TTX-030

P2, N=194, Active, not recruiting, Trishula Therapeutics, Inc. | Recruiting --> Active, not recruiting

HLA-DQ is an HLA class II molecule expressed on APCs. Patients were enrolled May 2020 to Feb 2022 and treated with standard dosing of G/nP (d1, 8, 15) and either TTX-030 40mg/kg followed by 20mg/kg every two weeks (n = 31) or TTX-030 every 2 weeks and budigalimab (anti-PD1 Ab) 500mg every 4 weeks (n = 28). TTX-030 combinations show promising clinical activity in 1L PDAC with HLA-DQhigh having marked benefit. A randomized phase 2 study (NCT06119217) is underway to further evaluate TTX-030 combination treatment based on HLA-DQ status in metastatic PDAC.

P1, N=185, Completed, Trishula Therapeutics, Inc. | Active, not recruiting --> Completed

P2, N=180, Recruiting, Trishula Therapeutics, Inc. | Not yet recruiting --> Recruiting | Initiation date: Dec 2023 --> Mar 2024

P2, N=180, Not yet recruiting, Trishula Therapeutics, Inc.

P1, N=56, Completed, Trishula Therapeutics, Inc. | Active, not recruiting --> Completed

P1, N=56, Active, not recruiting, Trishula Therapeutics, Inc. | Trial completion date: Dec 2022 --> Dec 2023

P1, N=56, Active, not recruiting, Trishula Therapeutics, Inc. | Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Nov 2022

The addition of nivolumab to chemotherapy has recently become the standard of care of 1st‑line (1L) treatment of locally advanced or metastatic (LA/M) gastric cancer but further improvements are needed. An expansion cohort of Study TTX‑030‑002 (ongoing, US and South Korea) is evaluating the safety and efficacy of the combination of TTX-030, budigalimab (anti-PD-1) and FOLFOX for the 1L treatment of patients (pts) with LA/M HER2− gastric/GEJ adenocarcinoma... Preliminary results indicate that the combination of TTX-030, budigalimab and FOLFOX exhibited promising efficacy as 1L treatment of LA/M gastric/GEJ cancer regardless of CPS status and has a manageable safety profile without evidence of excessive toxicities. To our knowledge, this represents the first report of an anti-CD39 antibody in combination with chemo-immunotherapy in gastric cancer. Updated clinical and biomarker data will be included in the final presentation.

P1, N=56, Active, not recruiting, Trishula Therapeutics, Inc. | Recruiting --> Active, not recruiting | N=100 --> 56

The allosteric mechanism of TTX-030 was confirmed via mapping the epitope to a region of CD39 distant from its active site, which suggests possible models for how potent inhibition is achieved. In summary, TTX-030 is a potent allosteric inhibitor of CD39 ATPase activity that is currently being evaluated in clinical trials for cancer therapy.