Clinical trial · Interventional
Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
A Phase I/IIa, Open-label, Dose-Escalation and Dose Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese 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
Summary
Brief summary (as posted)
This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 \~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).
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 Tumord | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TJ107 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TJ107
- description
- Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
- interventionNames
- Drug: TJ107
Primary outcomes (3)
- measure
- Dose Limiting Toxicities
- timeFrame
- 28days after first dose
- description
- Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)
- measure
- Adverse events
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Safety and tolerability of TJ107. Incidence of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged at least 18 years old; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~2; * Patients must have histological or cytological confirmation of advanced solid tumors that is refractory to standard therapy or for which there is no standard available therapy; * Predicted life expectancy ≥3 months; * Patients must have adequate organ and marrow function; * Patients at reproductive age should take adequate contraceptive measures while on study drug and for 6 months following the last dose of study drug. * Patients should have the ability and willingness to comply with the study and follow up. And patients must be able to provide written informed consent. Exclusion Criteria: * Patients who have experienced a Grade 3 or higher toxicity related to prior immunotherapy. * Patients who are still receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or other clinical trials from 4 weeks prior to the first dose, or patients who have not recovered from previous toxicity to level 1. * Women who are pregnant or breast feeding * Patients who are drug-dependent or have a history of substance abuse or psychonosema history. * Have been vaccinated within 4 weeks of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine during study * Prior allogeneic bone marrow transplantation or prior solid organ transplantation * Positive laboratory test for HBsAg with HBV DNA ≥ 100 IU/mL, or positive laboratory test for HCV. * Prior treatment with immune checkpoint inhibitors, immunomodulatory mAbs, and/or mAb-derived therapies is allowed provided that at least 3 months or 5 half-lives of the drug, whichever is longer, have elapsed from the last dose. * Uncontrolled concurrent illness. * Major surgery procedure (excluding diagnostic surgery) within 4 weeks of the first dose of study drug. * Patients with a history of treated CNS metastases. * Other psychiatric illness/social situations that would limit compliance with the study requirements decided by the investigator.
References
Publications (0)
Data not yet available