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About the Phase 1a/1b Trial of IMGS-001
Trial Name: A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors
ClinicalTrials.gov Identifier: NCT06014502
Recruitment Contact: Charles Schweizer, PhD, 346-772-0336, firstname.lastname@example.org
Completion Date: December 2027
The first patient has been dosed in the first-in-human phase 1a/1b trial (NCT06014502) evaluating IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care (SoC) treatment.1
"PD-L1 and PD-L2 are widely expressed not only on various tumors but also on immunosuppressive cells in the tumor microenvironment," said acting chief medical officer of ImmunoGenesis, Jeremy Barton, MD, in a press release. "IMGS-001 is designed to remove these immunosuppressive cells and potentially improve PD-1 pathway blockade. This Phase 1a/1b clinical trial is an important first step towards validating this approach as potentially effective in treating cold, immune-excluded cancers."
IMGS-001 is a dual-specific PD-L1/PD-L2 antibody made with cytotoxic function. The product is designed to treat cold, immune-excluded tumors that are resistant to existing immunotherapy. IMGS-001 is the first molecule to be tested in a clinical setting that aims to target PD-L2 in addition to PD-L1 to potentially improve blockade of the PD-1 pathway.
In preclinical trials, IMGS-001 generated higher response rates in head-to-head studies vs currently available immunotherapies, showing that IMGS-001 may provide a new foundational therapy for patients with cancer.
The phase 1a/1b first-in-human, open-label, multicenter, dose-escalation, and dose-expansion study is assessing the safety, pharmacokinetics (PK), and preliminary antitumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors that are refractory to SoC treatment.2
In the first part of the trial, the dose-escalation portion, investigators aim to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001 in this patient population and will enroll approximately 25 patients. This portion of the study plans to include patients with ovarian, colorectal, and triple-negative breast cancers.
Based on the MTD, as well as tolerability, PK, pharmacodynamics, target engagement, and more, 2 doses of IMGS-001 will be selected for further evaluation.
Part 2 is the dose-expansion part of the study where 5 prespecified tumor cohorts will be evaluated to assess preliminary antitumor activity of IMGS-001 in patients that are refractory or intolerant to other appropriate prior standard therapies. For this part of the study, patients are required to have confirmed PD-L1 expression.
Patients must be aged ≥ 18, have an ECOG performance status of 0-1, a life expectancy > 3 months, adequate bone marrow and organ function, and at least 1 measurable lesion as defined by iRECIST.
The open-label, multicenter, phase 1a/1b trial is ongoing at The University of Texas MD Anderson Cancer Center in Houston, Texas, and plans to enroll approximately 105 patients. The study has an estimated completion date of December 2027.
"Many tumors are not responsive to the current immunotherapies, representing a significant unmet need," said James Barlow, president and chief executive officer of ImmunoGenesis, in a press release.1 "Our vision is to unlock the potential of immunotherapy for a broader group of patients by targeting key mechanisms of immune resistance. We believe that this study will deliver initial proof of concept for our groundbreaking multitasking approach of using a single molecule to address immunosuppression and PD-1 pathway blockade."
ImmunoGenesis doses first patient in phase 1a/1b clinical trial of IMGS-001 in relapsed or refractory advanced solid tumors. News release. ImmunoGenesis. September 28, 2023. Accessed October 18, 2023. https://tinyurl.com/337yjh3a
Study to evaluate IMGS-001 treatment in patients with relapsed or refractory advanced solid tumors. ClinicalTrials.gov. Updated October 5, 2023. Accessed October 18, 2023. https://tinyurl.com/rxb7t9zj