Actively Recruiting
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
Led by AstraZeneca · Updated on 2026-04-06
304
Participants Needed
20
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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+.
CONDITIONS
Official Title
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Tumor tests positive for GPC3 by a central laboratory using a validated IHC assay
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group Performance Status of 0 or 1 at screening
- Predicted life expectancy of at least 12 weeks
- Adequate organ and bone marrow function within 28 days prior to first dose
- Use of contraception by men or women according to local regulations
- Confirmed advanced, recurrent, metastatic, or unresectable hepatocellular carcinoma based on WHO criteria
- Barcelona Clinic Liver Cancer stage B (not eligible for locoregional therapy) or stage C
- Child-Pugh Score class A
- For Part A: At least one prior line of standard systemic therapy for HCC
- For Part B: No more than one prior line of systemic therapy in advanced or metastatic setting
You will not qualify if you...
- Unresolved toxicity from prior anticancer therapy of Grade 2 or higher, except certain controlled conditions
- Participation in another clinical trial with an investigational product within 21 days or 5 half-lives before enrollment
- CAR-T cell therapy within 6 months prior to enrollment
- Known allergy or hypersensitivity to AZD9793 or its excipients
- Need for chronic immunosuppressive therapy including steroids over 10 mg prednisone/day or equivalent
- Radiation therapy within 14 days prior to first dose, except palliative radiation for bulky disease
- Major surgery within 14 days prior to first dose
- History of severe cytokine release syndrome or neurotoxicity from prior T cell engager or CAR-T therapy
- History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- Active or prior autoimmune or inflammatory disorders within 3 years before treatment start
- Certain cardiac conditions as defined by the protocol
- Thromboembolic event within 3 months prior to first dose
- Central nervous system metastases or pathology within 3 months prior to consent
- Active infections including HIV and uncontrolled systemic fungal or bacterial infections
- Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular malignant cholangiocarcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Research Site
La Jolla, California, United States, 92093
Not Yet Recruiting
2
Research Site
Los Angeles, California, United States, 90089
Not Yet Recruiting
3
Research Site
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
4
Research Site
St Louis, Missouri, United States, 63108
Actively Recruiting
5
Research Site
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
6
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
7
Research Site
Chengdu, China, 610041
Not Yet Recruiting
8
Research Site
Guangzhou, China, 510515
Actively Recruiting
9
Research Site
Harbin, China, 150049
Not Yet Recruiting
10
Research Site
Shanghai, China, 201114
Actively Recruiting
11
Research Site
Pokfulam, Hong Kong, 999077
Not Yet Recruiting
12
Research Site
Shatin, Hong Kong, 000000
Actively Recruiting
13
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
14
Research Site
Yokohama, Japan, 241-8515
Actively Recruiting
15
Research Site
Seoul, South Korea, 06351
Not Yet Recruiting
16
Research Site
Seoul, South Korea, 5505
Actively Recruiting
17
Research Site
Barcelona, Spain, 8035
Not Yet Recruiting
18
Research Site
Pamplona, Spain, 31008
Not Yet Recruiting
19
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
20
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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