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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 1 trial testing KGX101 injection in Advanced or Metastatic Solid Tumors in 57 participants. Currently enrolling.
1 January 2027
Quick facts
| Lead sponsor | Kangabio AUSTRALIA LTD PTY |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 57 |
| Start date | 27 November 2024 |
| Primary completion | 1 January 2027 |
| Estimated completion | 30 March 2027 |
| Sites | 2 locations across China |
Drugs / interventions tested
- KGX101 injection — full drug profile →
- Envafolimab — full drug profile →
Conditions studied
- Advanced or Metastatic Solid Tumors — all drugs for Advanced or Metastatic Solid Tumors →
Sponsor
Kangabio AUSTRALIA LTD PTY — full company profile →
Who can join
Adults 18 to 75, any sex, with Advanced or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07260305
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced or Metastatic Solid Tumors
Currently open trials in the same condition.
- NCT07510828 — PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07205718 — A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT06548217 — A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
- NCT05957081 — Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 · Phase 1 · recruiting
- NCT06074497 — This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Mo · Phase 1 · active not recruiting
Other Kangabio AUSTRALIA LTD PTY trials
Trials by the same sponsor.
- NCT06074497 — This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Mo · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07260305 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kangabio AUSTRALIA LTD PTY
- Last refreshed: 3 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07260305.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing