A Phase 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants with Solid Tumors

ENROLLING
Protocol # :
22-547
Conditions
Triple Negative Breast Cancer
Breast Cancer
Endometrial Cancer
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Adenoid Cystic Carcinoma
Phase
I
Disease Sites
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Principal Investigator
Giordano, Antonio
Site Research Nurses
Bowers, Jordan
Campbell, Margaret
Cung, Connie
Ficociello, Samantha
Gotthardt, Susan, Jean
Jeon, Maryangel, H.
Kasparian, Elizabeth
Kuhlman, Rachel
Orechia, Meghan
Patel, Nikita
Sidoti, Emma, Grace

Trial Description

A Study of XMT-1660 in Solid Tumors

Eligibility Requirements

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:

1. All participants with TNBC

2. 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.

1. Participants are eligible if CNS metastases are adequately treated, and
participants are neurologically stable for at least 2 weeks prior to enrollment.

2. 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

3. 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

22-547