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NCT06198426
A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Phase 1, PHASE2 trial testing IBI3004 in Solid Tumor in 5 participants. Terminated before completion.
16 December 2025
Quick facts
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 19 August 2024 |
| Primary completion | 16 December 2025 |
| Estimated completion | 16 December 2025 |
| Sites | 5 locations across China, Australia |
Drugs / interventions tested
- IBI3004 — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, multicenter, dose escalation and expansion phase I /II study of IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size is 46. One or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06198426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Innovent Biologics (Suzhou) Co. Ltd. trials
Trials by the same sponsor.
- NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
- NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
- NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
- NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
- NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · Phase 2 · not yet 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 NCT06198426 (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 Innovent Biologics (Suzhou) Co. Ltd.
- Last refreshed: 30 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/NCT06198426.
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