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NCT04203719
A Study of Anlotinib and AK105 Injection in Subjects With Advanced Head, Neck and Chest Cancer
Phase 2 trial testing AK105 in Advanced Head, Neck and Chest Cancer in 140 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 9 May 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 30 May 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Advanced Head, Neck and Chest Cancer — all drugs for Advanced Head, Neck and Chest Cancer →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Advanced Head, Neck and Chest Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
AK105 is a humanized monoclonal antibody that specially binds to PD-1. Anlotinib is a small molecule tyrosine kinase inhibitor. Based on the mechanism study, tumor vascular abnormalities promote tissue hypoxia and increase lactic acid, thereby activating immunosuppression and inhibiting T cell function. Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic Targeting of FGFR Signaling in Head and Neck Cancer.
Wang Z, Anderson KS. · · 2022 · cited 22× · PMID 36165723 · DOI 10.1097/ppo.0000000000000615 -
Emerging therapeutic strategies for enhancing sensitivity and countering resistance to programmed cell death protein 1 or programmed death-ligand 1 inhibitors in non-small cell lung cancer.
Villaruz LC, Blumenschein GR, Otterson GA, Leal TA. · · 2023 · cited 10× · PMID 36848319 · DOI 10.1002/cncr.34683 -
A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma: In-Depth Analysis of Nintedanib Arm from the KCSG HN 15-16 TRIUMPH Trial.
Kim KH, Lim SM, Ahn HK, Lee YG, et al · · 2024 · cited 7× · PMID 37475136 · DOI 10.4143/crt.2023.433 -
Penpulimab combined with anlotinib in patients with R/M HNSCC after failure of platinum-based chemotherapy: a single-arm, multicenter, phase Ⅱ study.
Shi Y, Gao L, Tian Y, Bai C, et al · · 2023 · cited 5× · PMID 38100934 · DOI 10.1016/j.esmoop.2023.102194 -
Efficacy and safety of anlotinib plus penpulimab as second-line treatment for small cell lung cancer: A multicenter, open-label, single-arm phase II trial.
Zhang C, Chen J, Wu H, Wang J, et al · · 2024 · cited 4× · PMID 39371104 · DOI 10.1016/j.cpt.2024.02.001 -
Anlotinib plus oral fluoropyrimidine S-1 in refractory or relapsed small-cell lung cancer (SALTER TRIAL): a multicenter, single-arm, phase II trial.
Wang W, Wu G, Luo W, Lin L, et al · · 2024 · cited 4× · PMID 39333988 · DOI 10.1186/s12885-024-12954-8 -
[FGFR-targeted therapy in head and neck carcinomas].
Dietrich D. · · 2021 · cited 3× · PMID 32519203 · DOI 10.1007/s00106-020-00893-2
Verify or expand the search:
- PubMed search for NCT04203719
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AK105
Trials testing the same drug.
- NCT04736810 — A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal Carcinoma · Phase 2 · completed
- NCT04207463 — A Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine · Phase 2 · unknown
- NCT04172506 — A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors · Phase 1, PHASE2 · completed
- NCT03866967 — A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma · Phase 2 · completed
- NCT03866993 — A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer · Phase 3 · completed
Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed
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 NCT04203719 (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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 23 June 2020
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/NCT04203719.
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