Menu
Recruiting 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

Phase I Interventional Advanced or Metastatic Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KGX101 injection, Envafolimab.
Who it may be relevant to
Registry conditions: Advanced or Metastatic Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug KGX101 injection
    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.
  • Drug Envafolimab
    Envafolimab is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment formulated for subcutaneous injection.

Primary outcome measures

  • Numbers of participants with adverse events [Time frame: From baseline to 30 days after the last dose administration.]
  • 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]
  • Number of participants with changes of clinical lab abnormalities [Time frame: From screening until 90 days post the last dose administration]
  • 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 outcome measures (11)
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • Overall survival [Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Beijing Cancer Hospital — Beijing
  • Fudan university Shanghai Cancer Center — Shanghai
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT07260305 · KGX101ST102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗