR-V7 positive indicating the poor result of a new hormonal therapy. These findings show that AR-V7 could be a biomarker for therapeutic options and the prognostic evaluation of CRPC.
Optimal timing of chemotherapy in androgen independent prostate cancer. [2018]To interpret available docetaxel clinical trial data in order to define optimal timing of the initiation of chemotherapy in androgen independent prostate cancer (AIPC).
Clinical Significance of Androgen Receptor Splice Variant-7 mRNA Detection in Circulating Tumor Cells of Men With Metastatic Castration-Resistant Prostate Cancer Treated With First- and Second-Line Abiraterone and Enzalutamide. [2022]Purpose We reported previously that the detection of androgen receptor splice variant-7 (AR-V7) mRNA in circulating tumor cells (CTCs) correlated with poor outcomes from the use of abiraterone and enzalutamide in patients with castration-resistant prostate cancer (CRPC). Here, we expanded our cohort size to better characterize the prognostic significance of AR-V7 in this setting. Methods We prospectively enrolled 202 patients with CRPC starting abiraterone or enzalutamide and investigated the prognostic value of CTC detection (+ v -) and AR-V7 detection (+ v -) using a CTC-based AR-V7 mRNA assay. We examined ≥ 50% prostate-specific antigen (PSA) responses, PSA progression-free survival, clinical and radiologic progression-free survival, and overall survival. We constructed multivariable models adjusting for PSA, Gleason sum, number of prior hormone therapies, prior abiraterone or enzalutamide use, prior taxane use, presence of visceral metastases, and Eastern Cooperative Oncology Group score. We also separately examined the first-line and second-line novel hormonal therapy (NHT) settings. Results Median follow-up times were 15.0, 21.7, and 14.6 months for CTC-, CTC+/AR-V7- and CTC+/AR-V7+ patients, respectively. CTC+/AR-V7+ patients were more likely to have Gleason scores ≥ 8 ( P = .05), metastatic disease at diagnosis ( P = .01), higher PSA ( P
Can docetaxel therapy improve overall survival from primary therapy compared with androgen-deprivation therapy alone in Japanese patients with castration-resistant prostate cancer? A multi-institutional cooperative study. [2022]To verify the actual clinical benefit of docetaxel (DOC) therapy and to explore the prognostic factors that may predict overall survival in Japanese patients with castration-resistant prostate cancer (CRPC).
Prolonged treatment with three-weekly docetaxel plus daily prednisolone for metastatic castration-resistant prostate cancer: a multicenter, phase II, open-label, non-comparative, extension study in Japan. [2022]There are few reports of long-term treatment with docetaxel in castration-resistant prostate cancer (CRPC) because of the limit of a maximum of ten cycles of treatment in TAX327 showing a survival benefit. Therefore, this study, ARD6563, was conducted to evaluate the safety of more than ten cycles of docetaxel in metastatic CRPC.
Chemoprevention of colorectal cancer in Japan: a brief introduction to current clinical trials. [2021]The rapidly increasing incidence of colorectal cancer in Japan poses a great challenge to researchers to develop preventive strategies against this disease. Thus far, several clinical trials for this purpose have been planned in Japanese subjects; some have been completed and documented while others are still ongoing. Also, the Ministry of Health, Labour and Welfare of Japan recognizes the significance of cancer prevention studies, especially against colorectal cancer, including it as one of the pillars in the "Third Research Project on General Strategies against Cancer" and funding several large-scale projects. Among them are two chemoprevention studies currently being performed: in patients with previous sporadic colorectal tumors (J-CAPP study) and in patients with familial adenomatous polyposis (J-FAPP study II). Both are double-blind randomized controlled trials with low-dose aspirin (100 mg/day), which is generally considered to be safe for long-term use. This article outlines relevant past clinical data and gives a brief introduction to these two studies.
Current chemoprevention approaches in Lynch syndrome and Familial adenomatous polyposis: a global clinical practice survey. [2023]Label="Background" NlmCategory="UNASSIGNED">International chemoprevention preferences and approaches in Lynch syndrome (LS) and APC-associated polyposis, including Familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) have not been previously explored.
Chemoprevention of colorectal cancer. [2022]Colorectal cancer has become one of the most prevalent malignant diseases for both men and women. Patients with inflammatory bowel diseases or certain inherited cancer syndromes are at high risk of developing colorectal cancer and have naturally the highest need for cancer prevention. In familial adenomatous polyposis (FAP) and Lynch syndrome, most of the underlying germline mutations can be detected by DNA sequencing, and medical counselling of affected individuals involves both surveillance tests and chemopreventive measures. However, as the mechanisms leading to colorectal cancer differ in these high-risk groups, the molecular action of chemopreventive drugs needs to be adjusted to the certain pathway of carcinogenesis. In the last decades, a number of drugs have been tested, including sulindac, aspirin, celecoxib, and mesalazine, but some of them are still controversially discussed. This review summarizes the advances and current standards of colorectal cancer prevention in patients with inflammatory bowel disease, FAP and Lynch syndrome.
Does a selective cyclooxygenase-2 inhibitor (tiracoxib) induce clinically sufficient suppression of adenomas in patients with familial adenomatous polyposis? A randomized double-blind placebo-controlled clinical trial. [2021]There have been few placebo-controlled randomized double-blind studies of the clinical effects of selective cyclooxygenase-2 (COX-2) inhibitors on the regression of colorectal tumors. This study was designed to examine the regressive effect of a selective COX-2 inhibitor, tiracoxib (JTE-522), on colorectal polyps in patients with familial adenomatous polyposis (FAP), and its safety.
Dietary-induced ERbeta upregulation counteracts intestinal neoplasia development in intact male ApcMin/+ mice. [2010]Most sporadic colorectal cancers (CRCs) develop through the adenoma-carcinoma sequence pathway and are initiated by adenomatous polyposis coli (APC) gene mutations. Estrogen receptor beta (ERbeta) is recognized to progressively reduce its expression in adenomatous and carcinomatous tissues in humans. Moreover, ERbeta deficiency enhances small intestinal tumorigenesis in rodents. In the Apc(Min/+) mouse model, we evaluated intestinal polyp development and ERbeta expression plus other biological parameters influencing tumor growth (epithelial cell proliferation, apoptosis and migration) following the addition of a combination of the ERbeta-selective agonist silymarin (SIL) and/or lignin (LIG) to a high-fat/low-fiber diet. Forty-five Apc(Min/+) mice were divided in four groups: animals fed on the tumorigenic high-fat/low-fiber diet, the tumorigenic diet supplemented with SIL (0.02%) or purified LIG (6.24%) or SIL (0.005%) + LIG (6.24%). In these animals, we assessed polyp number and volume and their degree of dysplasia together with ERbeta messenger RNA (mRNA) and protein levels and epithelial cell proliferation, migration and apoptosis. The latter group of parameters was evaluated in normal and adenomatous mucosa and the results compared with those found in wild-type (WT) mice fed on the control diet. The addition of SIL or LIG to the diet and even more the specific combination of the two significantly counteracted intestinal tumorigenesis and increased ERbeta mRNA and protein levels. Cell proliferation and apoptosis were rebalanced and cell migration accelerated, restoring values similar to those observed in WT animals. Our results further support a protective effect of ERbeta in CRC suggesting the use of the combination of SIL-LIG as a potential approach against CRC development.
[Combined treatment of colorectal cancer followed by metastatic liver injury]. [2019]To increase the effectiveness of treatment of colorectal cancer followed by metastatic liver lesion.
Effects of tyrosine kinase inhibitor E7080 and eNOS inhibitor L-NIO on colorectal cancer alone and in combination. [2021]To investigate the effects of E7080 and N (5)-(1-iminoethyl)-L-ornithine dihydrochloride (L-NIO) on colorectal cancer alone and in combination.
Postoperative chemotherapy improves survival in patients with resected high-risk Stage II colorectal cancer: results of a systematic review and meta-analysis. [2021]The aim was to assess the benefit of adjuvant chemotherapy in high-risk Stage II colorectal cancer.
The number of high-risk factors is related to outcome in stage II colonic cancer patients. [2011]A subgroup of stage II colonic cancer patients are considered to be at high-risk for recurrent/metastatic disease based on 1) tumour obstruction/perforation 2)
Risk factors for the recurrence of stage II perforated colorectal cancer: A retrospective observational study. [2022]Patients with perforated colorectal cancer (PCRC) experience higher recurrence rates than those with non-perforated tissue. We identified the promoting factors of stage II PCRC recurrence after R0 surgery.