MAQ-001 in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
The goal of this interventional study is to test a new monoclonal antibody, called MAQ-001, as a potential treatment for certain types of advanced cancers in different organs or compartments, such as skin, lung, kidney, liver, stomach, bowel, the female reproductive system, and hematology lymph node cancers. The main question\[s\] it aims to answer are: * the best dose of MAQ-001 that is safe to use alone or in combination with another anti-cancer medicine ipilimumab; * how MAQ-001 works in the body and how it affects the whole cancer and its cells. Participants will: * receive a defined dose of MAQ-001 or MAQ-001 in combination with ipilimumab (depending on rank of enrolment) on day 1 of a 21-day cycle, for a maximum of 2 years. * receive safety examinations and tumor assessment * donate blood and other biological materials for safety and pharmacokinetic evaluation
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥ 18 years. 2. Patients who have advanced solid tumors or lymphomas for which an anti-PD-1/PDL-1 has been approved as single agent by the EMA (including but not limited to: melanoma, NSCLC, SCLC, HNSCC, classical HD, primary mediastinal LBCL, urothelial carcinoma, MSI-H cancer, gastric cancer, esophageal cancer, cervical cancer, HCC, merkel, renal cell carcinoma, endometrial cancer, TMB-H cancer, cutaneous SCC, TNBC, unresectable basal cell cancer) with no available approved therapeutic alternatives. In addition, patients with rare tumors for which significant activity of anti-PD1 has been observed (e.g., TLS+ sarcomas, alveolar soft part sarcomas, etc.) may enroll after discussion with the Sponsor. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Histologically/cytologically confirmed diagnosis of a solid tumor malignancy 5. Measurable metastatic disease by Response Evaluation Criteria in Solid Tumors (REC