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NCT05460767
Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma
Phase 1 trial testing IBI363 in Solid Tumors or Lymphoma in 260 participants. Status unknown.
31 March 2024
Quick facts
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 260 |
| Start date | 31 August 2022 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- IBI363 — full drug profile →
Conditions studied
- Solid Tumors or Lymphoma — all drugs for Solid Tumors or Lymphoma →
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. — full company profile →
Who can join
18 and older, any sex, with Solid Tumors or Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is an open-label, multicenter, phase Ia/Ib study. The study will evaluate the safety, tolerability and preliminary efficacy of IBI363 in subjects with advanced, relapsed or metastatic solid tumors or lymphoma, determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), and thus determine the recommended phase 2 dose (RP2D).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539 -
IL-2 based cancer immunotherapies: an evolving paradigm.
Rokade S, Damani AM, Oft M, Emmerich J. · · 2024 · cited 39× · PMID 39114660 · DOI 10.3389/fimmu.2024.1433989 -
Advances and clinical applications of immune checkpoint inhibitors in hematological malignancies.
Sun W, Hu S, Wang X. · · 2024 · cited 19× · PMID 39073258 · DOI 10.1002/cac2.12587 -
Advancements and challenges in immunocytokines: A new arsenal against cancer.
Shi W, Liu N, Lu H. · · 2024 · cited 15× · PMID 39664443 · DOI 10.1016/j.apsb.2024.07.024 -
Current landscape and future prospects of interleukin-2 receptor (IL-2R) agonists in cancer immunotherapy.
Tanigawa K, Redmond WL. · · 2025 · cited 14× · PMID 39812092 · DOI 10.1080/2162402x.2025.2452654 -
Bispecific Antibodies in Solid Tumors: Advances and Challenges.
Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838 -
Targeting γc family cytokines with biologics: current status and future prospects.
Bick F, Blanchetot C, Lambrecht BN, Schuijs MJ. · · 2025 · cited 5× · PMID 39967341 · DOI 10.1080/19420862.2025.2468312 -
Advanced cytokine-based immunotherapies: targeted cis-delivery strategies for enhanced anti-tumor efficacy and reduced toxicity.
Pousse L, Manchala A, Klein C, Codarri Deak L. · · 2025 · cited 4× · PMID 41238404 · DOI 10.1080/19420862.2025.2590250
Verify or expand the search:
- PubMed search for NCT05460767
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IBI363
Trials testing the same drug.
- NCT07402070 — IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
- NCT07307053 — Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2) · Phase 1, PHASE2 · not yet recruiting
- NCT07217301 — IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed · Phase 3 · recruiting
- NCT07122687 — IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage · Phase 2 · recruiting
- NCT06797297 — A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectabl · Phase 2 · recruiting
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 NCT05460767 (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 Innovent Biologics (Suzhou) Co. Ltd.
- Last refreshed: 29 December 2023
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/NCT05460767.
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