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NCT06074497
This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy with Envafolimab in Patients with Advanced or Metastatic Solid Tumors.
Phase 1 trial testing KGX101- Cohort -1 in Advanced or Metastatic Solid Tumors in 54 participants. Participants enrolled and being followed up; not accepting new ones.
30 May 2026
Quick facts
| Lead sponsor | Kangabio AUSTRALIA LTD PTY |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 13 December 2023 |
| Primary completion | 30 May 2026 |
| Estimated completion | 30 May 2026 |
| Sites | 3 locations across Australia |
Drugs / interventions tested
- KGX101- Cohort -1 — full drug profile →
- KGX101- Cohort 1
- KGX101- Cohort 2
- KGX101- Cohort 3
- KGX101- Cohort 4
- KGX101- Cohort 5
- KGX101 and 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
18 and older, any sex, with Advanced or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic solid tumors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06074497
- 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
- NCT07260305 — A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolima · Phase 1 · 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
Other Kangabio AUSTRALIA LTD PTY trials
Trials by the same sponsor.
- NCT07260305 — A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolima · Phase 1 · 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 NCT06074497 (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: 7 February 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/NCT06074497.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing