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- | Labvax 3(22)-23 - LabyRx Immuno / Oncology, Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma (clinicaltrials.gov) - Oct 12, 2023
P1/2, N=77, Recruiting, Sponsor: Tianhong Li
Phase classification: P1 --> P1/2 | N=10 --> 77 | Trial completion date: Sep 2027 --> Jan 2030 | Trial primary completion date: Sep 2023 --> Jan 2026
- Labvax 3(22)-23 - LabyRx Immuno / Oncology
Labyrinthin as a potential neoantigen for oncogene-driven and non-oncogene-driven lung adenocarcinomas (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1442;
RNA sequencing analysis of blood mononuclear cells of two pts enrolled in phase I trial revealed that LabVax 3(22)-23 and adjuvant GM-CSF treatment modulated the activity of immune cells and PD-1 pathway. Conclusions LAB is a promising cancer neoantigen for both oncogene-driven and non-oncogene-driven LUAD, which warrant further study.
- Labvax 3(22)-23 - LabyRx Immuno / Oncology, Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
A phase 1/2 open label study of LabVax 3(22)-23 and adjuvant GM-CSF alone or in combination with pembrolizumab in subjects with labyrinthin-positive adenocarcinomas (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_972;
If ?2 subjects have a DLT, then the study will proceed to phase 2 expansions of 18 participants in each cohort. In Cohort A, if ?2 LUAD patients respond, an additional 25 patients will be enrolled.
- Keytruda (pembrolizumab) / Merck (MSD)
Novel biomarker assays for detecting labyrinthin-positive adenocarcinomas for a phase I/II trial of peptide vaccine LabVax 3(22)-23 alone or in combination with pembrolizumab (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_416;
P1/2
Ongoing studies are validating these results with more patients with NGS data. Conclusions We have established IHC and RNA assays to identify patients with LAB-positive adenocarcinomas in the ongoing phase I/II study (UCDCC#296, NCT051013560) evaluating the safety and efficacy of the LAB vaccine in combination with pembrolizumab.
- Leukine (sargramostim) / Partner Therap
A first-in-human phase I trial of a novel peptide vaccine LabVax 3(22)-23 and adjuvant GM-CSF sargramostim in patients with refractory labyrinthin-expressing adenocarcinomas. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4677;
P1
Based on preclinical synergism with pembrolizumab, this dose and injection schedule will be tested in a phase II open label study of LabVax 3(22)-23 and GM-CSF in combination with pembrolizumab in patients with refractory lung adenocarcinomas and adenocarcinomas of all other tumor types. Clinical trial information: NCT051013560.
- Leukine (sargramostim) / Partner Therap
A first-in-human, phase I, open-label study of a novel cancer vaccine labvax 3(22)-23 and adjuvant GM-CSF in patients with advanced stage adenocarcinomas. (Available On Demand; 337b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1756;
P1
After completion of study treatment, patients are followed every 3 months for 1 year. Two patients are enrolled at the time of submission.
- | Labvax 3(22)-23 - LabyRx Immuno / Oncology, Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap
New P1 trial, Metastases: A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma (clinicaltrials.gov) - Oct 31, 2021
P1, N=10, Recruiting, Sponsor: Tianhong Li