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RecruitingLast updated: 2 February 2024

This study is evaluating how safe and tolerable different doses of a new targeted therapy (AMG 305) are in people with advanced solid cancerPhase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Clinical summary

Summary

This study has two parts. In Part A (dose exploration), participants will receive escalating doses of AMG 305 which will be administered via short-term intravenous infusion (IV). This part seeks to establish the recommended phase 2 dose (RP2D) of AMG 305. In Part B (dose expansion), participants with non-small cell lung cancer, colorectal cancer, pancreatic cancer and other solid cancers will receive the RP2D of AMG 305 that was identified in Part A.

Conditions

This trial is treating patients with advanced solid cancers expressing cadherin-3 and mesothelin

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 100

Phase

I

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

Eligibility

Inclusion

Pre-screening:

  • Participant has provided informed consent prior to initiation of any pre screening study specific activities/procedures.
  • Participants with histologically or cytologically documented solid tumor diseases expressing cadherin-3 and mesothelin (by mRNA in the Cancer Genome Atlas Program [TCGA] database), including CRC, NSCLC, mesothelioma, pancreatic cancer, gastric cancer, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer

Clinical study:

  • Participant has provided inform consent to the main study prior to initiation of any study specific activities/procedures
  • Male or female participants age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Participants with histologically or cytologically documented solid tumor diseases, including CRC, NSCLC, mesothelioma, pancreatic cancer, GC, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
  • For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
  • Life expectancy > 3 months
  • Adequate organ function

Exclusion

  • Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
  • History of other malignancy within the past 2 years
  • Ongoing or active infection
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Known interstitial lung disease
  • Positive test for human immunodeficiency virus (HIV)
  • Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
  • Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks or 5 half lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment.
  • Has had a major surgery within 4 weeks of administration of a first dose of study treatment
  • Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
  • Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305
  • Currently receiving treatment in another investigational device or drug study
  • Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
  • Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
  • History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.