KGX101 alone and with envafolimab for advanced or metastatic solid tumors

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

This trial will test whether KGX101 by itself or combined with envafolimab is safe and tolerable for adults in China with advanced or metastatic solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kangabio AUSTRALIA LTD PTY (Industry-sponsored)
• Drugs / interventions: envafolimab
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT07260305 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed advanced or metastatic solid tumors who have no remaining standard treatment options, an ECOG performance status of 0–1, at least one measurable lesion, and adequate organ and bone marrow function are appropriate candidates.

Not a fit: Patients with active second malignancies (except certain treated skin or in situ cancers), primary central nervous system tumors, or uncontrolled systemic illness are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, the trial could identify a safe dosing regimen and enable further testing that may lead to an additional treatment option for patients with advanced solid tumors.

How similar studies have performed: Combining novel targeted agents with PD-1/PD-L1 pathway inhibitors has shown promise in multiple tumor types and envafolimab has demonstrated clinical activity in earlier studies, but KGX101 is investigational with limited prior data.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions Advanced or Metastatic Solid Tumors