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

NCT07702955 | Not Yet Recruiting Phase 1

• 1 other identifier: KGX105ST102
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. The study consists of two parts: Phase 1a dose escalation and Phase 1b dose expansion.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Numbers of participants with adverse events(Phase Ia)

  AE will be collected to assess participants' safety after KGX105 monotherapy

  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

  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

  From screening until 90 days post the last dose administration

• The maximum tolerated dose of KGX105 monotherapy(Phase Ia)

  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.

  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

  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)

  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

  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

  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

  From Day 1 after the first dose of KGX105 till survival follow-up every 90 days post the last treatment.

Study Arms (7)

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

Interventions

KGX105 injection DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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;

Sponsors & Collaborators

• Kangabio AUSTRALIA LTD PTY: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Li Zhang

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang

CONTACT

86-020-8743990; zhangli@syscc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

CN (1)