Clinical trial · Interventional
A Study of DS3610a in Participants With Advanced Solid Tumor
A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor
NCT07159126CI-TRIAL-00098738recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DS3610a | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DS3610a at Escalating Doses
- description
- Participants will receive DS3610a at escalating doses. The RDE will be determined using data collected from this arm.
- interventionNames
- Drug: DS3610a
Primary outcomes (1)
- measure
- Dose Limiting Toxicities
- timeFrame
- From first dose, up to approximately 24 months
Secondary outcomes (2)
- measure
- Area Under the Blood Concentration-time Curve During Dosing Interval
- timeFrame
- From baseline to postbaseline, up to approximately 36 months
- description
- Area Under the Blood Concentration-time Curve During Dosing Interval (AUCtau) will be used to asses PK parameters
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Sign and date the main ICF, prior to the start of any trial-specific procedures. * Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). * Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and/or investigator. * Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample. * Has measurable disease based on local CT/MRI imaging as assessed by the investigator per RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention. Key Exclusion Criteria: \*Inadequate washout period before initiation of trial intervention, defined as: Major surgery: ≤4 weeks (or ≤2 weeks for low-invasive cases) Curative radiation therapy: ≤4 weeks Chemotherapy, Ab-based anticancer therapy, immunotherapy: ≤4 weeks Small molecules (eg, tyrosine kinase inhibitors): ≤2 weeks or 5 half-lives, whichever is longer Nitrosoureas: ≤6 weeks * Has known symptomatic CNS metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable. MRI/CT of the brain is required for all participants during SCR Period * Uncontrolled or clinically significant cardiovascular disease, including the following: 1. Myocardial infarction within 6 months prior to SCR. 2. Uncontrolled angina pectoris within 6 months prior to SCR. 3. New York Heart Association (NYHA) Class III or IV CHF. 4. LVEF ≤50%. 5. QTcF interval \>470 ms. * Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic events. * Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen) resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
References
Publications (0)
Data not yet available
No reference posted for this study.