IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

Launched by IMMATICS BIOTECHNOLOGIES GMBH · Apr 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMA401 for adults with advanced solid tumors that have either come back after treatment or have not responded to standard therapies. The main goal is to find the highest safe dose of IMA401 that can be used in future studies. Researchers will also look at how well the treatment works, how safe it is, and how the body processes the drug.

To participate, patients must be at least 18 years old and have a confirmed diagnosis of a specific type of advanced cancer that expresses certain markers (MAGEA4/8). They should have a life expectancy of more than two months and be in relatively good health overall. Participants will receive the IMA401 treatment and will be monitored closely for any side effects and how their cancer responds. It’s important for potential participants to discuss their health history with their doctor to see if this trial is a good fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures
• • Patients ≥ 18 years old
• • Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered
• • Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®)
• • Life expectancy \> 2 months
• • ECOG Performance Status of 0 to 1
• • Measurable disease according to RECIST 1.1
• • Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status
• • Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments
• • The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy
• Exclusion Criteria:
• • Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
• • History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab
• • Patients with prior allogeneic stem cell transplantation or organ transplantation
• • Patients with autoimmune diseases needing disease-directed treatment
• • Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results
• • Positive for HIV or with active hepatitis B or C infection.
• • Patients with active infection
• • Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment
• • Patients with active brain metastases and leptomeningeal metastases