BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors

Phase 1

Waitlist Available

Led By Timothy A Yap

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, elimusertib and copanlisib, for treating advanced cancers that have spread. It targets patients with specific molecular features whose cancers have not responded to other treatments. The drugs aim to stop cancer growth by blocking essential enzymes. Copanlisib has shown promising results in various cancer types.

Eligible Conditions

Solid Tumors
Bone Metastasis
Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs)

Incidence of dose limiting toxicities (DLTs)

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response

Objective response rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (elimusertib, copanlisib)Experimental Treatment2 Interventions

Patients receive elimusertib PO BID on days 1-3 and 15-17, and copanlisib IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive elimusertib PO BID and copanlisib IV at the discretion of the treating physician.

Group II: Arm I (elimusertib, copanlisib)Experimental Treatment2 Interventions

Patients receive Patients receive elimusertib PO BID on days 1-3 and 15-17, and copanlisib IV over 1 hour on days 4 and 18. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may continue to receive elimusertib PO BID and copanlisib IV at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copanlisib

2016

Completed Phase 2

~130

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