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CompletedLast updated: 23 January 2024

GO29313: This phase I trial is assessing an intravenously (in the vein) administered drug (MOXR0916) for the treatment of locally advanced or metastatic solid cancers (excluding blood cancer)A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF MOXR0916 ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT TO PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Clinical summary

Summary

This is a first-in-human, Phase I, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of MOXR091 6 administered intravenously in patients with locally advanced or metastatic sol id tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate. The planned duration of the study is approximately 3 years.

Conditions

This trial is treating patients with advanced solid cancers (excluding blood cancer).

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

GO29313

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Genentech

Scientific Title

A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF MOXR0916 ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT TO PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

Eligibility

Inclusion

  • Histologic documentation of locally advanced, recurrent or metastatic incurable solid malignancy that has progressed after all available standard therapy or for which standard therapy has proven to be ineffective or intolerable, or is considered inappropriate
  • Confirmed availability of representative tumor specimens in paraffin blocks/unstained slides
  • Measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematologic and end organ function
  • For female participants of childbearing potential, agreement to use highly effective form(s) of contraception and to continue its use for 6 months after the last dose of MOXR0916

Exclusion

  • Any anti-cancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment (hormonal therapy with gonadotropin-releasing hormone agonists or antagonists for prostate cancer and palliative radiotherapy greater than (>) 2 weeks prior to Cycle 1, Day 1 are allowed)
  • Eligibility based on prior treatment with immunomodulatory agents depends on the mechanistic class of the drug and the cohort for which the participant is being considered
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade less than or equal to (</=) 1 except for alopecia or endocrinopathy managed with replacement therapy
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
  • Leptomeningeal disease
  • Malignancies other than disease under study within 5 years
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for human immunodeficiency virus infection
  • Active hepatitis B or active hepatitis C
  • Severe infections within 4 weeks or signs or symptoms of infection within 2 weeks prior to Cycle 1
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Significant cardiovascular disease
  • Known clinically significant liver disease

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • 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.
Message

Clinical trials have complex eligibility criteria.

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

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