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
| NCT ID | NCT07260305 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kangabio AUSTRALIA LTD PTY |
| Condition | Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 57 participants in total. It began in 2024-11-27 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jun Guo
PRINCIPAL INVESTIGATOR
Beijing Cancer Hopspital
Frequently Asked Questions
Who can join the NCT07260305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07260305 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07260305 currently recruiting?
Yes, NCT07260305 is actively recruiting participants. Contact the research team at guoj307@126.com for enrollment information.
Where is the NCT07260305 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07260305 clinical trial?
NCT07260305 is sponsored by Kangabio AUSTRALIA LTD PTY. The principal investigator is Jun Guo at Beijing Cancer Hopspital. The trial plans to enroll 57 participants.