Clinical trial · Interventional
A Phase I Study of JS108 in Patients With Advanced Solid Tumors
A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor has adjusted study development plan and terminated this clinical study.
Summary
Brief summary (as posted)
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- interventionNames
- Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
Primary outcomes (2)
- measure
- First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
- timeFrame
- A minimum of 21 days after first infusion of study drug
- description
- Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- Through study completion, an average of 1 year
- description
- The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
1. Volunteer to sign an informed consent form. 2. Age of 18-75 years (inclusive), male or female; 3. Expected survival ≥3 months; 4. Histological or cytologically confirmed locally advanced or metastatic solid tumors which progressed on standard of care or with no standard of care available; 5. Toxicity of previous antitumor therapy has recovered to ≤ grade 1 as defined by the NCI-CTCAE v5.0, except alopecia; 6. Subjects dose expansion period and clinical expansion period must have at least one measurable lesion in accordance with RECIST v 1.1; 7. Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0 or 1; 8. Subjects must be able to provide fresh or archived tumor tissue obtained within 1 year prior to inclusion in the study； 9. The organ function level must meet the protocol requirements； 10. Serum pregnancy test confirmed as negative for women of childbearing potential within 7
References
Publications (0)
Data not yet available