New drug targets genetic weakness in Hard-to-Treat cancers
NCT ID NCT05490771
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called copanlisib in people whose cancers have a specific genetic mutation (PIK3CA). The drug works by blocking a protein that helps cancer cells grow. Researchers want to see if it can shrink tumors or stop them from growing. About 35 adults with advanced or hard-to-treat cancers are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Started
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Jun 2018
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * Patients must have PIK3CA mutation as determined via the MATCH Master Protocol * Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block) * Patients should stop using herbal medications at least 7 days prior to the first dose of copanlisib. Herbal medications include, but are not limited to: St. John's Wort, Kava, ephedra, gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, black cohosh and ginseng * Patients with type I or II diabetes mellitus must have glycosylated hemoglobin A1c (HbA1c) =\< 8.5% within 28 days from registration * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9 /L * Platelets \>= 100x10\^9/L * Hemoglobin (Hb) \> 9 g/dl * Total serum bilirubin \< 2.0 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN) (\< 5 x ULN in patients with liver metastases) * Serum creatinine \< 1.5 x ULN * Men and women of child-bearing potential must agree to use contraception while receiving study treatment and for 1 month after the last dose of copanlisib Exclusion Criteria: * Patients must not have known hypersensitivity to copanlisib or compounds of similar chemical or biologic composition * Patients must not have had prior therapy with copanlisib or other PI3K inhibitors, AKT inhibitors or mTOR inhibitors * Patients must not have activating KRAS mutations * Patients must not have HER2 positive (3+ by immunohistochemistry \[IHC\] or fluorescence in situ hybridization \[FISH\] ratio \>= 2) breast cancer * Patients must not have indolent non-Hodgkin lymphoma (NHL) (follicular lymphoma, small lymphocytic lymphoma \[SLL\]/chronic lymphocytic leukemia \[CLL\], lymphoplasmacytic lymphoma \[LPL\], marginal zone lymphoma) or DLBCL (diffuse large B cell lymphoma) * Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior to start of study treatment and for the duration of study treatment * Patients must not be on anti-arrhythmic therapy other than digoxin or beta-blockers * Patients with non-healing wound, ulcer, or bone fracture are not eligible * Patients with history of or current interstitial pneumonitis are not eligible * NOTE: For solid tumors, cytomegalovirus (CMV) polymerase chain reaction (PCR) can be obtained at the discretion of treating physician or local institutional guidelines
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, 19103, United States
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