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NCT05510427
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification
Phase 1 trial testing Infigratinib in Cholangiocarcinoma. Withdrawn.
7 August 2023
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 7 August 2023 |
| Primary completion | 7 August 2023 |
| Estimated completion | 7 August 2023 |
Drugs / interventions tested
- Infigratinib (INFIGRATINIB) — full drug profile →
- Atezolizumab (atezolizumab) — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- Cholangiocarcinoma — all drugs for Cholangiocarcinoma →
- Liver Cancer — all drugs for Liver Cancer →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Cholangiocarcinoma or Liver Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To find the highest tolerable dose of infigratinib that can be given in combination with bevacizumab and atezolizumab to patients with advanced/metastatic CCA with a FGFR2 mutation.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3 -
Unleashing the potential of combining FGFR inhibitor and immune checkpoint blockade for FGF/FGFR signaling in tumor microenvironment.
Ruan R, Li L, Li X, Huang C, et al · · 2023 · cited 86× · PMID 36966334 · DOI 10.1186/s12943-023-01761-7 -
Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282 -
Recent Advances in Systemic Therapy for Advanced Intrahepatic Cholangiocarcinoma.
Yoo C, Hyung J, Chan SL. · · 2024 · cited 19× · PMID 38638168 · DOI 10.1159/000531458 -
Genetic/Epigenetic Alteration and Tumor Immune Microenvironment in Intrahepatic Cholangiocarcinoma: Transforming the Immune Microenvironment with Molecular-Targeted Agents.
Nishida N, Kudo M. · · 2024 · cited 14× · PMID 38751556 · DOI 10.1159/000534443 -
Current and novel approaches in the pharmacological treatment of hepatocellular carcinoma.
Villarruel-Melquiades F, Mendoza-Garrido ME, García-Cuellar CM, Sánchez-Pérez Y, et al · · 2023 · cited 14× · PMID 37213397 · DOI 10.3748/wjg.v29.i17.2571
Verify or expand the search:
- PubMed search for NCT05510427
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Infigratinib
Trials testing the same drug.
- NCT07393373 — Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia · Phase 2 · enrolling by invitation
- NCT06206278 — Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma · Phase 2 · terminated
- NCT05145010 — Extension Study of Infigratinib in Children With Achondroplasia (ACH) · Phase 2 · enrolling by invitation
- NCT05222165 — Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With · Phase 1, PHASE2 · withdrawn
- NCT04504331 — Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced B · Phase 1 · terminated
Other recruiting trials for Cholangiocarcinoma
Currently open trials in the same condition.
- NCT07486713 — Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies · Phase 4 · recruiting
- NCT07291947 — PULSAR Combined With Immunotherapy and Chemotherapy · Phase 1, PHASE2 · recruiting
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- NCT07263217 — Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury · NA · recruiting
- NCT07155525 — Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas · Phase 3 · recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT05510427 (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 M.D. Anderson Cancer Center
- Last refreshed: 15 August 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/NCT05510427.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing