TAC01-HER2, an autologous TAC-T cell lead asset made to target HER2 in relapsed or refractory gastric and gastroesophageal junction tumors, is being further evaluated in phase 2 of the TACTIC-2 study.
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Trial Name: A Phase 1/2 Trial Investigating the Safety and Efficacy of Autologous TAC T Cell Monotherapy, and TAC T Cells in Combination With Pembrolizumab, in Relapsed HER2-Positive Solid Tumors
ClinicalTrials.gov Identifier: NCT04727151
Sponsor: Triumvira Immunologics, Inc.
Recruitment Contact: Kara Moss, (512) 646-4516, patient.info@triumvira.com
Completion Date: June 2027
The first patient with relapsed or refractory HER2-positive gastric and gastroesophageal junction (GEJ) tumors has been dosed with TAC01-HER2 in phase 2 of the phase 1/2 TACTIC-2 (NCT04727151) study.1
TAC01-HER2 is an autologous TAC-T cell lead asset being developed to target HER2 in relapsed or refractory gastric and GEJ tumors. The novel cell therapy is based on genetically engineered autologous T cells expressing a T-cell antigen coupler which recognizes HER2.
“If this technology works, obviously I am optimistic, this also opens the door for a myriad of targets, things that we know we want to go after, but we're afraid to do with a [chimeric antigen receptor] T. It also opens the door to cellular therapy for older and less fit individuals,” said Benjamin L. Schlechter, senior physician at Dana-Farber Cancer Institute and instructor in Medicine at Harvard Medical School, in an interview with Targeted OncologyTM.
"This marks a significant milestone for our company, building upon the determination of the recommended phase 2 dose, identifying gastric and gastroesophageal cancer patients as targets for the phase 2 registration supporting study, and the positive benefit we observed during the phase 1 part of TACTIC-2," said Deyaa Adib, MD, chief medical officer of Triumvira Immunologics, in a press release.
Previously, initial data from the TACTIC-2 study showed that TAC01-HER2 was well-tolerated and demonstrated early signals of clinical activity in patients with HER2-positive solid tumors.2 Encouraging safety data were seen in patients treated with TAC01-HER2 as a monotherapy, as well as in combination with pembrolizumab (Keytruda), and no dose limiting toxicities, cytokine release syndrome, or immune effector cell-associated neurotoxicity were seen. Further, all serious adverse events were confirmed to be unrelated to TAC01-HER2.
In the open-label, multicenter, phase 1/2 TACTIC-2 study, investigators are evaluating the safety and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab in patients with HER2-positive gastric and GEJ adenocarcinoma.3
The phase 1 portion of the first-in-human study is investigating the safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetics (PK), and efficacy of TAC01-HER2 in patients with HER2-positive solid tumors who have been treated afterwith at least 2 lines of previous therapy. In the second phase of the study, patients will be those who have been treated with at least 2 lines of prior therapy, but no more than 4 lines.
In phase 1, patients were given escalating doses of TAC01-HER2, and in phase 2, dose-expansion groups will further evaluate the efficacy, safety, and PK of the MTD or RP2D for TAC01-HER2 in this patient population.
Phase 2 of the study is utilizing a Simon 3-stage design. Up to 36 patients will be enrolled in the monotherapy arm (group A) and 34 patients will be included in the combination arm (group B).
In the second phase, primary end points include overall response rate, duration of response, overall survival, disease control rate, and progression-free survival. Secondary end points of phase 2 include safety, tolerability, and PK.
Patients are actively being recruited for the study in Illinois, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, Texas, and Canada. The study has an estimated completion date of June 2027.
"Despite considerable advances in the oncology field, HER2-positive gastric and gastro-esophageal cancers remain difficult to treat, and new therapeutic options are urgently needed especially in later treatment lines in a growing patient segment. Our TAC technology offers a novel approach that works by leveraging the natural signaling pathways of endogenous TCRs and modifying T cells into TAC T cells with demonstrated success in the treatment of these tumors. We are committed to providing clinically meaningful therapeutic benefits to this patient population with high unmet medical needs," said Adib.1
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