Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Biliary Tract Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Docetaxel

Tubulin Modulators

Antimitotic Agents

Arginine

Participants with MTAP-null solid tumors will receive escalating doses of AMG 193 to estimate the MTD and/or the RP2D.

A group of these participants in the United States (US) will have the option to take part in a Drug Substance Particle Size (DSPS) assessment. These participants will receive escalating doses of AMG 193 and a dose of a comparator AMG 193 test tablet.

Participants will receive the identified MTD/RP2D of AMG 193 in the following cohort: MTAP-null or lost MTAP expression NSCLC.

Participants with MTAP-null NSCLC will receive escalating doses of AMG 193 + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination.

Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of AMG 193 + docetaxel.

Participants with MTAP-null solid tumors will receive AMG 193.

Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null BTC.

Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort:

MTAP-null head and neck squamous cell carcinoma (HNSCC)

Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort:

MTAP-null pancreatic adenocarcinoma

Participants will receive the identified selected dose/MTD of AMG 193 in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor).

Participants will receive a randomized dose optimization evaluation of AMG 193.

Participants will receive doses of AMG 193 and comparator AMG 193 test tables at different times in a fasted state.

Participants will receive AMG 193 once on a fasted state and once after eating a standardized high-fat, high calorie meal.

AMG 193

Comparator AMG 193 test tablet: Orally via tablet. Only participants in the DSPS group of the Part 1a, Phase 1: AMG 193 Monotherapy Dose Exploration, and Part 1j, Phase 1 arms will receive comparator AMG 193 test tablet.

Comparator AMG 193 Test Tablet

Amgen Call Center

The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.

The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors.

AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs.

Serious AEs (SAEs) are defined as any event that meets at least 1 of the following serious criteria:

* Results in death (fatal)
* Requires in-patient hospitalization or prolongation of existing hospitalization
* Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect
* Other medically important serious event

AEs are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, ECGs and clinical laboratory tests will be recorded as TEAEs.

SAEs are defined as any event that meets at least 1 of the following serious criteria:

* Results in death (fatal)
* Requires in-patient hospitalization or prolongation of existing hospitalization
* Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect
* Other medically important serious event

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors	NCT05094336	Advanced MTAP-n...	AMG 193 Docetaxel Comparator AMG ...	18 Years - 100 Years	Amgen
AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors	NCT05094336	Advanced MTAP-n...	AMG 193 Docetaxel Comparator AMG ...	18 Years - 100 Years	Amgen

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