Advanced or Metastatic Solid TumorsPhase 1NCT07702955
Phase I Study of Single-Agent KGX105 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing KGX105 injection in people with Advanced or Metastatic Solid Tumors, run by Kangabio AUSTRALIA LTD PTY at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- KGX105 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
- Adequate renal function, defined as: creatinine clearance ≥60 mL/min (measured or calculated by Cockcroft and Gault equation).
- Adequate coagulation profile, defined as (including if receiving anticoagulation therapy): prothrombin time (PT) <1.5×ULN, activated partial thromboplastin time (APTT) <1.5×ULN. If the participant is on anticoagulation therapy, must be on a stable dose of anticoagulant for ≥1 month prior to study treatment.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
- Women of childbearing potential or male partners of women of childbearing potential must agree to use highly effective contraception throughout the treatment period and for 4 months after the last dose.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this study.
Who cannot join
- 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.
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- 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.
- Receipt of any of the following treatments:
- Prior treatment with T-cell engager drugs containing CD3 antibodies. B. Within the respective washout periods or 5 half-lives (whichever is shorter) prior to the first dose: Chemotherapy, biotherapy, or immunotherapy within 4 weeks; targeted therapy, radiotherapy, endocrine therapy, or oral fluoropyrimidines within 2 weeks; anti-tumor traditional Chinese medicine within 1 week; nitrosoureas or mitomycin C within 6 weeks.
- Live or attenuated live vaccines within 4 weeks prior to the first dose (inactivated vaccines are allowed).
- Diagnosis of immunodeficiency, receipt of immunosuppressive therapy, or chronic systemic/enteral steroid therapy (>10 mg/day prednisone or equivalent).
- Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis requiring steroids or other treatment, or a history of severe pulmonary function impairment/restrictive lung disease.
- Adverse events from prior anti-tumor therapy have not resolved to CTCAE v6.0 Grade ≤1 (except for alopecia, peripheral neuropathy, ototoxicity, or stable endocrinopathies managed with hormone replacement).
- Known hypersensitivity to the active ingredient or any excipients of the investigational product.
- History of immunotherapy-related adverse events ≥ Grade 3 or leading to treatment discontinuation.
- History of active autoimmune disease likely to recur (e.g., SLE, RA, Crohn's, ulcerative colitis, vasculitis), except:
- Clinically stable autoimmune thyroid disease;
- Use of inhaled or topical corticosteroids (ocular, intra-articular, nasal) with daily dose equivalent to ≤10 mg prednisone;
- Short-term corticosteroid use (≤7 days) for prophylaxis (e.g., contrast allergy);
- Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes, physiological steroid replacement for adrenal/pituitary insufficiency).
- Presence of symptomatic pleural, peritoneal, or pericardial effusion requiring paracentesis/drainage at screening.
- •(Exclusion applies if drainage/intracavitary therapy was performed more than once [i.e., ≥2 times] for any cavity within 14 days prior to the first dose).
- History of active tuberculosis within 1 year prior to enrollment.
- History of thrombotic events (arterial or venous) within 6 months prior to screening, including cerebrovascular accidents (e.g., hemorrhage, infarction), deep vein thrombosis (DVT), and pulmonary embolism (PE).
- Exception:Catheter-related thrombosis due to PICC or port placement may be allowed if deemed stable, asymptomatic, or adequately treated with no bleeding risk by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Su Li, 86-020-87343990, lisu@syscc.org.cn
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single-Agent KGX105 in Participants With Locally Advanced or Metastatic Solid Tumors
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.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- KGX105 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KGX105 injectionDrug
KGX105 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.
| Study group | Role | What they receive |
|---|---|---|
| KGX105 monotherapy-Dose level 1 | Experimental | Not described Receives: Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 2 | Experimental | Not described Receives: Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 3 | Experimental | Not described Receives: Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 4 | Experimental | Not described Receives: Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 5 | Experimental | Not described Receives: Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 6 | Experimental | Not described Receives: Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 7 | Experimental | Not described Receives: Drug: KGX105 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with adverse events(Phase Ia)
AE will be collected to assess participants' safety after KGX105 monotherapy
Measured: From baseline to 30 days after the last dose administration.
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
Measured: From Day1 after 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
Measured: From screening until 90 days post the last dose administration
The maximum tolerated dose of KGX105 monotherapy(Phase Ia)
Measured: From Day 1 post the first dosing until 21 days post the the first target dosing
Objective Response Rate (ORR) of KGX105 monotherapy (Phase Ib)
The ratio of participants assessed with complete response (CR) or partial response (PR) as a best overall response.
Measured: until progression or death,whichever came first, assessed up to 2 years
Secondary outcomes (13)
Maximum observed concentration (Cmax) of KGX105 following single and multiple doses
Pharmacokinetic (PK) parameters
Measured: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose.
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.
Measured: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
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.
Measured: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
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.
Measured: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Progression-Free Survival (PFS) of KGX105 monotherapy
PFS defined as the time from first dose to radiographic progression or death due to any cause
Measured: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Overall Survival (OS) of KGX105 monotherapy
OS defined as the time from first dose to death due to any cause
Measured: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Immunogenicity- Anti-drug antibody (ADA)、Neutralizing Antibodies（Nab）
Samples will be collected to assess the immunogeniccity after each KGX105 treatment.
Measured: Samples will be collected to assess the immunogeniccity after each KGX105 treatment.
Numbers of participants with adverse events(Phase Ib)
AE will be collected to assess participants' safety after KGX105 monotherapy
Measured: From baseline to 30 days after the last dose administration
Number of participants with changes of clinical lab abnormalities(Phase Ib)
Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated
Measured: From screening until 90 days post the last dose administration
Phase 2 dose (RP2D) of KGX105 monotherapy (Phase Ib)
Measured: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Time to Cmax (Tmax)of KGX105 following multiple doses
Pharmacokinetic (PK) parameters
Measured: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC₀-ₜ), AUC from time zero extrapolated to infinity (AUC₀-∞)
Pharmacokinetic (PK) parameters
Measured: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose
Elimination half-life (t₁/₂) of KGX105 following multiple doses
Pharmacokinetic (PK) parameters
Measured: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangabio AUSTRALIA LTD PTY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702955
- Sponsor's protocol ID
- KGX105ST102
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single-Agent KGX105 in Participants With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07702955
- Acronym / sponsor ID
- KGX105ST102
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Kangabio AUSTRALIA LTD PTYIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| KGX105 monotherapy-Dose level 1 | Experimental | Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 2 | Experimental | Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 3 | Experimental | Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 4 | Experimental | Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 5 | Experimental | Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 6 | Experimental | Drug: KGX105 injection |
| KGX105 monotherapy-Dose level 7 | Experimental | Drug: KGX105 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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:
- Dose Expansion Phase (Phase Ib):
- 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).
Key exclusion criteria (43 listed)
- Diagnosis of another malignancy within 5 years prior to the first dose, except for:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KGX105 injectionKGX105 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. | Drug | KGX105 monotherapy-Dose level 1, KGX105 monotherapy-Dose level 2, KGX105 monotherapy-Dose level 3, KGX105 monotherapy-Dose level 4, KGX105 monotherapy-Dose level 5, KGX105 monotherapy-Dose level 6, KGX105 monotherapy-Dose level 7 |
Primary outcome
Numbers of participants with adverse events(Phase Ia)
Time frame: From baseline to 30 days after the last dose administration.
AE will be collected to assess participants' safety after KGX105 monotherapy
Incidence of Dose-Limiting Toxicities (DLTs) during the DLT observation period.(Phase Ia)
Time frame: From Day1 after the first priming dose of KGX105 until 21 days post the first target dose of KGX105
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)
Time frame: From screening until 90 days post the last dose administration
Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated
The maximum tolerated dose of KGX105 monotherapy(Phase Ia)
Time frame: From Day 1 post the first dosing until 21 days post the the first target dosing
Objective Response Rate (ORR) of KGX105 monotherapy (Phase Ib)
Time frame: until progression or death,whichever came first, assessed up to 2 years
The ratio of participants assessed with complete response (CR) or partial response (PR) as a best overall response.
13 secondary outcomes
Maximum observed concentration (Cmax) of KGX105 following single and multiple doses
Time frame: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose.
Objective Response Rate (ORR) of KGX105 monotherapy (Phase Ia)
Time frame: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Disease Control Rate (DCR) of KGX105 monotherapy
Time frame: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Duration of Response（DoR）of KGX105 monotherapy
Time frame: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Progression-Free Survival (PFS) of KGX105 monotherapy
Time frame: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Overall Survival (OS) of KGX105 monotherapy
Time frame: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Immunogenicity- Anti-drug antibody (ADA)、Neutralizing Antibodies（Nab）
Time frame: Samples will be collected to assess the immunogeniccity after each KGX105 treatment.
Numbers of participants with adverse events(Phase Ib)
Time frame: From baseline to 30 days after the last dose administration
Number of participants with changes of clinical lab abnormalities(Phase Ib)
Time frame: From screening until 90 days post the last dose administration
Phase 2 dose (RP2D) of KGX105 monotherapy (Phase Ib)
Time frame: From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.
Time to Cmax (Tmax)of KGX105 following multiple doses
Time frame: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC₀-ₜ), AUC from time zero extrapolated to infinity (AUC₀-∞)
Time frame: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose
Elimination half-life (t₁/₂) of KGX105 following multiple doses
Time frame: From pre-dose of the first dose of KGX105 treatment until Day 1 of the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KGX105 injection in people with Advanced or Metastatic Solid Tumors, run by Kangabio AUSTRALIA LTD PTY at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang (86-020-8743990, zhangli@syscc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants with adverse events(Phase Ia) (time frame: From baseline to 30 days after the last dose administration.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.