Clinical trial NCT06925659: A Study of QLM2011 in Subjects With Advanced Solid Tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of QLM2011 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 21 days
measure: Maximum tolerated dose (MTD)
timeFrame: up to 1 years
measure: recommended Phase 2 dose (RP2D)
timeFrame: up to 1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: