Open
Actively Recruiting
A Study of XMT-1660 in Participants With Solid Tumors
About
Brief Summary
A Study of XMT-1660 in Solid Tumors
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Recurrent or advanced solid tumor and has disease progression after treatment with available anti-cancer therapies known to confer benefit or is intolerant to treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- At least one measurable lesion(s) as defined by RECIST version 1.1.
- Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1
- Brain magnetic resonance imaging (MRI) during the Pre- Screening/Screening period unless obtained within 30 days prior to enrollment (based on standard clinical care), if they meet either of the following criteria:
- All participants with TNBC
- Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.
Exclusion Criteria:
- Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.
- Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy within 14 days of starting study treatment.
- Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.
- Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
- Participants are eligible if CNS metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment.
- In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg daily prednisone (or equivalent). Anticonvulsants are allowed except for those drugs associated with liver toxicity
- Participants may be eligible if CNS lesions are asymptomatic, equivocal for metastases or do not require specific therapy in the opinion of the investigator
- Prior B7-H4 targeted treatment.
- History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.
- Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.
- Clinically significant cardiovascular disease
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Study Stats
Protocol No.
23-001369
Category
Breast Cancer
Principal Investigator
Contact
Location
- UCLA Burbank
- UCLA Parkside