Clinical trial · Interventional
Phase I/II Study of SCTB39G in Advanced Solid Tumours
An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39G in Adult Patients With Advanced Malignant Solid Tumours
- 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 aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
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 Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCTB39G | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCTB39G
- description
- SCTB39G of different doses, IV
- interventionNames
- Drug: SCTB39G
Primary outcomes (2)
- measure
- Dose-Limiting toxicity(DLT)
- timeFrame
- From Day 0 up to Day 21
- description
- Incidence of dose-limiting toxicities up to the Day 21 visit
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 2 years
- description
- The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Voluntarily sign the informed consent form (ICF); * 2.Male or female, ≥ 18 years and ≤ 70 years old; * 3.Survival duration more than 3 months; * 4.ECOG score ≤ 1 point; * 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; * 6.At least one measurable tumor lession according to RECIST v1.1; * 7.Adequate organ and bone marrow function. Exclusion Criteria: * 1.Has participated in another clinical study within 4 weeks prior to the first dose; * 2.Other malignancies diagnosed within 1 years prior to the enrollment; * 3\. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases; * 4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation; * 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding; * 6.Presence of pleural effusion, peritoneal effusion, or ascites; * 7.Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment * 8.History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs; * 9.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence; * 10.History of severe allergies, severe drug allergies (including unapproved investigational drugs); * 11.History of organ transplantation or stem cell transplantation; * 12.Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study; * 13.Pregnant or breastfeeding female.
References
Publications (0)
Data not yet available