A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients

NCT07260305 | Recruiting Phase 1

• 1 other identifier: KGX101ST102
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Numbers of participants with adverse events

  AE will be collected to assess participants' safety after KGX101 monotherapy or combo with Envafolimab

  From baseline to 30 days after the last dose administration.

• Number of participants with dose limiting toxicities/DLT within DLT observation period

  DLT will be observed from start of the first priming dose of KGX101 until 21 days post the first target dose of KGX101

  From Day1 after the first priming dose of KGX101 until 21 days post the first target dose ofKGX101

• Number of participants with changes of clinical lab abnormalities

  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 KGX101 monotherapy and combination therapy with Envafolimab

  From Day 1 post the first dosing until 21 days post the the first target dosing

Secondary Outcomes (11)

• PK parameters: Maximum Concentration (Cmax) of total IL-12

  Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.

• PK Parameters: Time of maximum observed concentration (Tmax)of total IL-12

  Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.

• PK Parameters: Area under the curve (AUC)

  Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.

• PK Parameters: Half- life (T1 /2)

  Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.

• PK Parameters- Trough concentration (Ctrough)

  Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.

Study Arms (9)

KGX101 monotherapy-Dose level 1

EXPERIMENTAL

Drug: KGX101 injection

KGX101 monotherapy-Dose level 2

EXPERIMENTAL

Drug: KGX101 injection

KGX101 monotherapy-Dose level 3

EXPERIMENTAL

Drug: KGX101 injection

KGX101 monotherapy-Dose level 4

EXPERIMENTAL

Drug: KGX101 injection

KGX101 monotherapy dose expansion

EXPERIMENTAL

Drug: KGX101 injection

KGX101 combo with Envafolimab-Dose level 1

EXPERIMENTAL

Drug: KGX101 injection; Drug: Envafolimab

KGX101 combo with Envafolimab-Dose level 2

EXPERIMENTAL

Drug: KGX101 injection; Drug: Envafolimab

KGX101 combo with Envafolimab-Dose level 3

EXPERIMENTAL

Drug: KGX101 injection; Drug: Envafolimab

KGX101 combo with Envafolimab dose expansion

EXPERIMENTAL

Drug: KGX101 injection; Drug: Envafolimab

Interventions

KGX101 injection DRUG

KGX101 is a heterodimeric IL-12 prodrug with the C-terminus of IL-12 fused with ADCC-impaired IgG1 Fc and the N-terminus of IL-12 masked using the IL-12 binding domains of IL-12Rβ1 and IL-12Rβ2. KGX101 injection is a sterile, white or white-like lyophilized powder, supplied at 4.0 mg/vial for single use.

KGX101 combo with Envafolimab dose expansion; KGX101 combo with Envafolimab-Dose level 1; KGX101 combo with Envafolimab-Dose level 2; KGX101 combo with Envafolimab-Dose level 3; KGX101 monotherapy dose expansion; KGX101 monotherapy-Dose level 1; KGX101 monotherapy-Dose level 2; KGX101 monotherapy-Dose level 3; KGX101 monotherapy-Dose level 4

Envafolimab DRUG

Envafolimab is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment formulated for subcutaneous injection.

KGX101 combo with Envafolimab dose expansion; KGX101 combo with Envafolimab-Dose level 1; KGX101 combo with Envafolimab-Dose level 2; KGX101 combo with Envafolimab-Dose level 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit;
• Eastern cooperative oncology grous performance status of 0-1;
• Has at least 1 measurable lesion per RECIST 1.1;
• Has adequate organ and bone marrow function as per study which including hemoglobin \> 90 g/L, platelet count \>=100\*10e9/L, absolute meutrophil count \>=1.5\*10e9/L;
• Life expectancy of at least 3 months;
• Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses.

You may not qualify if:

• Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, breast cancer;
• Patients with primary CNS malignancies;
• Evidence of severe or uncontrolled systemic diseases, including: active infection, hypertension, chronically unhealed wound or ulcers;
• Active autoimmnue disease requiring systemic treatment in the last 2 years, or immunodefiency which is on immunosuppressive therapy, chronic systemic or enteric steroid therapy;
• History of pneumonitis, interstitial lung disease which require steroids or has current pneumonitis/ interstitial lung disease;
• Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1.

Sponsors & Collaborators

• Kangabio AUSTRALIA LTD PTY: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fudan university Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

envafolimab

Study Officials

• Jun Guo

  Beijing Cancer Hopspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Guo

CONTACT

13911233048; guoj307@126.com

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: November 17, 2025
• First Posted: December 3, 2025
• Study Start: November 27, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-11

Locations

CN (3)