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Clinical Trial 20258

Cancer Type: Immunotherapy
Study Type: Treatment
NCT#: NCT04128423

Phase: Phase I
Prinicipal Investigator: Michael Shafique

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Study Title

A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 Alone and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors


This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.


The primary objective of the dose-escalation stage of the study is: To characterize the safety profile and tolerability of AMV564, including cumulative toxicities -to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of AMV564 in patients with locally advanced or metastatic solid tumors The primary objectives of the dose-expansion stage of the study are: -to further characterize the safety and tolerability of AMV564 at the MTD/RP2D -to evaluate preliminary efficacy of AMV564 at the MTD/RP2D The secondary objectives of this study are: -to evaluate the pharmacokinetic (PK) profile of AMV564 -to assess the pharmacodynamics, immune response, and preliminary disease response/clinical activity of AMV564 Exploratory Objectives: -to determine the relationship between AMV564 PK and drug effects, including efficacy and safety -to evaluate potential predictive biomarkers for response -to evaluate potential predictive biomarkers for resistance




AMV564 (); Pembrolizumab (Keytruda)

Inclusion Criteria

  • 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status > Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard therapy exists
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or per other criteria best suited for the specific tumor type being evaluated
  • Willing to complete all scheduled visits and assessments at the institution administering therapy
  • Expansion Cohort Inclusion Criteria (note: subjects may be enrolled into any expansion cohort for which they qualify, provided they meet all other inclusion/exclusion criteria):
  • Cohort 1: Histologically or cytologically documented extensive stage small cell lung cancer (SCLC) after no more than 1 prior line of systemic therapy for advanced or metastatic disease
  • Cohort 2: Histologically or cytologically documented Merkel cell carcinoma after at least 1 prior line of therapy for advanced or metastatic disease
  • Cohort 3: Histologically or cytologically documented recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after platinum-based treatment regimen and at least 1 prior therapy for recurrent disease
  • Cohort 4: Histologically or cytologically documented recurrent, unresectable, or metastatic (with no surgical, radiation, or other local therapy options) squamous cell carcinoma with primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx (primary tumor site of nasopharynx are excluded) after at least 1 prior line of therapy for advanced or metastatic disease
  • Cohort 5: Histologically or cytologically documented advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter (upper urinary tract), bladder, or urethra with transitional cell carcinoma as the predominant histology after at least 1 prior line of therapy for advanced or metastatic disease
  • Cohort 6: Histologically or cytologically documented renal cell carcinoma with clear cell component (with or without sarcomatoid features) after no more than 3 prior lines of therapy for advanced or metastatic disease
  • Cohort 7: Solid tumor (excluding glioma) locally confirmed to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) using polymerase chain reaction (PCR) or immunohistochemistry (IHC) after at least 1 prior line of therapy for advanced or metastatic disease
  • Cohort 8: Solid tumor (excluding colorectal, gastric, esophageal, neuroblastoma, pancreatic adenocarcinoma, and prostate tumors unless there is a documented POLE or POLD1 mutation) with plasma tumor mutational burden (TMB):
  • Cohort 8a: > Cohort 8b: >10 mutations/megabase (TMB high)

  • Exclusion Criteria

  • Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of AMV564
  • Major trauma or major surgery within 4 weeks prior to first dose of AMV564
  • Prior treatment with chimeric antigen receptor (CAR) T-cell therapy or T-cell engager therapy
  • Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of AMV564
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade > Known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3 drug-related CNS toxicity

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.