Clinical trial · Interventional
Phase 1 First-in-human Study of JS014
A Phase 1 Study of JS014, a Recombinant Fusion Protein of Interleukin-21 and Humanized Anti-human Serum Albumin VHH Antibody as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Cancer
NCT05296772CI-TRIAL-00069366unknownPhase 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 phase 1, first-in-human study uses a BOIN design to assess the safety and potential efficacy of JS014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasm, Experimental | Neoplasm | ONTOLOGY_EXACT | 0.85 |
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody | Biological | — | UNRESOLVED |
| Pembrolizumab - anti-PD-1 antibody | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Dose escalation
- description
- A open-label single arm of JS014 alone or in combination with pembrolizumab
- interventionNames
- Biological: JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody
- Biological: Pembrolizumab - anti-PD-1 antibody
Primary outcomes (3)
- measure
- The numbers of participants with treatment-related adverse events assessed by CTCAE 5.0
- timeFrame
- 24 months
- description
- To determine the percentage of various toxicities assessed by CTCAE at different dose levels alone or in combination with pembrolizumab
- measure
- Maximum tolerated dose (MTD) of JS014
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Older 18 years of age or per local regulation * Subjects with advanced cancer or lymphoma who have no standard therapy available, ineligible for standard therapy or unwilling to receive cytotoxic therapy . * ECOG PS 0-1 * A life expectancy longer than three months * Adequate organ functions * Able to adopt effective contraceptive measures Exclusion Criteria: * Known history of allergies to JS014 or IL-21 or human serum albumin or pembrolizumab (Ib only) * Subjects who have received major surgery less than 4 weeks before 1st infusion of JS014 * Subjects who has a history of immune-related adverse events in prior immunotherapy. * Subjects who have received immunosuppressive therapy less than 4 weeks before 1st infusion of JS014. * Subjects who have two or more primary cancers in the past 5 years. * Newly diagnosed or symptomatic brain metastases. * Subjects who have received prior anti-cancer therapy with residual toxicities greater than grade 2. * Subjects who have a history of autoimmune disease in 2 years. * Subjects who have active infection, or uncontrollable hypertension, unstable angina, active peptic ulcer, recent acute myocardial infarction, severe congestive heart failure, or unhealed wound. * Subjects with active hepatitis B or hepatitis C. * Subjects who are pregnant or breast feeding. * Subjects who primary immune deficiency.
References
Publications (0)
Data not yet available
No reference posted for this study.