First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.

Eligibility criteria

Qualifiers

Age ≥ 18 at the time of signing the informed consent.

GPC3 positive tumour as determined by a central laboratory using an analytically validated IHC assay. Patients who previously received any therapy targeting GPC3 must undergo central laboratory GPC3 testing on tumour tissue collected after completion of the prior GPC3-targeted therapy.

Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening.

Disqualifiers

Unresolved toxicity from prior anticancer therapy, including imAEs, of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for vitiligo, peripheral neuropathy related to prior anti-cancer therapy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities.

Prior to enrolment, participation in another clinical study with an investigational product administered in the last 21 days or 5 half-lives whichever is shorter.

CAR-T cell therapy within the last 6 months prior to enrolment on this study.

Known allergy or hypersensitivity to AZD9793 or any of the excipients of the product as outlined in the IB.

Trial design

Treatments tested in this trial

  • AZD9793 Intravenous (IV) monotherapy
  • AZD9793 Subcutaneous (SC) monotherapy

Treatment groups

304 Participants
are divided into 4 treatment groups

Sponsors and collaborators