Clinical Trial 22102

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT05377996

Phase: Phase I
Principal Investigator: Han, Heather

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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 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

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

Exclusion Criteria

Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin or maytansinoid payload. Prior treatment with another ADC containing non-auristatin or non-maytansinoid payload 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 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.

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.

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