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