A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects with Selected Advanced Solid Tumors (DUET-2)
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.
• Histologically or cytologically confirmed diagnosis of advanced solid tumors including:
o Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
o Hepatocellular carcinoma;
o Urothelial carcinoma;
o Squamous cell carcinoma of the head and neck;
o Renal cell carcinoma (clear cell predominant type);
o Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
o Non-small cell lung carcinoma;
o Gastric or gastroesophageal junction adenocarcinoma
o High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
o Cervical cancer;
o Squamous cell carcinoma of the anus
• All subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.
• Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
• Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the start of study drug.
• Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort dependent).
• Subjects currently receiving other anticancer therapies.
• Treatment with any other anticancer therapy within 2 weeks of the start of study drug (i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
• A life-threatening (Grade 4) immune-mediated adverse event related to prior immunotherapy.
• Failure to recover from any immune-related toxicity from prior cancer therapy to ≤ Grade 1.
• Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2.
• Active known or suspected autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs).
• Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except that inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted).
• Receipt of an organ allograft.
• Treatment with antibiotics within 14 days prior to first dose of study drug.
Multiple Tumor Types
Rom Leidner, M.D.
- Providence Cancer Institute Franz Clinic