Clinical Trial 22102
- Cancer Type: Multiple
- Study Type: Treatment
- NCT#: NCT05377996
- Phase: Phase I
- Principal Investigator: Han, Heather
- 813-745-6100
- Or 1-800-679-0775
-
Overview
Study Title:
A Phase 1b, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants with Solid Tumors
Summary:
A Study of XMT-1660 in Solid Tumors
Objective:
Primary: * Determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of XMT-1660 * Assess the safety and tolerability of XMT-1660 * Assess further the safety and tolerability of XMT-1660 at MTD and/or RP2D * Assess the preliminary antitumor activity of XMT-1660 at MTD and/or RP2D Secondary: * Assess the preliminary antitumor activity of XMT-1660 * Assess the pharmacokinetics (PK) of XMT-1660, its release products, and selected metabolites * Assess the development of antidrug antibodies (ADA) and neutralizing antibodies (nAb) to XMT-1660
-
Treatments
Therapies:
Antibody-Drug Conjugate
Medications:
XMT-1660 ()
-
Inclusion Criteria
- Participant has proven recurrent or advanced solid tumor
- Participant must be at least 18 years of age or the legal age of consent of the local jurisdiction in which the study is being conducted at the time of signing of the Informed Consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participant must have at least one measurable lesion(s) as defined by RECIST version 1.1.
- Participant must be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if medically feasible, prior to C1D1. If the investigator feels a biopsy is not medically feasible, an exemption request must be submitted to the study Medical Monitor for approval
- Participant must have at least 1 measurable disease lesion(s) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Other criteria may apply
-
Exclusion Criteria
- Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload.
- Prior B7-H4 targeted treatment.
- 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 to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.
- Diagnosis of an 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.
- Participant has current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations. Further, participants are excluded with the following characteristics:
- Participant has 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). Anti-convulsants are allowed except for those drugs associated with hepatotoxicity.
- Pregnant or nursing woman
- Received a live/attenuated vaccine within 30 days before study entry (first dose) or plans to receive a live/attenuated vaccine while on study treatment through 90 days after the last dose of study treatment.
- Other criteria may apply
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.