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NCT07124793
A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors
Phase 2 trial testing IBI363+IBI305 in EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer in 60 participants. Not yet recruiting.
30 September 2026
Quick facts
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 31 August 2025 |
| Primary completion | 30 September 2026 |
| Estimated completion | 30 September 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- IBI363+IBI305 — full drug profile →
Conditions studied
- EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer — all drugs for EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer →
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
CIBI363A203, a Phase 2 study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with IBI305 (a bevacizumab biosimilar) in participants with advanced malignancies conducted in China. Primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include DoR, DCR, TTR, PFS, per RECIST v1.1, and OS; the incidence and severity of AEs, irAEs, SAEs, AESIs and their relationship to the investigational drug, and changes in vital signs, physical examination, and laboratory values before and after study treatment; PK, and immunogenicity of IBI363. The cohorts include: IBI363 and IBI305 combination therapy in participants with advanced EGFRmut NSCLC progressed after EGFR TKI and Platinum-based chemotherapy, and advanced platinum-resistant ovarian cancer (PROC). The anticipated enrollment for this study is approximately 60 participants with each cohort 30 participants, and actual enrollment may change with future amendments as cohorts are opened and closed based on evolving data.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07124793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 NCT07124793 (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: 15 August 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/NCT07124793.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing