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A first-in-human study to learn how safe the study treatment BAY2965501 is, to find the best dose(single drug & combination), how it affects the body, what maximum amount can be given, how it moves into, through and out of the body, and
how it acts on different tumors in participants with advanced solid tumors

DGKzeta inhibitor BAY 2965501 FiH trial in advanced solid cancers

Tanigawa Takahiko

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

byl_ct_contact@bayer.com

Dedicated contact

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

+81-6-6133-6363

byl_ct_contact@bayer.com

Complete

Mar. 27, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Have measurable disease per Response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) as assessed by the local site investigator.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Participants with histologically confirmed diagnosis of a solid tumor(specifications for the different parts of the study below)will be enrolled onto this study.
- Dose escalation: All solid cancers, except primary central nervous system cancers.
The following tumor types will be recruited to the monotherapy expansion cohorts:
oNon-small cell lung cancer(NSCLC)
oGastric/Gastroesophageal Junction(GEJ) adenocarcinoma
The following tumor types will be recruited to the BAY3965501 and pembrolozmab combination expansion cohorts:
oNSCLC: participants with tumors that are TPS score >=50% PDL-1 high (based on local historical testing) and are eligible for standard of care anti-PD(L)-1 monotherapy in the first line incurable treatment setting.
oNSCLC
oGastric/GEJ adenocarcinoma.

- Previous therapy with a diacylglycerol kinase (DGK) inhibitor.is prohibited for monotherapy cohorts(participants previously treated with BAY2965501 or BAY2862789 must have progressed on that DGK inhibitor (and not discontinued for toxicity) to be eligible for combination).
- Has received a prior therapeutic regimen containing an anti - PD - 1, anti - PD - L1, or anti PD - L2 agent or an agent directed to another stimulatory or co-inhibitory T - cell receptor (e.g., CTLA - 4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher infusionrelated adverse event (irAE) .
- Participants with new brain metastases on screening brain MRI/CT. Previously treated brain metastases that are progressive at screening compared to a brain MRI/CT at least 6 weeks earlier are also excluded. Participants with known previously treated brain metastases, which are radiologically stable compared to a CT/MRI scan at least 6 weeks earlier, clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of study treatment may be eligible.
- Primary central nervous system malignancy or presence of leptomeningeal disease (i.e., positive cerebrospinal fluid cytology or unequivocal radiological or clinical evidence of leptomeningeal involvement) .
- Participants with gastrointestinal conditions that may compromise oral absorption such as short bowel syndrome or active tumor-related bowel obstruction with ongoing symptoms compromising absorption over last 6 months.

Both

Advanced solid tumors

Participants will take BAY2965501 until the tumor gets worse (also known as disease progression).

- Number of participants with treatment - emergent adverse events ( TEAEs ) including treatment - emergent serious adverse events ( TESAEs ) and their severity [ Time Frame : Up to 90 days after the last administration of study treatment ]
- Number of participants experiencing dose - limiting to xicities ( DLTs ) at each dose level in the dose escalation part of the study [ Time Frame : From first dose of study treatment to the end of Cycle 1 ]
- Recommended Phase 2 dose ( RP2D ) of BAY2965501 [ Time Frame : Up to 90 days after the last administration of study treatment ]
- Maximum concentration ( Cmax ) of the respective dosing interval of BAY2965501 after single dose [ Time Frame : From pre - dose up to 24 hours after administration on Cycle 1 Day 1 ]
- Area under the curve [ AUC ( 0 - 24 ) ] for once daily ( QD ) dosing of BAY2965501 after single dose in Cycle 1 [ Time Frame : From pre - dose up to 24 hours after administration on Cycle 1 Day 1 ]
If AUC ( 0 - 24 ) and AUC ( 0 - 12 ) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC ( 0 - tlast ) as primary variable.
- Area under the curve [ AUC ( 0 - 12 ) ] for 2 times daily ( BID ) dosing after single dose in Cycle 1 ( if applicable ) [ Time Frame : From pre - dose up to 24 hours after administration on Cycle 1 Day 1 ]
If AUC ( 0 - 24 ) and AUC ( 0 - 12 ) cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC ( 0 - tlast ) as primary variable.
- Maximum concentration ( Cmax, md ) of the respective dosing interval of BAY2965501 after multiple dose [ Time Frame : From pre - dose up to 24 hours after administration on Cycle 1 Day 15 ]
- Area under the curve [ AUC ( 0 - 24 ) md ] for QD dosing of BAY2965501 after multiple dose [ Time Frame : From pre - dose up to 24 hours after administration on Cycle 1 Day 15 ]
If AUC ( 0 - 24 ) md, AUC ( 0 - 12 ) md cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC ( 0 - tlast ) md as primary variable.
- Area under the curve [ AUC ( 0 - 12 ) md ] for BID dosing of BAY2965501 after multiple dose ( if applicable ) [ Time Frame : From pre - dose up to 24 hours after administration on Cycle 1 Day 15 ]
If AUC ( 0 - 24 ) md, AUC ( 0 - 12 ) md cannot be calculated reliably, it might become necessary to appoint the additional parameter AUC ( 0 - tlast ) md as primary variable.

+81-3-3542-2511

Feb. 28, 2023

No

US/UK