Actively Recruiting
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
Led by InSilico Medicine Hong Kong Limited · Updated on 2025-12-11
80
Participants Needed
9
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.
CONDITIONS
Official Title
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at informed consent
- Histologically confirmed unresectable locally advanced or metastatic solid tumors with homozygous MTAP deletion
- Disease progression after standard therapy, intolerance to standard therapy, or no existing standard therapy
- Measurable or evaluable lesions in Part 1; at least one measurable target lesion in Part 2 per RECIST criteria
- Provide documented evidence of homozygous MTAP deletion or tumor tissue samples for confirmatory testing
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 1 or less
- Life expectancy of at least 12 weeks as judged by the investigator
- Adequate organ function per medical assessment
- Ability to sign informed consent and comply with study requirements and restrictions
You will not qualify if you...
- Previous treatment with MAT2A inhibitors and/or PRMT inhibitors
- Participation in other therapeutic clinical studies within 28 days or 5 half-lives prior to first study dose
- Anti-tumor therapy (chemotherapy, immunotherapy, hormonal, targeted, biologic therapies) within 28 days or 5 half-lives prior to first dose, except specific hormone therapies
- Unresolved toxicities from prior therapies above Grade 1 or baseline per NCI CTCAE v5.0
- History of another primary tumor diagnosed or treated within the past 3 years
- History of Gilbert's syndrome
- History of myelodysplastic syndrome
- Prior solid organ or hematopoietic stem cell transplant
- Known active central nervous system primary tumor or untreated CNS metastases
- Serious cardiovascular or cerebrovascular disease
- Uncontrolled systemic infection
- Unwillingness or inability to take oral medication or presence of gastrointestinal conditions preventing this
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
2
Smilow Cancer Hospital at Yale New Haven Breast Center
New Haven, Connecticut, United States, 06520-8028
Actively Recruiting
3
Community Cancer Center North
Indianapolis, Indiana, United States, 46250-2042
Actively Recruiting
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
Actively Recruiting
6
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
7
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China, 510030
Actively Recruiting
8
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
9
Shanghai Gobroad Cancer Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
R
Rebecca Griffith
CONTACT
R
Rebecca Griffith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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