A pill aimed at a specific gene flaw in Hard-to-Treat tumors
NCT ID NCT07071090
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing an experimental tablet called DC50292A in adults with advanced or metastatic solid tumors that have lost a gene called MTAP and have not responded to standard treatments. The trial has two parts: one to find a safe dose and another to give that dose to more patients. The main goal is to see whether the drug is safe and tolerable, while also checking how the body processes it and whether tumors show any early signs of shrinking.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DC50292A, an experimental tablet drug
- What this could lead to
- If DC50292A proves safe and shows early signs of activity, it could become a targeted option for people whose tumors have lost the MTAP gene and who have run out of standard treatments.
- What could go wrong
- This is a first-in-human phase I trial with only 32 participants, so its main goal is to check safety and dosing, not to prove the drug works. Many experimental cancer drugs fail at this stage, and side effects may be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily signs the informed consent form, demonstrates understanding of the study, and is willing and able to comply with all trial procedures. 2. Age ≥18 years, regardless of gender. 3. Patients with histologically and/or cytologically confirmed solid tumors who are assessed by the investigator as having locally advanced, recurrent, or metastatic disease and have failed standard treatments at the current stage. 4. At least one measurable lesion as per RECIST v1.1 criteria, assessed via imaging (tumor lesions located in previously irradiated areas or those having undergone other local-regional therapies are generally not considered measurable unless clear progression is confirmed by the investigator). 5. MTAP deficiency, defined by one of the following: willingness to provide sufficient archived tumor tissue or fresh biopsy samples for MTAP testing; or documentation of MTAP homozygous deletion via NGS/IHC or loss of MTAP protein expression in tissue; or availability of a prior NGS report (within 3 years) confirming MTAP homozygous deletion or an IHC report confirming loss of MTAP expression, as accepted by the investigator. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Life expectancy ≥3 months. 8. Absence of severe hematological, hepatic, renal, coagulation, or cardiac dysfunction. 9. Male and female participants of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Female participants of childbearing potential must have a negative serum pregnancy test result prior to the first dose of the study medication. Exclusion Criteria: 1. Received chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, including: nitrosoureas or mitomycin C within 6 weeks prior; oral fluoropyrimidines or small-molecule targeted agents within 2 weeks or 5 half-lives (whichever is shorter); Chinese herbal medicines with antitumor indications within 2 weeks prior. 2. Received any non-marketed investigational drugs or therapies within 4 weeks prior to the first dose. 3. Undergone major organ surgery (excluding needle biopsy or surgery for pathologic fractures), significant trauma, or planned elective surgery during the trial within 4 weeks prior. 4. Used CYP3A4-sensitive substrates, strong inhibitors/inducers, CYP2C8-sensitive substrates, or P-gp inhibitors (see Appendix 3) within 14 days or 5 half-lives (whichever is shorter) prior. 5. Previously treated with PRMT5 or MAT2A inhibitors. 6. QTc interval ≥480 ms (mean of 3 measurements) on screening/baseline 12-lead ECG. 7. Prior allogeneic hematopoietic stem cell/bone marrow transplantation or solid organ transplantation, or current use of immunosuppressants/anti-rejection drugs. 8. Known allergy to any active/inactive ingredient of the study drug. 9. Adverse reactions from prior antitumor therapy not resolved to CTCAE v5.0 Grade ≤1 (except non-risks like alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism on hormone replacement). 10. Hepatitis B (HBsAg+ with HBV-DNA ≥2500 copies/mL or 500 IU/mL), HCV (HCV-RNA \> lower limit of detection), HIV-positive, or syphilis (both specific/non-specific antibodies positive). 11. Symptomatic/active CNS metastases, leptomeningeal disease, or spinal cord compression. Asymptomatic CNS metastases may enroll if: 1. Measurable extracranial lesions per RECIST v1.1; 2. No new/progressive CNS lesions for ≥4 weeks with stable neurologic symptoms; 3. No seizures/increased intracranial pressure; 4. No steroids/antiepileptics/dehydrants for ≥2 weeks. 12. Clinically significant third-space fluid accumulation (e.g., massive ascites/pleural effusion). 13. Cardiovascular Disease: severe arrhythmias (e.g., ventricular arrhythmias requiring intervention, AV block II-III); ACS, CHF, aortic dissection, stroke, or Grade ≥3 cardiovascular events within 6 months; NYHA Class ≥II or high-risk structural heart disease; uncontrolled hypertension (SBP ≥150 mmHg and/or DBP ≥95 mmHg); QTc prolongation risks (e.g., heart failure, uncorrected hypokalemia, congenital/family history of long QT syndrome, concomitant QT-prolonging drugs). 14. Systemic treatment for active infection within 4 weeks prior. 15. Acute esophageal/GI diseases affecting drug absorption (e.g., bowel obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome). 16. Pulmonary Disease: interstitial lung disease (ILD), pulmonary fibrosis, or drug-induced pneumonitis requiring treatment. 17. Other Severe Conditions: hepatic, renal, neurologic/psychiatric, endocrine, hematologic, or immune disorders compromising study participation. 18. Other malignancies within 5 years (except cured malignancies like basal/ squamous cell skin cancer, low-risk prostate cancer, papillary thyroid cancer, or excised in situ cancers). 19. Known alcohol/drug dependence. 20. Psychiatric disorders or poor adherence. 21. Pregnant or breastfeeding women. 22. Investigator's Discretion: any other clinical/laboratory abnormalities deemed unsuitable for the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Cancer Hospital
RECRUITINGFuzhou, Fujian, China
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Guangxi Medical University Cancer Hospital
RECRUITINGNanning, Guangxi, China
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Harbin Medical University Cancer Hospital
RECRUITINGHarbin, Heilongjiang, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, China
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Shandong Cancer Hospital
RECRUITINGJinan, Shandong, China
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Sir Run Run Shaw Hospital
RECRUITINGHangzhou, Zhejiang, China
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Sun Yat-Sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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