Floatz Rating
B57/100
Confidence
Indicative
Sponsor
Shenzhen Xinhe Biomedical
Modality
Small molecule
Development Phase
Phase 2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
52High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07594964CT.gov To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors | — | Recruiting | — | — | — |
NCT05733598CT.gov Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC | — | Recruiting | — | — | — |
NCT06219941CT.gov AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | — | Recruiting | — | — | — |
NCT05775159CT.gov Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer | — | Recruiting | — | — | — |
NCT05482893CT.gov Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study) | — | Recruiting | — | — | — |
NCT05489211CT.gov Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) | — | Recruiting | — | — | — |
NCT04999761CT.gov AB122 Platform Study | — | Recruiting | — | — | — |
NCT04492033CT.gov A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients | — | Terminated | — | — | — |
NCT03668418CT.gov Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos | — | Unknown | — | — | — |
NCT03044587CT.gov Nal-IRI With 5-fluorouracil (5-FU) and Leucovorin or Gemcitabine Plus Cisplatin in Advanced Biliary-tract Cancer | — | Completed | — | — | — |
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NCT03185988CT.gov Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System | — | Unknown | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Biliary Tract Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Irinotecan (this asset) | Shenzhen Xinhe Biomedical | P2 | B · 57 |
| Cis-Diamminedichloroplatinum Ii | Merck Sharp & Dohme LLC | P3 | BB |
| Epirubicin | Merck Sharp & Dohme LLC | P3 | BB |
| Pembrolizumab | Merck Sharp & Dohme LLC | P3 | BB |
| Fluorouracilum | Shenzhen Xinhe Biomedical | P2 | B |
| Capecitabine | Zhejiang Cancer Hospital | P2 | B |
| Durvalumab | Replimune, Inc. | P2 | B |
| S-1 | National Health Research Institutes, Taiwan | P2 | B |
| Datopotamab Deruxtecan | AstraZeneca | P2 | B |
+42 more in the Biliary Tract Cancer cohort
Other indications for Irinotecan
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Rectal Cancer | — | P4 | BBB · 78 |
| Exocrine Pancreatic Carcinoma | — | P2/3 | BBB · 78 |
| Colon Adenocarcinoma | — | P3 | BBB · 76 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Irinotecan in Biliary Tract Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 10, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/irinotecan-biliary-tract-cancer
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