TAC100-HER2

P1/2, N=30, Terminated, Triumvira Immunologics, Inc. | N=110 --> 30 | Trial completion date: Jun 2027 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Dec 2023; Study terminated by Sponsor for commercial reasons

P1/2, N=110, Active, not recruiting, Triumvira Immunologics, Inc. | Recruiting --> Active, not recruiting

This patient had progressed on 4 prior lines of therapy including trastuzumab and trastuzumab deruxtecan... Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. The recommended phase 2 dose was identified as dose level 4 (6-8 x 106 cells/kg). Clinical trial information: NCT04727151.

This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan. Conclusions Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. The recommended phase 2 dose was identified as dose level 4 (6–8 x 106 cells/kg).

No abstract available

P1/2, N=110, Recruiting, Triumvira Immunologics, Inc. | N=70 --> 110 | Trial completion date: Feb 2025 --> Jun 2027 | Trial primary completion date: Nov 2024 --> Jun 2025

This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan. Conclusions Treatment with TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population. Dose escalation is complete.

This patient had progressed on 4 prior lines of therapy including trastzumab and trastuzumab deruxtecan... Treatment with the novel T cell therapy, TAC01-HER2 showed manageable safety and promising clinical activity in a heavily pre-treated cancer population, refractory to prior HER2 targeted treatments, including a complete reduction of target lesions in one patient. Dose escalation of TAC01-HER2 is ongoing.

Dose escalation of TAC01-HER2 is ongoing, with seven subjects treated and three more scheduled in Cohort 4. These results in a heavily pre-treated cancer population show manageable safety and promising clinical activity with a novel T cell therapy that may have broad clinical applicability in HER+ cancers. Clinical trial information: NCT04727151.

In phase I dose escalation, the primary objective is to evaluate the safety of TAC01-HER2 at increasing doses of 0.3, 0.8, 3, and 8 x 106 cells/kg in HER2+ solid tumors (1+, 2+ or 3+ as identified by immunohistochemistry) in adult subjects who have progressed after ≥2 lines of systemic therapy. Dose limiting toxicities (DLTs) are assessed up to 28 days from cell infusion. In Phase II, dose expansion groups will further evaluate the safety, efficacy, and pharmacokinetics of the optimal TAC01-HER2 dose in HER2+ breast and other solid tumor types.

TAC01-HER2, a first-in-class, autologous TAC T cell product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors... The in vitro and in vivo data confirm strong and specific activity of HER2-targeted TAC γδ T cells against HER2-expressing tumor models and highlights the potential of the TAC platform in the development of an allogeneic product for therapeutic applications in solid tumors.

Dose escalation of TAC01-HER2 is ongoing, with the first subject being treated at DL 3. These results in a heavily pre-treated gastrointestinal cancer population show manageable safety and promising efficacy with a novel T cell therapy that may have broad clinical applicability in HER+ cancers. Clinical trial information: NCT04727151.

Continued dose escalation of TAC01-HER2 is ongoing. Following completion of each dose level, a Data Safety Monitoring Committee has met to review all AEs to approve or deny escalation to the next highest dose level

As of 13 Apr 2022, 3 patients have been treated in Cohort 1 (0.3 x 10 6 cells/kg): rectosigmoid, gastro-esophageal, and gastric adenocarcinoma. No DLTs, CRS, or neurotoxicity events have been reported, with the Data Safety Monitoring Committee recommending commencement of patient enrollment in Cohort 2.

TAC01-HER2 is an autologous T-cell product comprising T cells expressing the HER2 TAC, a chimeric receptor that is genetically engineered into T cells via lentiviral transduction to furnish T cells with two main functions: redirection to and specific recognition of HER2-positive cells, and T cell activation via the endogenous TCR...After study completion, subjects are followed for survival and long-term safety for up to 15 years. The trial opened in January 2021 and it is actively enrolling pts.

Based on this preclinical pharmacology and toxicology data, TAC01-HER2, a first-in-class TAC T product targeting HER2 (ERBB2), has entered a phase I/II clinical trial in patients with HER2-positive solid tumors. The in vitro and in vivo data confirm strong and specific activity of CLDN18.2-targeted TAC T cells against CLDN18.2-expressing solid tumor models and highlight the versatility of the TAC platform for therapeutic applications in solid tumors.

TAC01-HER2, a first-in-class TAC T product targeting HER2 (ERBB2), has recently entered a phase I/II clinical trial in patients with HER2-positive solid tumors. Intravenous administration of CLDN18.2-TAC T cells in mice carrying CLDN18.2-positive tumor xenografts led to a sustained anti-tumor response. Conclusions The in vitro and in vivo data confirm strong and specific activity of CLDN18.2-targeted TAC T cells against CLDN18.2-expressing cancer cells and highlight the versatility of the TAC platform for therapeutic applications in solid tumors.

P1/2, N=70, Recruiting, Triumvira Immunologics, Inc. | Not yet recruiting --> Recruiting

P1/2, N=70, Not yet recruiting, Triumvira Immunologics, Inc.