BridgeMD
A trial to learn how safe AZD9793 is, how it moves throughout the body over time, how it affects the body, and how well it works in adults with advanced or metastatic solid tumors
EU CTIS ID: 2024-516698-56-00
What this study is testing
To investigate the safety and tolerability, and determine the Maximum Tolerated Dose (MTD), Optimal Biological Dose (OBD), and/or Recommended Dose(s) for Expansion (RDEs), as well as the Recommended Phase 2 Dose(s) (RP2Ds), of AZD9793 monotherapy, and to evaluate its preliminary anti‑tumour activity in participants with advanced or metastatic solid tumours with GPC3 expression
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 at the time of signing the informed consent
- Child-Pugh Score class A.
- Previous therapy: Part A: Patients who have received at least one prior line of standard systemic therapy for HCC as per NCCN or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and/or tolerability and/or patient/investigator decision.
- Previous therapy: Part B: Patients must not have received more than 1 prior line of systemic therapy in the advanced recurrent and/or metastatic setting.
- 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
You likely can't join if
- Unresolved toxicity from prior anticancer therapy, including irAEs, 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.
- Cardiac conditions as defined by the protocol.
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
- Central nervous system (CNS) pathology or symptomatic or clinically unstable CNS metastases, as defined by the protocol, within 3 months prior to consent.
- Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
- 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.
See the full eligibility criteria
Who can join
- Age ≥ 18 at the time of signing the informed consent
- Child-Pugh Score class A.
- Previous therapy: Part A: Patients who have received at least one prior line of standard systemic therapy for HCC as per NCCN or other local scientific guidelines and for which a clinical study is the best option for next treatment based on prior response and/or tolerability and/or patient/investigator decision.
- Previous therapy: Part B: Patients must not have received more than 1 prior line of systemic therapy in the advanced recurrent and/or metastatic setting.
- 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
- Predicted life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol.
- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol.
- Confirmed advanced recurrent and/or metastatic and/or unresectable HCC, which is histopathologically proven based on the criteria established by the World Health Organization.
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
What rules you out
- Unresolved toxicity from prior anticancer therapy, including irAEs, 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.
- Cardiac conditions as defined by the protocol.
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
- Central nervous system (CNS) pathology or symptomatic or clinically unstable CNS metastases, as defined by the protocol, within 3 months prior to consent.
- Infectious disease including active human immunodeficiency virus (HIV), and uncontrolled active systemic fungal, bacterial or other infection.
- 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.
- Requires chronic immunosuppressive therapy (including steroids > 10 mg prednisone/day or equivalent)
- Received radiation within 14 days prior to first dose of study treatment; palliative radiation to reduce the risk of tumour lysis syndrome (TLS) or CRS/neurotoxicity in participants with bulky disease is permitted
- Undergone a major surgical procedure within 14 days to allow adequate healing
- Experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy.
- Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS).
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Japan
- Taiwan
- United States
- China
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Japan; Taiwan; United States; China; Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.