Actively Recruiting
An Open-Label Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Effects of DC50292A Tablets in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Led by Heronova Pharmaceuticals · Updated on 2025-07-23
32
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetic profile, and early effects of DC50292A tablets in patients with MTAP-deficient advanced or metastatic solid tumors. This open-label, non-randomized Phase I study aims to find the best dose and gather initial efficacy data. The trial is sponsored by Heronova Pharmaceuticals and includes two parts: dose escalation and dose expansion phases. In the dose escalation phase, participants receive increasing doses of DC50292A tablets starting from 40 mg up to 900 mg, with study groups planned for six dose levels. This phase includes a single dose followed by pharmacokinetic blood sampling and then daily dosing for three weeks with breaks for toxicity assessment. The dose expansion phase will follow to further evaluate two selected doses up to the maximum tolerated dose, with participants receiving daily oral treatment in 4-week cycles until stopping criteria are met. Participants will be closely monitored with blood samples taken for pharmacokinetic and pharmacodynamic analysis, along with safety assessments over 12 months. Researchers will track adverse events and measure tumor response and progression-free survival. Treatment may continue until disease progression, intolerable side effects, or other study-defined reasons. The total duration of follow-up and treatment varies depending on individual response and study phase.
CONDITIONS
Brief Title
A Study of DC50292A Tablet in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Voluntarily signs informed consent and can follow all trial procedures
- Diagnosed with locally advanced, recurrent, or metastatic solid tumors that have failed standard treatments
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Confirmed MTAP deficiency by appropriate testing or documented reports
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- No severe blood, liver, kidney, coagulation, or heart dysfunction
- Agree to use effective contraception during and for 3 months after treatment if of childbearing potential
- Negative pregnancy test for females of childbearing potential prior to first dose
You will not qualify if you...
- Received chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy, or antitumor treatments within 4 weeks or 5 half-lives before the study drug
- Received non-marketed investigational drugs within 4 weeks prior to study drug
- Major organ surgery or significant trauma within 4 weeks prior to study
- Used certain enzyme-sensitive drugs or inhibitors within 14 days before study drug
- Prior treatment with PRMT5 or MAT2A inhibitors
- QTc interval 480 ms or more on screening ECG
- Previous stem cell or organ transplant or current immunosuppressant use
- Allergy to any component of the study drug
- Unresolved adverse reactions from prior cancer treatments above certain grades
- Active infections including specific viral infections like hepatitis B, C, HIV, or syphilis
- Symptomatic or active central nervous system metastases or spinal cord compression
- Significant fluid accumulation such as massive ascites or pleural effusion
- Severe cardiovascular diseases including arrhythmias, heart failure, uncontrolled hypertension, or QT prolongation risk factors
- Recent systemic treatment for active infection
- Acute digestive diseases affecting drug absorption
- Pulmonary diseases like interstitial lung disease or drug-induced pneumonitis
- Severe other medical conditions affecting participation
- Other malignancies within 5 years except certain cured cancers
- Known alcohol or drug dependence
- Psychiatric disorders or poor adherence
- Pregnant or breastfeeding women
- Any other clinical or lab abnormalities deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until discontinuation criteria
Participants receive escalating doses of DC50292A tablets starting with a single dose followed by daily dosing in cycles to assess safety, tolerability, and preliminary effects until disease progression or other discontinuation criteria are met.
Multiple visits for dosing and assessments during each treatment cycle
Trial Site Locations
Total: 8 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
3
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
7
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
8
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
K
Kang Ren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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