Advanced Solid Tumors
Conditions
Brief summary
This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The purposeaim of this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of QLM2011 in patients with advanced solid tumors.
Interventions
DRUGQLM2011
QLM2011l by intravenous infusion.
DRUGTaxotere®
Taxotere® by intravenous infusion
Sponsors
Qilu Pharmaceutical (Hainan) Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18, ≤80 years, no gender limitation； * Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable for the patient； * At least one measurable lesion as per RECIST version 1.1； * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1； * Life expectancy ≥3 months； * All subjects of reproductive potential must agree to use an effective method of contraception during the study and for 3 months after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose.
Exclusion criteria
* Chemotherapy, radiotherapy, targeted therapy， endocrine therapy, immunotherapy and other anti-tumor treatment within 28 days of the first dose of the study drug, 6 weeks for nitrosoureas or mitomycin C, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications. * Uncontrolled or clinically symptomatic serous cavity effusions (e.g., pericardial effusion, pleural effusion, ascites, etc.) requiring repeated puncture drainage or medical intervention. * Toxicity from prior antitumor therapy has not recovered to ≤ Grade 1 per the Common Terminology Criteria for Adverse Events (CTCAE v5.0) (exceptions include alopecia, peripheral neuropathy, isolated laboratory abnormalities, or other toxicities deemed by the investigator to pose no safety risk). * Have a history of other malignant tumors within 3 years before signing the informed consent, excluding cervical carcinoma in situ, basal cell carcinoma of the skin, papillary thyroid carcinoma or squamous cell carcinoma of the skin that has received radical treatment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | 21 days | The DLT of QLM2011 will be determined. |
| Maximum tolerated dose (MTD) | up to 1 years | The maximum tolerated dose (MTD) (if available) of QLM2011. |
| recommended Phase 2 dose (RP2D) | up to 1 years | recommended Phase 2 dose (RP2D) of QLM2011. |
Outcome results
None listed