Phase I Study of Single-Agent KGX105 in Patients With Advanced or Metastatic Solid Tumors

Starting soon · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT07702955

Run by

Kangabio AUSTRALIA LTD PTY

People needed

85

Starts

2026-08-01

Expected to finish

2028-11-01

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants with age ≥18 years, at the time of signing the informed consent.
• Dose Escalation Phase (Phase Ia):
• Participants with histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors meeting any of the following conditions:
• 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;
• Meet any of the following conditions rendering standard therapy unsuitable:
• 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.
• Priority: Non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), pancreatic cancer, and other EGFR-positive* solid tumors such as gastroesophageal junction adenocarcinoma, gastric cancer, and esophageal squamous cell carcinoma.
• Dose Expansion Phase (Phase Ib):
• Cohort 1 (EGFR-positiveNSCLC):*
• Participants with driver gene-positive NSCLC must have received approved targeted therapy for the identified driver gene unless contraindicated; treatment discontinuation must be due to disease progression or intolerable toxicity. Driver genes primarily include: EGFR exon 19 deletion, L858R mutation, or exon 20 insertion mutation.
• Participants with EGFR protein overexpression or gene amplification in driver gene-negative NSCLC must have received platinum-based chemotherapy and anti-PD-(L)1 antibody therapy (concurrent or sequential), unless contraindicated; treatment discontinuation must be due to disease progression or intolerable toxicity.
• Cohort 2 (EGFR-positiveHNSCC, NPC):*
• HNSCC participants must have received immune checkpoint inhibitors and/or platinum-based chemotherapy (with or without cetuximab).
• NPC participants must have received platinum-based chemotherapy, with or without anti-PD-(L)1 antibodies.
• Cohort 3 (Other EGFR-positivesolid tumors):*
• Pancreatic cancer, gastric cancer, gastroesophageal junction adenocarcinoma, and esophageal squamous cell carcinoma that have progressed after at least one line of standard therapy.
• Definition of EGFR-positivein this study:* Includes any of the following: EGFR protein overexpression (EGFR IHC staining intensity ≥1+), EGFR gene mutation, or EGFR gene amplification (by NGS).
• According to RECIST 1.1, there must be at least one measurable lesion (tumor lesions located in a previously irradiated area or other sites of locoregional therapy generally are not considered measurable unless they have demonstrated clear progression or have persisted for three months after radiation therapy).
• Note: Metastatic brain lesions are not considered as target lesions.
• ECOG 0-1.
• Life expectancy of ≥3 months, in the opinion of the investigator.
• Adequate organ function as determined by medical evaluation including:
• Adequate hematologic status, defined as: absolute neutrophil count (ANC) ≥1.5×109/L, hemoglobin ≥90 g/L, platelets ≥100×109/L. Platelet transfusions are not permitted within 7 days, red blood cell transfusions are not permitted within 14 days, hematopoietic growth factors are not permitted within 7 days (14 days for PEGylated G-CSF or erythropoietin) prior to obtaining these laboratory values.
• Adequate hepatic function, defined as: serum TBIL ≤1.5×ULN (in participants with known Gilbert's syndrome, TBIL ≤3×ULN with direct bilirubin ≤1.5×ULN), serum ALT or AST ≤2.5×ULN (or ≤5.0×ULN for documented liver metastasis).

You may not qualify if…

• Diagnosis of another malignancy within 5 years prior to the first dose, except for:
• 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.
• Exception:Asymptomatic brain metastases, or those stable for >4 weeks post-treatment without requiring steroids/antiepileptics, with a single lesion ≤1.5 cm and total number of lesions ≤5, are allowed.
• History of allogeneic organ transplantation, allogeneic peripheral hematopoietic stem cell transplantation, or bone marrow transplantation.
• Pregnant or breastfeeding women, or individuals planning to donate sperm/eggs during the study period (from ICF signing to 4 months after the last dose).
• Note:Breastfeeding women may be enrolled if they agree to stop breastfeeding prior to dosing and have no intention of resuming.
• Any severe or uncontrolled systemic disease, including:
• Active bleeding or known bleeding diathesis;
• Cardiac dysfunction or clinically significant cardiovascular disease, including any of the following:
• Uncontrolled cardiac disease, such as congestive heart failure requiring treatment (NYHA > Class II);
• Uncontrolled hypertension (resting BP ≥160/100 mmHg);
• Poorly controlled arrhythmias;
• ECG with QTcF >470 ms (female) or >450 ms (male) (QTcF = QT/RR¹/³), or congenital long QT syndrome;
• Echocardiogram: Left Ventricular Ejection Fraction (LVEF) ≤50%;
• Acute myocardial infarction or unstable angina within 6 months prior to study entry;
• Uncontrolled diabetes mellitus or poor compliance with hypoglycemic agents;
• Other chronic diseases that, in the investigator's opinion, may compromise participant safety or preclude completion of the study.
• Active infections:
• Known Human Immunodeficiency Virus (HIV) infection, Treponema pallidum (TP) infection;
• Active Hepatitis B [i.e., HBsAg positive and HBV DNA >1000 copies/mL (or 200 IU/mL), or HBV DNA above the lower limit of detection (if the LLOQ at the site is >200 IU/mL)];
• Hepatitis C Virus (HCV) infection (i.e., HCV antibody positive and HCV-RNA positive);
• Other active infections requiring systemic therapy within 2 weeks prior to the first dose.
• Inadequate recovery from any prior surgery, or major organ surgery (excluding core needle biopsy or vascular intervention) within 4 weeks prior to study drug administration.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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