A phase 1 dose escalation and cohort expansion study of ERY974, an anti-Glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumor

Completed

• Conditions: Gevorderde solide tumoren; advanced solid tumors

• Registration Number: NL-OMON47296
• Lead Sponsor: Chugai Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Key Inclusion Criteria:
* Histologically confirmed and measurable malignant solid tumor and/or metastatic disease not amenable to standard therapy or for which standard therapy is not available or not indicated
* GPC3 positive tumor by immunohistochemistry (IHC) on a biopsy sample *18 months old at the time of IHC analysis
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Adequate hematological, hepatic, renal, coagulation and nutritional status
* For female patients of child-bearing potential a negative serum pregnancy test
* Life expectancy *3 months.
Inclusion Criteria Unique to Cohort Expansion:
* Cohort A: GPC3 positive and histologically confirmed gastric or GEJ adenocarcinoma
* Cohort B: GPC3 positive and histologically confirmed head and neck squamous cell carcinoma
* Cohort C: GPC3 positive and histologically confirmed sarcoma
* Cohort D: Any other GPC3 positive solid tumor that is advanced and/or metastatic and either not amenable to standard therapy or for which standard therapy is not available or not indicated
o The cut-off value for GPC3 expression in each of the cohort expansion groups may be determined based on data generated in the dose escalation part of the study. These cut-off values will be communicated, in writing, to each site prior to initiation of cohort expansion.

Exclusion Criteria

Key Exclusion Criteria:
* Patients with more than a single brain metastasis, a single brain metastasis > 1 cm in size, or a single brain metastasis *1 cm size but not stable for 4 weeks or longer
* Current or previous interstitial lung disease evident on imaging
* Requirement of regular drainage of ascites and/or pleural effusion
* Treatment with monoclonal antibodies (except for denosumab) or other immunotherapy within 28 days prior to first receipt of study drug
* Prior treatment with other excluded therapies
* Patients with clinically significant (as determined by the investigator) acute or chronic infection or infection occurring during the 14 days prior to first receipt of study drug
* Patients with known human immunodeficiency virus
* Hepatitis B virus (HBV) surface antigen, HBV core antibody and hepatitis C (HCV) core antibody will be tested at screening. Patients with active (HBV, and/or active HCV infection or any other known active virus infection considered to be clinically relevant by the investigator.
* Major surgery within 28 days prior to first receipt of study drug
* Patients with allergic reactions attributed to components of the formulated study drug, corticosteroids or anti-histamines
* Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to have a low likelihood for recurrence).
Exclusion Criteria Unique to Dose Escalation
* Subjects with histologically confirmed lung cancer and hepatocellular carcinoma (HCC) will be excluded from the fixed dose cohorts. These subjects can be enrolled into the individual dose titration cohort.

Study & Design

• Study Type: Interventional
• Study Design: Not specified