Metastatic Melanoma and Other Solid TumorsPhase 1NCT04809805

A Study to Learn How Safe BAY2666605 is, How it Affects the Body, How it Moves Into, Through and Out of the Body, the Maximum Amount That Can be Given and Its Action Against Tumors in Adult Participants With Skin Cancer That Has Spread to Other Parts of the Body and Other Types of Advanced Cancer

A Phase 1 study testing BAY2666605 in people with Metastatic Melanoma and Other Solid Tumors, run by Bayer at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Researchers are looking for a better way to treat people who have advanced cancer. In this study researchers want to learn more about a new substance called BAY2666605. BAY2666605 triggers the formation of a complex of two proteins called SLFN12 and PDE3A. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Melanoma and Other Solid Tumors
What is being tested?: BAY2666605
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 3 sitesUnited States
Study dates: 15 Apr 2021to 27 Apr 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Pre-screening:
Signed informed consent for pre-screening
Male or female participants aged ≥ 18 years
Participants with histologically confirmed diagnosis of melanoma, glioblastoma/anaplastic astrocytoma, sarcoma or epithelial ovarian cancer/fallopian tube/primary peritoneal cancer
Availability of archival tumor tissue (5-10 for prescreening, further 20 to be provided at screening)
ECOG ≤2

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Main Screening :
Positive SLFN12/PDE3A expression in archival tumour
Minimum life expectancy at least 12 weeks
Documented radiological disease progression after treatment with all available standard of care therapies for advanced/metastatic disease and at least one measurable lesion
Adequate bone marrow, liver, and renal function
Adequate blood clotting
Left ventricular ejection fraction >50%
All AEs due to previous therapies to CTCAE Grade ≤1. Grade ≤2 neuropathy, fatigue, alopecia, or anorexia, for which further resolution is not expected, may be eligible.
Negative pregnancy test and use of highly effective contraception
Signed informed consent for main screening

Who cannot join

Pre-screening:
Any malabsorption conditions
Known HIV infection, active HBV or HCV infection
Known hypersensitivity to PDE3 inhibitors, or excipients in the formulation; concomitant treatment with any other PDE3 inhibitors
Participants with clinically relevant cardiovascular diseases and/or relevant ECG findings
Participants with history of hemorrhage, bleeding disorders or platelet function abnormalities, aneurysm or aneurysmal vasculopathy; Participants with arterial thromboembolic events (ATEs) or venous thromboembolic events (VTEs), including transient ischemic attacks or pulmonary embolism within 6 months before the start of BAY 2666605 or deep vein thrombosis within 3 months before the start of BAY 2666605; Participant with a history of gastrointestinal (GI) ulcerations or perforation, fistula formation involving any internal organs.

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Main screening
Moderate or severe hepatic impairment
History of organ allograft transplantation, including allogeneic bone marrow
Previous of co-existing cancer(s) distinct in primary site or histology from the cancer evaluated in this study (with few exceptions)
Participants with any history of primary meningeal tumors and/or Any active symptomatic or untreated central nervous system (CNS) metastases and/or a number of prior and concomitant therapies
Major surgery, significant trauma, serious non-healing wound, wound healing complications, ulcer or bone fracture within 4wks prior to 1st dose

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Development Innovations
Nashville, Tennessee, 37203
South Texas Accelerated Research Therapeutics | START San Antonio
San Antonio, Texas, 78229-3307

Other trials in United States

About this study

Official title: An Open Label, Phase 1, First-in-human, Study to Evaluate Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of Schlafen12 Complex Inducer (SLFN12 ci) BAY 2666605 in Participants With Metastatic Melanoma and Other Advanced Solid Tumors.

Researchers are looking for a better way to treat people who have advanced cancer.

In this study researchers want to learn more about a new substance called BAY2666605. BAY2666605 triggers the formation of a complex of two proteins called SLFN12 and PDE3A. This complex drive cancer cells into cell death by a mechanism called apoptosis. The complex is only formed in the cancers which contain both proteins.

This study is done in adult patients who have certain types of advanced cancers that cannot be cured by drugs that are currently available. The cancer types include skin cancer that has spread to other parts of the body and cancer that started in the bones or soft tissue, the ovaries, or the brain. Patients with these cancers are only included if the cells of the patient's cancer contain the building plan to produce SLFN12-phosphodiesterase 3A (PDE3A) complex. To confirm this, a specific test is performed with the cancer cells.

The researchers will study how BAY2666605 moves into, through and out of the body. Researchers will try to find the best dose that can be given, how safe BAY2666605 is and how it affects the body. Researchers will also study the action of BAY2666605 against the cancer. Part A will include about 36 participants and up to another 12 participants. Part B will include about 41 participants. All of the participants will take BAY2666605 by mouth as either a liquid or as tablets.

During the study, the participants will take the treatment in 4 week periods called cycles. In each cycle, the participants will in general take BAY2666605 once daily. The participants may also be asked to do overnight fasting before the intake of substance and to have standard high-fat, high-calorie breakfast on some days before taking the dose.

These 4 week cycles will be repeated throughout the trial. The participants can take BAY2666605 until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 18 visits in each cycle. Some of the visits can also be done via Phone.

During the trial, the study team will take blood and urine samples, do physical examinations and check the participants' heart health using an electrocardiogram (ECG) and an ultrasound of the heart. The study team will also take pictures of the participants' tumors using CT or MRI scans. The study team will ask how the participants are feeling, if participants have any medical problems or if participants are taking any other medicine. About 1 month and 3 months after the last dose, the participants will have another visit and a phone call respectively where participants will be checked for and asked about medical problems. The researchers will then contact the participants every 3 months until the trial ends.

Conditions: Metastatic Melanoma and Other Solid Tumors
Being tested: BAY2666605
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAY2666605Drug
One oral solution strength of BAY2666605 will be used. Two different tablet strengths of BAY2666605 will be available.

Study groups in NCT04809805
Study group	Role	What they receive
Dose escalation of BAY2666605	Experimental	Approximately 7 or 8 dose levels are planned. Receives: Drug: BAY2666605
Dose expansion of BAY2666605	Experimental	Participants will receive BAY 2666605 at the dose and regimen declared safe in the dose escalation part. Receives: Drug: BAY2666605

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and severity of TEAEs including TESAEs
TEAEs: Treatment emergent adverse events; TESAEs:Treatment emergent serious adverse events
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
The incidence of DLTs at each dose level in the Dose Escalation part of the study
DLT: Dose limiting toxicity
Measured: Up to 28 + 14 days
Maximal plasma exposure (Cmax) of BAY2666605
Measured: Cycle 1 Day 1
AUC(0-24) of BAY2666605
Measured: Cycle 1, Day 1
RP2D of BAY2666605
RP2D: Recommended phase 2 dose. RP2D will be defined in the expansion part.
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
Cmax,md of BAY2666605
Measured: Cycle 1, Day 15
AUC(0-24)md of BAY2666605
Measured: Cycle 1, Day 15

Secondary outcomes (5)

ORR
ORR: Objective response rate
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
DCR
DCR: Disease control rate
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
DOR
DOR: Duration of response
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
PFS by investigator assessment
PFS: Progression-free survival
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
OS
OS: Overall survival
Measured: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202127 Apr 2023

First posted22 Mar 2021
Study start15 Apr 2021
Primary completion9 Nov 2022
Study completion27 Apr 2023

Why it stopped: Due to the high probability of not achieving a therapeutic window and lack of evidence of sufficient clinical benefit.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Melanoma and Other Solid TumorsStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04809805
Sponsor's protocol ID: 20733
Status last verified: Nov 2023
First submitted: 5 Mar 2021
Last updated: 14 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors
Active, not recruitingPhase 1/2
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Advanced Solid Tumor, Locally Advanced Solid Tumor
RecruitingPhase 1/2
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Melanoma, Non-small Cell Lung Cancer
RecruitingPhase 2
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
Melanoma, Glioma

All Metastatic Melanoma and Other Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Phase 1, First-in-human, Study to Evaluate Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of Schlafen12 Complex Inducer (SLFN12 ci) BAY 2666605 in Participants With Metastatic Melanoma and Other Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT04809805
Acronym / sponsor ID: 20733
Conditions: Metastatic Melanoma and Other Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the high probability of not achieving a therapeutic window and lack of evidence of sufficient clinical benefit.
Enrolment: 5 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 15 Apr 2021 (actual)
Primary completion: 9 Nov 2022 (actual)
Study completion: 27 Apr 2023 (actual)
First posted: 22 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Researchers are looking for a better way to treat people who have advanced cancer.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dose escalation of BAY2666605	Experimental	Drug: BAY2666605Approximately 7 or 8 dose levels are planned.
Dose expansion of BAY2666605	Experimental	Drug: BAY2666605Participants will receive BAY 2666605 at the dose and regimen declared safe in the dose escalation part.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Signed informed consent for pre-screening
Male or female participants aged ≥ 18 years
Participants with histologically confirmed diagnosis of melanoma, glioblastoma/anaplastic astrocytoma, sarcoma or epithelial ovarian cancer/fallopian tube/primary peritoneal cancer
Availability of archival tumor tissue (5-10 for prescreening, further 20 to be provided at screening)
ECOG ≤2

Key exclusion criteria (12 listed)

Any malabsorption conditions
Known HIV infection, active HBV or HCV infection
Known hypersensitivity to PDE3 inhibitors, or excipients in the formulation; concomitant treatment with any other PDE3 inhibitors
Participants with clinically relevant cardiovascular diseases and/or relevant ECG findings
Participants with history of hemorrhage, bleeding disorders or platelet function abnormalities, aneurysm or aneurysmal vasculopathy; Participants with arterial thromboembolic events (ATEs) or venous thromboembolic events (VTEs), including transient ischemic attacks or pulmonary embolism within 6 months before the start of BAY 2666605 or deep vein thrombosis within 3 months before the start of BAY 2666605; Participant with a history of gastrointestinal (GI) ulcerations or perforation, fistula formation involving any internal organs.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BAY2666605One oral solution strength of BAY2666605 will be used. Two different tablet strengths of BAY2666605 will be available.	Drug	Dose escalation of BAY2666605, Dose expansion of BAY2666605

Primary outcome

Incidence and severity of TEAEs including TESAEs
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
TEAEs: Treatment emergent adverse events; TESAEs:Treatment emergent serious adverse events
The incidence of DLTs at each dose level in the Dose Escalation part of the study
Time frame: Up to 28 + 14 days
DLT: Dose limiting toxicity
Maximal plasma exposure (Cmax) of BAY2666605
Time frame: Cycle 1 Day 1
AUC(0-24) of BAY2666605
Time frame: Cycle 1, Day 1
RP2D of BAY2666605
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
RP2D: Recommended phase 2 dose. RP2D will be defined in the expansion part.
Cmax,md of BAY2666605
Time frame: Cycle 1, Day 15
AUC(0-24)md of BAY2666605
Time frame: Cycle 1, Day 15

5 secondary outcomes

ORR
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
DCR
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
DOR
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
PFS by investigator assessment
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.
OS
Time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.

Results and safety

The study was stopped early (reason given: Due to the high probability of not achieving a therapeutic window and lack of evidence of sufficient clinical benefit.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Related trials for Metastatic Melanoma and Other Solid Tumors

RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors
Active, not recruitingPhase 1/2
A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Advanced Solid Tumor, Locally Advanced Solid Tumor
RecruitingPhase 1/2
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
Melanoma, Non-small Cell Lung Cancer
RecruitingPhase 2
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
Melanoma, Glioma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY2666605 in people with Metastatic Melanoma and Other Solid Tumors, run by Bayer at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of TEAEs including TESAEs (time frame: Up to 6 months after the last participant's first study intervention or until the end of the study, whichever comes first.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04809805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.