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NCT05116007
Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC
Completed
Phase 1
Last updated 31 May 2024
What this trial tests
Phase 1 trial testing AK112 in SCLC, Extensive Stage in 35 participants. Completed in 4 December 2023.
Timeline
29 March 2021
Primary endpoint
4 December 2023
4 December 2023
4 December 2023
Quick facts
| Lead sponsor | Akeso |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 29 March 2021 |
| Primary completion | 4 December 2023 |
| Estimated completion | 4 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- AK112 — full drug profile →
- Etoposide (etoposide) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- SCLC, Extensive Stage — all drugs for SCLC, Extensive Stage →
Sponsor
Akeso — full company profile →
Who can join
Adults 18 to 75, any sex, with SCLC, Extensive Stage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase Ib open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with chemotherapy in patients with ES-SCLC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring the crosstalk between endothelial cells, immune cells, and immune checkpoints in the tumor microenvironment: new insights and therapeutic implications.
Fang J, Lu Y, Zheng J, Jiang X, et al · · 2023 · cited 131× · PMID 37666809 · DOI 10.1038/s41419-023-06119-x -
Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276 -
Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
Cheng W, Kang K, Zhao A, Wu Y. · · 2024 · cited 110× · PMID 39068460 · DOI 10.1186/s13045-024-01581-2 -
Endothelial cells in tumor microenvironment: insights and perspectives.
Leone P, Malerba E, Susca N, Favoino E, et al · · 2024 · cited 90× · PMID 38426109 · DOI 10.3389/fimmu.2024.1367875 -
Bispecific antibodies targeting immunomodulatory checkpoints for cancer therapy.
Zhang T, Lin Y, Gao Q. · · 2023 · cited 47× · PMID 36971124 · DOI 10.20892/j.issn.2095-3941.2023.0002 -
A 2022 Update on Extensive Stage Small-Cell Lung Cancer (SCLC).
Oronsky B, Abrouk N, Caroen S, Lybeck M, et al · · 2022 · cited 46× · PMID 35912017 · DOI 10.7150/jca.75622 -
Immune Checkpoint Inhibitor Combined with Antiangiogenic Agent Synergistically Improving the Treatment Efficacy for Solid Tumors.
Zhou Y, Liu Z, Yu A, Zhao G, et al · · 2024 · cited 17× · PMID 39763508 · DOI 10.2147/itt.s494670 -
Therapeutic targeting of VEGF and/or TGF-β to enhance anti-PD-(L)1 therapy: The evidence from clinical trials.
Li L, Wen Q, Ding R. · · 2022 · cited 17× · PMID 35957885 · DOI 10.3389/fonc.2022.905520
Verify or expand the search:
- PubMed search for NCT05116007
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AK112
Trials testing the same drug.
- NCT07357220 — A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases · Phase 1, PHASE2 · not yet recruiting
- NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N · Phase 1, PHASE2 · recruiting
- NCT07021950 — AK112 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI as Second-line Treatment of MSS/pMMR Metastatic Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07052253 — A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. · Phase 2 · recruiting
- NCT07010263 — A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progress · Phase 3 · recruiting
Other recruiting trials for SCLC, Extensive Stage
Currently open trials in the same condition.
- NCT07480213 — Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC) · Phase 1, PHASE2 · recruiting
- NCT07413042 — A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizum · Phase 1 · recruiting
- NCT07110103 — Golidocitinib With PD-1 Inhibitors as Maintenance Treatment for Previously Untreated ES-SCLC · Phase 2 · recruiting
- NCT06812260 — A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Pa · Phase 2 · recruiting
- NCT07508852 — 68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Other Akeso trials
Trials by the same sponsor.
- NCT07449780 — A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XEL · Phase 3 · not yet recruiting
- NCT07412613 — Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer · Phase 3 · not yet recruiting
- NCT07357220 — A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases · Phase 1, PHASE2 · not yet recruiting
- NCT07436234 — A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis · Phase 2 · not yet recruiting
- NCT07436221 — A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma · 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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05116007 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Akeso
- Last refreshed: 31 May 2024
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/NCT05116007.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing