Combination treatment with IMX-110 and tislelizumab yields no dose-limiting toxicities thus far in the first cohort of patients with advanced/metastatic colorectal cancer in the phase 1b/2a IMMINENT-01 trial.
Investigational agent IMX-110 plus tislelizumab resulted in tumor shrinkage at 2 months in patients with advanced metastatic colorectal cancer (CRC), according to a press release on interim data from the phase 1b/2a IMMINENT-01 trial.
As of the data cutoff date of April 14, 2023, there was a 100% tumor shrinkage rate in the first 2 evaluable patients 2 months after they received the lowest dose of IMX-110. Additionally, investigators reported no dose-limiting toxicities in the first cohort, permitting them to enroll the next cohort of 3 patients who will receive a higher dose of IMX-110 in combination with tislelizumab.
“We are excited to see 100% tumor shrinkage in the very first cohort at the lowest dose of IMX-110 in combination with anti–PD-1 antibody tislelizumab in our ongoing IMMINENT-01 dose escalation trial, especially in patients with advanced [CRC], who have limited treatment options,” Ilya Rachman, MD, PhD, chief executive officer of ImmixBio, said in the press release. “These initial results potentially validate the scientific rationale for the promise of IMX-110 to unlock our immune system’s ability to fight cancer.”
In the phase 1b portion of the trial, patients will receive escalating doses of IMX-110 until investigators identify the maximum tolerated dose and the recommended phase 2 dose (RP2D). In phase 2a, an expected total of 30 patients with certain solid tumor indications selected based on data from phase 1b will receive treatment.
The primary end points of the IMMINENT-01 trial include determining the treatment-related adverse effects (TRAEs), the maximum tolerated dose, and the RP2D. Secondary end points include the plasma concentration of IMX-110, the objective response rate, progression-free survival, overall survival, and duration of response.
Patients 16 years and older with confirmed advanced solid tumors that have progressed and are refractory or intolerant to standard therapy are eligible for enrollment on the trial. Additional eligibility criteria includes having an ECOG performance status of 0 to 2, a life expectancy of at least 3 months, adequate cardiac function, and not having reached a cumulative total lifetime maximum dose of 550 mg/m2 of doxorubicin per investigator’s discretion.
Patients with a history of severe allergic reactions to any unknown allergens or components of the study regimen or are receiving any chemotherapy within 14 days of dosing, immunotherapy within 28 days of dosing, or biologic or hormonal therapy within 28 days of dosing are not eligible for enrollment. Patients are also unsuitable for enrollment if they are expected to need surgery during the study period, have a history of and/or risk factors of ischemic heart disease or congestive heart failure, or have not had any grade 2 or higher AEs resolved within 7 days prior to beginning study treatment.
Having active autoimmune diseases, hypothyroidism, controlled celiac disease, skin diseases not requiring systemic treatment, or any other disease that is not expected to recur in the absence of external triggering factors are also grounds for exclusion from the trial.
Immix Biopharma announces early positive IMX-110 interim clinical trial data demonstrating 100% tumor shrinkage in advanced metastatic colorectal cancer at the lowest dose of IMX-110 + BeiGene / Novartis anti-PD-1 antibody tislelizumab. News release. Immix Biopharma, Inc. May 3, 2023. Accessed May 4, 2023. yhoo.it/3nwU3zs