This is a first-in-human, open-label, multicenter, Phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary antitumor activity of single-agent KGX105 in participants with locally advanced or metastatic solid tumors. The study consists of two parts: Phase 1a dose escalation and Phase 1b dose expansion.
Male or female participants with age ≥18 years, at the time of signing the informed consent.
Have received prior standard systemic anti-tumor therapy recommended by current guidelines for their tumor type and stage, and experienced disease progression or unacceptable toxicity during or after treatment;
Have no effective standard therapy available at present;
Presence of known standard contraindications to standard therapy for their tumor type; •② Prior discontinuation of standard therapy due to intolerable toxicity; •③ Explicit refusal to receive available standard therapy.
Curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ;
Localized prostate cancer or papillary thyroid carcinoma post curative resection.
Presence of leptomeningeal metastasis, spinal cord compression, symptomatic brain metastases, or brain metastases requiring steroids/antiepileptic drugs or showing radiographic progression within 4 weeks prior to enrollment.
History of allogeneic organ transplantation, allogeneic peripheral hematopoietic stem cell transplantation, or bone marrow transplantation.
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Treatment groupsSee each treatment group below.