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.
Parallel
KGX105 injection
DrugKGX105 is an investigational EGFR×CD3 TCE prodrug engineered with masked binding domains to reduce on-target, off-tumor toxicity and systemic activation. It is selectively activated in the tumor microenvironment (TME) to target EGFR-positive tumors. An integrated albumin-binding domain prolongs systemic half-life, optimizing drug exposure and efficacy.KGX105 injection is a sterile, white or slightly yellow lyophilized powder, supplied at 10.0 mg/vial for single use.
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Treatment groupsSee each treatment group below.
Numbers of participants with adverse events(Phase Ia)
AE will be collected to assess participants' safety after KGX105 monotherapy
Incidence of Dose-Limiting Toxicities (DLTs) during the DLT observation period.(Phase Ia)
DLT will be observed from start of the first priming dose of KGX105 until 21 days post the first target dose of KGX105
Number of participants with changes of clinical lab abnormalities(Phase Ia)
Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated
The maximum tolerated dose of KGX105 monotherapy(Phase Ia)
Maximum observed concentration (Cmax) of KGX105 following single and multiple doses
Pharmacokinetic (PK) parameters
Objective Response Rate (ORR) of KGX105 monotherapy (Phase Ia)
The ratio of participants assessed with complete response (CR) or partial response (PR) as a best overall response.
Disease Control Rate (DCR) of KGX105 monotherapy
The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overall response.
Duration of Response（DoR）of KGX105 monotherapy
DoR defined as the time from first documented evidence of CR or PR until disease progression or death.
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