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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.

Primary Objective:

Parts 1 and 2:
- To evaluate the safety, tolerability, and to determine the MTD or RP2D of AMG 193 alone and in combination with docetaxel in adult subjects with metastatic or locally advanced MTAP-null solid tumors.

Part 3:
- To evaluate the ORR of AMG 193 in adult subjects with metastatic or locally advanced MTAP-null non-small cell lung cancer NSCLC, after prior treatment with chemotherapy and/or a PD-L1 inhibitor.

Secondary Objectives:

Parts 1 and 2:
- To characterize the PK of AMG 193 alone and in combination with docetaxel. To evaluate ORR, DCR, DoR,TTR, duration of SD, PFS, and OS of AMG 193 alone and in combination with docetaxel in adult subjects with MTAP-null solid tumors;

Part 3:
- To assess safety and tolerability of AMG 193 in metastatic or locally advanced MTAP-null NSCLC.

- To evaluate DCR, DoR, TTR, duration of SD, PFS, and OS of AMG 193 in metastatic or locally advance MTAP-null NSCLC.

Protocol Number: 052208
Phase: Phase I
Applicable Disease Sites: Any Site
Drugs Involved: AMG 193
DOCETAXEL
Principal Investigator: Sanjay Goel
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Participating Institutions:
  • RWJBarnabas Health
    • Robert Wood Johnson University Hospital, New Brunswick
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.