A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

Inclusion Criteria

• •1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
• •Histologically or cytologically confirmed advanced solid tumors, including the following:
• •1. Melanoma (excluding uveal melanoma)
• •2. Cervical carcinoma
• •3. Pancreatic carcinoma
• •4. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
• •5. Hepatocellular carcinoma
• •6. Urothelial carcinoma
• •7. Squamous cell carcinoma of the head and neck
• •8. Nasopharyngeal carcinoma
• •9. Renal cell carcinoma
• •10. Colorectal carcinoma
• •11. Endometrial carcinoma
• •12. NSCLC
• •13. Small cell lung cancer
• •14. Gastric or gastroesophageal junction adenocarcinoma
• •15. Sarcoma
• •2. Subjects in Part B (expansion) must have a diagnosis of any of the following:
• •Histologically or cytologically confirmed advanced solid tumors of the following types:
• •1. Non-squamous NSCLC
• •2. Melanoma
• •3. HNSCC, including NPC
• •4. CRC
• •5. UPS, including other select high grade STS, such as MFS
• •6. ccRCC
• •Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
• •1. Non-squamous NSCLC
• •2. Melanoma
• •3. HNSCC, including NPC
• •4. CRC
• •5. UPS, including other select high-grade STS such as MFS
• •6. RCC, clear cell histology (ccRCC)
• •3. Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch repair CRC with the following:
• •1. cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies
• •2. subjects will have life expectancy greater than 3 months
• •4. All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
• •5. Subjects must have measurable disease by RECIST 1.1.
• •6. All subjects must have adequate archival tumor sample (slides or archival FFPE block\[s\] containing tumor.
• •7. All subjects in Part B (dose expansion) must have a tumor lesion that can be biopsied at acceptable risk (in the judgment of the Investigator) and must agree to both a fresh biopsy during screening and a second biopsy following treatment.
• •8. Subjects have an ECOG performance status of 0-1.