Clinical trial · Interventional
Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
A Multi-center, Phase Ia/Ib, Open Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma
NCT04871334CI-TRIAL-00052877unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.
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 |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Advanced Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TWP-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort
- description
- Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.
- interventionNames
- Drug: TWP-101
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort
- description
- Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
- interventionNames
- Drug: TWP-101
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicity (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments * ECOG score 0 or 1; * Part B: At least 1 measurable lesion according to RECIST 1.1 Exclusion Criteria: * Known hypersensitivity to any ingredient of TWP-101; * Receiving any anti-cancer drugs; * History of serious systemic diseases; * History of serious autoimmune diseases; * Pregnancy or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.