Clinical trial · Interventional
Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
A Multi-center, Phase I, Open Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.
- 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 is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
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 Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TWP-102 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Cohort
- description
- Four dose levels of TWP-102 injection will be tested by BOIN study design.
- interventionNames
- Drug: TWP-102 injection
- type
- EXPERIMENTAL
- label
- Dose Expansion Cohort
- description
- Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.
- interventionNames
- Drug: TWP-102 injection
Primary outcomes (2)
- measure
- Incidence of adverse events/serious adverse event related with TWP-102 injection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments; * At least 1 measurable lesion. * ECOG score 0 or 1; * Life expectancy of ≥ 3 months; Exclusion Criteria: * Known hypersensitivity to any ingredient of TWP-102; * Receiving any anti-cancer drugs within 4 weeks; * History of serious systemic diseases; * History of serious autoimmune diseases; * Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \> 1 severity that is related to prior anti-cancer therapy. (except alopecia) * Pregnancy or lactating women.
References
Publications (0)
Data not yet available