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Program Status Clinical trial’s patient recruitment status
Phase Phase of the clinical trial that is recruiting (I, II, or III)
Prior Immunotherapy Allowed Whether the clinical trial is open to patients who have received prior immunotherapy
CRC-directed Trial A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Drugs Therapeutics used in the clinical trial
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Therapeutic vaccine for patients with solid tumors with certain types of KRAS or NRAS mutant variants: G12D, G12R, G12V, G12A, G12C, G12S, G13D. Key inclusion criteria: for patients with a CT scan that shows no evidence of recurrent disease but who have positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable.
ELI-002 2P is a tumor vaccine comprised of a lymph-node targeted amphiphile (AMP)-modified G12D and G12R mutant KRAS peptides together with an AMP-modified CpG oligonucleotide adjuvant. Preliminary antitumor activity in KRAS mutated pancreatic ductal adenocarcinoma. UPDATE February 2024: Results regarding CRC and other solid tumors from the phase 1 dose escalation study (AMPLIFY-201, NCT04853017):
“The phase 1 trial involved 25 patients whose pancreatic or colorectal cancer had G12D and G12R KRAS mutations and were at high risk of the cancer returning after surgery. The results demonstrated this vaccine is safe and appears to stimulate the patient’s immune system to create cancer-fighting cells:
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Inclusion Criteria
Inclusion Criteria:
* KRAS/NRAS mutated (G12D, G12R, G12V, G12A, G12C, G12S, G13D) solid tumor * Phase 1 only: positive for circulating tumor DNA and/or elevated serum tumor biomarkers (such as CA19-9 and CEA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable * Screening CT is negative for recurrent disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
Exclusion Criteria:
* Presence of tumor mutations where specific therapy is approved * Known brain metastases * Use of immunosuppressive drugs
NCT ID Trial ID number from clinicaltrials.gov or other database
Date Trial Added Date on which the clinical trial was added to the clinicaltrials.gov website
Updated Date Date on which the clinical trial was updated on the clinicaltrials.gov website