# Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

Source: https://onco.cc/trials/nct04152499/  
OnCo record `nct04152499` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Sacituzumab tirumotecan in ovarian cancer and non-small-cell lung cancer, run by Klus Pharma Inc., active and no longer recruiting.

## Summary

Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01) is a phase 1/2 interventional study registered as NCT04152499 by Klus Pharma Inc., with 1410 participants enrolled, started 2020-02-28 and due to reach its primary completion in 2026-12-31. Interventions recorded: SKB264. Conditions listed: Epithelial Ovarian Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Urothelial Carcinoma. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT04152499
- Phase: 1/2
- Setting: A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
- Sponsor: Klus Pharma Inc.
- Enrolled: 1410

## Sources

- ClinicalTrials.gov NCT04152499: https://clinicaltrials.gov/study/NCT04152499

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- drugs: [Sacituzumab tirumotecan](https://onco.cc/drugs/sacituzumab-tirumotecan/)
- companies: [Sichuan Kelun-Biotech](https://onco.cc/companies/kelun-biotech/)

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JSON: https://onco.cc/api/v1/entities/nct04152499.json