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Two Parts:

Part A: 14C-labeled OSI-906

Part B: (Optional) OSI-906 (non-labeled)

radio-labeled OSI-906

OSI-906

Medical Director

The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906. Subjects with Advanced Solid Tumors may participate and then continue into the Optional Treatment Phase.

This study includes two parts: Part A

Subjects will be admitted to the clinical research unit on Day -1 and remain confined to the unit until post dosing discharge criteria are met up to a maximum of 10 days. On Day 1, subjects will receive a single oral dose of 14C-labeled OSI-906.

Part B (optional)

Once the subject has completed part A, the subject may elect to continue participation in Part B. Subjects will receive OSI-906 (non-radiolabeled) twice daily by mouth. Subjects will be seen for scheduled visits every 7 days for the first 36 days and then every 21 days.

A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body

A Phase 1, Open-label Study to Investigate the Absorption, Metabolism, and Excretion of 14C-OSI-906 in Subjects With Advanced Solid Tumors With an Optional Treatment Phase

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Outcome measure for Part A: Area under the time concentration curve extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable time point (AUClast), Maximum Plasma Concentration (Cmax), Time to maximum concentration (Tmax), Terminal half-life (t 1/2), Apparent Body Clearance after dosing (CL/F), and Apparent volume of distribution (Vz/F)

Outcome Measure for Part A of OSI-906 distribution between cellular components and plasma

Astellas Pharma Global Development, Inc.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Amino Acids

Dacomitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Single 45 mg oral dose of \[14C\]PF-00299804

Single 45 mg oral dose of radiolabelled PF-00299804

[14C]PF00299804

Pfizer CT.gov Call Center

This is single dose study of radiolabeled \[14C\]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804.

A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers

A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C]PF-00299804 in Healthy Male Volunteers

Syneos Health

Pfizer

Director, Clinical Trial Disclosure Group

Nervous System Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Immune System Diseases

Rare Diseases

Ataxia

Cerebellar Ataxia

Telangiectasis

Ataxia Telangiectasia

Antineoplastic Agents

Topotecan

Topoisomerase I Inhibitors

Participants will receive single intravenous infusion of \[14C\]M6620 on Day 1 in Period 1 and stay in clinical research unit (CRU) is required until the discharge criteria are met with a maximum confinement period of 15 days.

[14C]M6620

Participants will receive intravenous infusion of M6620 on Day 2 and Day 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation are met.

M6620

Participants will receive intravenous infusion of topotecan on Day 1 through Day 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation are met.

Medical Responsible

The study will be conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study is to provide a quantitative characterization of the mass balance, rates and routes of elimination, and metabolic pathways after a single intravenous administration of \[14C\]berzosertib. The purpose of Period 2 is to assess safety and efficacy of berzosertib in combination with topotecan.

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Phase I Study to Evaluate the Mass Balance, PK, Metabolism and Excretion of Berzosertib (Intravenous) Containing Microtracer [14C]Berzosertib in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 208)

Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body	NCT01529684	Advanced Solid ... Pharmacokinetic...	radio-labeled O... OSI-906	18 Years -	Astellas Pharma Inc
A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers	NCT01034748	Carcinoma, Non-...	[14C]PF00299804	18 Years - 55 Years	Pfizer
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)	NCT05246111	Advanced Solid ...	[14C]M6620 M6620 Topotecan	18 Years -	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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