Floatz Rating
CC44/100
Confidence
Indicative
Sponsor
M.D. Anderson Cancer Center
Modality
Small molecule
Development Phase
Phase 1/2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
35High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05010096CT.gov BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors | — | Withdrawn | — | — | — |
NCT04317105CT.gov Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN | — | Active Not Recruiting | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT03842228CT.gov Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations | — | Active Not Recruiting | — | — | — |
NCT03502733CT.gov Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma | — | Active Not Recruiting | — | — | — |
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 · Metastatic Malignant Neoplasm
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Copanlisib (this asset) | M.D. Anderson Cancer Center | P1/2 | CC · 44 |
| Fluorouracilum | I-Mab Biopharma US Limited | P3 | BB |
| Irinotecan | Incyte Corporation | P3 | BB |
| Nivestim | Mayo Clinic | P3 | BB |
| Cyclophosphamide | InSilico Medicine Hong Kong Limited | P2/3 | BB |
| Pembrolizumab | InSilico Medicine Hong Kong Limited | P2/3 | BB |
| Letrozole | UNICANCER | P3 | BB |
| Enfortumab Vedotin (Fully Human Monoclonal Antibody Conjugated To A Cytotoxic Agent Monomethyl Auristatin E (Mmae) Targeting Nectin-4) | National Cancer Institute (NCI) | P2/3 | BB |
| Anastrozole | UNICANCER | P3 | BB |
+42 more in the Metastatic Malignant Neoplasm cohort
Other indications for Copanlisib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Non-Hodgkin Lymphoma | — | P3 | B · 61 |
| Breast Cancer | — | P2 | B · 57 |
| Breast Carcinoma | — | P2 | B · 57 |
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. Copanlisib in Metastatic Malignant Neoplasm. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/copanlisib-metastatic-malignant-neoplasm
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