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NCT06695026
A Phase 1b/2a, Open-label, Multicenter, Randomized, Dose Escalation Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination With Valganciclovir and Atezolizumab/Bevacizumab in Subjects With Hepatocellular Carcinoma
Phase 1/Phase 2 trial testing RZ-001 Dose 1 in Hepatocellular Carcinoma (HCC) in 45 participants. Currently enrolling.
1 August 2027
Quick facts
| Lead sponsor | Rznomics, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 18 December 2024 |
| Primary completion | 1 August 2027 |
| Estimated completion | 1 October 2027 |
| Sites | 9 locations across South Korea |
Drugs / interventions tested
- RZ-001 Dose 1
- RZ-001 Dose 2
- RZ-001 Dose 3
Conditions studied
- Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →
Sponsor
Rznomics, Inc. — full company profile →
Who can join
18 and older, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants with adverse events (AEs) as graded by NCI CTCAE
Time frame: Screening visit, up to 2 years -
Assessment of tumor response of target lesion where RZ-001 is administered based on the RECIST v1.1 and HCC mRECIST
Time frame: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years -
Overall response rate based on RECIST v1.1 and HCC mRECIST
Time frame: Screening visit, every 2 cycles (each cycle is 3 weeks, 6 weeks) until week 54 & every 3 cycles (each cycle is 3 weeks, 9 weeks) after week 54, up to 2 years
Sponsor's own description
This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Application of Immune Checkpoint Inhibitors in Cancer.
Chen Z, Song Z, Den S, Zhang W, et al · · 2025 · cited 2× · PMID 40787068 · DOI 10.1002/mco2.70176
Verify or expand the search:
- PubMed search for NCT06695026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
- NCT07490262 — A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular · Phase 2, PHASE3 · recruiting
- NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit · Phase 1, PHASE2 · recruiting
Other Rznomics, Inc. trials
Trials by the same sponsor.
- NCT06676891 — Expanded Access Program for GBM Subjects · available
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 NCT06695026 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rznomics, Inc.
- Last refreshed: 24 July 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/NCT06695026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing