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NCT Number: NCT07260305

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

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.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Numbers of participants with adverse events

    Time frame: From baseline to 30 days after the last dose administration.

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

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

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

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

  3. Number of participants with changes of clinical lab abnormalities

    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

  4. The maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab

    Time frame: From Day 1 post the first dosing until 21 days post the the first target dosing

Secondary outcomes

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

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

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

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

  3. PK Parameters: Area under the curve (AUC)

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

  4. PK Parameters: Half- life (T1 /2)

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

  5. PK Parameters- Trough concentration (Ctrough)

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

  6. PK Parameters- Systemic clearance (CL)

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

  7. PK Parameters- Volume of distribution (Vd)

    Time frame: 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.

    Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.

  8. Immunogenicity- Anti-drug antibody (ADA)

    Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until 90 days afrer the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until 90 days after the last dose.

    Samples will be collected to assess the immunogeniccity after each KGX101 treatment.

  9. Number of participants with changes in the Overall Response (ORR)

    Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post the last treatment.

  10. Progression free survival (PFS) per RECIST 1.1

    Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.

  11. Overall survival

    Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Guo

CONTACT

[email protected]

13911233048

Sponsors and collaborators

Lead sponsor

Kangabio AUSTRALIA LTD PTY

Industry

Registry information

Official study title

A Phase I , Open Label, Multi-center Study to Assess the Safety and Tolerability of KGX101 Mono and Combo Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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