Clinical trial · Interventional
A Study of QL1706H in Patients With Advanced Solid Tumors
A Phase Ⅰ Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of QL1706H in Advanced Solid Tumors
NCT06047431CI-TRIAL-00069805unknownPhase 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 is an open-label, Phase Ⅰ study of QL1706H in patients with advanced solid tumors. The study will evaluate the pharmacokenetics, safety, tolerability and preliminary efficacy of QL1706H.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1706H | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QL1706H
- description
- Part 1 (Dose escalation): QL1706H will be administered in sequential cohorts each receiving 1 dose of QL1706H by subcutaneous injection on day 1 and QL1706 by IV infusion on day 22, from then on will recieve QL1706 on day 1 of every 21-day cycle (3 weeks). Dose escalation will continue until the projected cohorts has been finished. Part 2 (Dose Exploration): The PK parameters of QL1706H will be tested at different administration intervals.
- interventionNames
- Drug: QL1706H
Primary outcomes (1)
- measure
- Minimum Serum Drug Concentration ( Ctrough)
- timeFrame
- one cycle (3 weeks)
- description
- The minimum serum drug concentration and area under serum concentration-time curve after single administration of QL1706H.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects participate voluntarily and sign informed consent. * Patients with Pathologically confirmed metastatic or recurrent malignant solid tumors, failure or intolerance of at least first-line treatment and unsuitable for radical treatment such as surgery * Subject has at least one measurable lesion according to RECIST (V1.1) evaluation criteria. * Eastern Cooperative Oncology Group (ECOG) score was 0 or 1. * The extension of life is more than 3 months * Vital organs' function is adequate for enrolling * Subjects agree to use effective contraceptive measures.Women who have not been pregnant or breastfeeding. * Before the first use of the investigational drug, all the reversible toxicity of the previous antitumor therapy returned to ≤1 (according to CTCAE V5.0),Excluding any grade of hair loss and pigmentation, grade 2 or less peripheral sensory neuropathy, and other abnormalities that the investigator and/or sponsor assessed to outweigh the risk of toxicity. Exclusion Criteria: * Active autoimmune diseases that exist within 2 years prior to the first use of the investigational drug and require systemic treatment. * There are known past grade 3 or 4 immune-related adverse events associated with antitumor immunotherapy. * Symptomatic central nervous system (CNS) metastasis, pia metastasis or spinal cord compression due to metastasis prior to signing informed consent. * Subjects with any of the following cardiovascular diseases that seriously endanger the safety of the subjects or affect the completion of the study * Subjects with diseases that are planned to be treated with systemic corticosteroids or other immunosuppressive drugs during the study period * Prior treatment with cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitor combined with programmed cell death protein-1 (PD-1) inhibitor, or CTLA-4 inhibitor combined with PD-L1 inhibitor. * Had received chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of experimental drugs * Subjects with positive antibodies to HIV;Treponema pallidum antibody positive;HBsAg positive patients with VIRAL DEoxy ribonucleic acid (HBV DNA) \>2000 IU/ mL or 10\^4 copy number/mL should receive antiviral therapy according to local treatment guidelines and be willing to receive antiviral therapy throughout the study period.Hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive
References
Publications (0)
Data not yet available
No reference posted for this study.