KGX101 alone and with envafolimab for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I, open-label, multi-center dose-escalation and expansion trial enrolling adults with advanced or metastatic solid tumors who have exhausted standard therapies. Participants receive KGX101 alone or in combination with envafolimab every three weeks, with close safety monitoring and regular clinic visits. The primary goals are to characterize safety, tolerability, and to identify a recommended Phase 2 dose for both monotherapy and combination regimens. Early visit intensity is high (about 6–8 visits in the first month) followed by assessments roughly every three weeks thereafter.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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;
2. Eastern cooperative oncology grous performance status of 0-1;
3. Has at least 1 measurable lesion per RECIST 1.1;
4. 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;
5. Life expectancy of at least 3 months;
6. Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses.

Exclusion Criteria:

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

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fudan university Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jun Guo — Beijing Cancer Hopspital
• Study coordinator: Jun Guo
• Email: guoj307@126.com
• Phone: 13911233048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.