A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
18 Years and older, Male and Female
XmAb23104-01 (primary)
NCI-2019-00828
DUET-3
Summary
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and
regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity,
and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination
therapy with ipilimumab in subjects with selected advanced solid tumors.
Eligibility
- 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:
- Melanoma (excluding uveal melanoma)
- Cervical carcinoma
- Pancreatic carcinoma
- Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
- Hepatocellular carcinoma
- Urothelial carcinoma
- Squamous cell carcinoma of the head and neck
- Nasopharyngeal carcinoma
- Renal cell carcinoma
- Colorectal carcinoma
- Endometrial carcinoma
- NSCLC
- Small cell lung cancer
- Gastric or gastroesophageal junction adenocarcinoma
- Sarcoma
- 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:
- Non-squamous NSCLC
- Melanoma
- HNSCC, including NPC
- CRC
- UPS, including other select high grade STS, such as MFS
- ccRCC Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
- Non-squamous NSCLC
- Melanoma
- HNSCC, including NPC
- CRC
- UPS, including other select high-grade STS such as MFS
- RCC, clear cell histology (ccRCC)
- Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch repair CRC with the following:
- cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies
- subjects will have life expectancy greater than 3 months
- All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
- Subjects must have measurable disease by RECIST 1.1.
- All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
- 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.
- Subjects have an ECOG performance status of 0-1.
Treatment Sites in Georgia
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