A Study of QLM2011 in Subjects With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of QLM2011 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: QLM2011; Drug: Taxotere®

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLM2011	Drug: QLM2011; QLM2011l by intravenous infusion.
Experimental: Taxotere®	Drug: Taxotere®; Taxotere® by intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	The DLT of QLM2011 will be determined.	21 days
Maximum tolerated dose (MTD)	The maximum tolerated dose (MTD) (if available) of QLM2011.	up to 1 years
recommended Phase 2 dose (RP2D)	recommended Phase 2 dose (RP2D) of QLM2011.	up to 1 years

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: QLM2011-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No