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Clinical Trials List

Protocol Number20210023
NCT Number(ClinicalTrials.gov Identfier)NCT05094336
Active

2021-11-01 - 2027-03-20

Phase I/II

Recruiting4

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ping Hung Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Chang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced MTAP-null Solid Tumors

Objectives

This is a FIH, multicenter, open-label, phase 1/1b/2 trial investigating the safety, tolerability, pharmacokinetic (PK), disease progression (PD), and efficacy of AMG 193 alone or in combination with docetaxel in adult patients with advanced MTAP-deficient solid tumors. AMG 193 is administered orally once daily (QD) continuously or intermittently. The trial will be conducted in three parts, each further divided into sub-parts, as described below. Phase 1 AMG 193 Monotherapy Dose Escalation (Parts 1a or 1b) Parts 1a and 1b will allow for dose exploration of AMG 193 monotherapy for MTAP-deficient solid tumors: Continuous dosing in 4-week cycles (Part 1a), or intermittent dosing in 3-week cycles (2 weeks on, 1 week off) (Part 1b) Phase 1 AMG 193 Monotherapy Dose Expansion (Parts 1c to 1h) After determining the Phase 2 Recommended Dose 2D (RP2D) and/or Maximum Tolerated Dose Deficit (MTD), dose expansion of AMG 193 will be initiated for the following populations: MTAP-deficient squamous non-small cell lung cancer (NSCLC) (Part 1c), MTAP-deficient adenocarcinoma NSCLC (Part 1d), MTAP-deficient biliary tract cancer (BTC) (Part 1e), MTAP Part 1f: Head and neck squamous cell carcinoma (HNSCC) lacking MTAP, MTAP-deficient pancreatic duct adenocarcinoma lacking MTAP (Part 1g), and MTAP-deficient solid tumors other than squamous or adenocarcinoma NSCLC, BTC, HNSCC, pancreatic duct adenocarcinoma, primary brain tumors, and lymphoma (Part 1h). Phase 1: AMG 193 Dose Escalation with Combination Therapy (Parts 2a and 2b) Part 2 will explore the dose of AMG 193 combined with docetaxel for MTAP-deficient NSCLC (Part 2a), followed by dose escalation of AMG 193 and docetaxel for MTAP-deficient NSCLC (Part 2b). Phase 2 (Part 3) Part 3 is a Phase 2 study of AMG 193 for MTAP-deficient NSCLC. The trial design will be provided in a future revision.

Test Drug

錠劑

Active Ingredient

AMG 193

Dosage Form

110

Dosage

5, 20, 100 mg

Endpoints

Primary Assessment Measure

Parts 1 and 2
Evaluate the safety and tolerability of AMG 193 alone or in combination with docetaxel in adult subjects with metastatic or locally advanced MTAP-deficient solid tumors, and determine their MTD or RP2D.

Part 3

• Evaluate the efficacy of AMG 193 in adult subjects with metastatic or locally advanced MTAP-deficient solid tumors.

Inclution Criteria

Inclusion Criteria:

Participant has provided informed consent/assent before initiation of any study specific activities/procedures.
Age ≥ 18 years.
Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b).
Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product.
Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Note: except participants enrolling to Part 1m.

Exclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

Adequate hematopoietic function per local laboratory
Adequate renal function per local laboratory
Adequate glucose control per local laboratory (Part 1 only)
Adequate liver function per local laboratory
Adequate coagulation parameters
Adequate pulmonary function
Adequate cardiac function
Minimum life expectancy of 12 weeks as per investigator judgement.
Archived tumor tissue (formalin-fixed, paraffin-embedded [FFPE] sample collected within 5 years) or an archival block must be available.
For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy.
For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment.
For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only).

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    527 participants

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