A Study of QLF3108 in Participants With Advanced Solid Tumor

NCT06019013 | Unknown Phase 1

• 1 other identifier: QLF3108-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in patients with advanced solid tumor.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• DLTs of QLF3108

  dose-limiting toxicity

  Approximately 24 months

• MTD(s) of QLF3108

  the maximum tolerated dose

  Approximately 24 months

• RP2D of QLF3108

  a recommended Phase 2 dose

  Approximately 24 months

Secondary Outcomes (10)

• The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0

  Approximately 24 month

• The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0

  Approximately 24 month

• Cmax of QLF3108

  Approximately 24 month

• Tmax of QLF3108

  Approximately 24 month

• Area under the plasma concentration-time curve (AUC) of QLF3108

  Approximately 24 month

Study Arms (1)

Dose-Escalation Stage and PK-Expansion Stage

EXPERIMENTAL

Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD). PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial.

Drug: QLF3108

Interventions

QLF3108 DRUG

QLF3108 will be administered independent of body weight.

Dose-Escalation Stage and PK-Expansion Stage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial.
• ≥18 years old and body weight ≥40 kg; Female or male.
• Histologically or cytologically documented advanced solid tumor;
• Failed to standard therapy or intolerance, or lack standard therapy advanced solid tumors.
• Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.
• Life expectancy of at least 12 weeks.
• Adequate hematologic and end organ function.
• Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy test for females of childbearing potential within 7 days prior to first dosing.
• Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study.

You may not qualify if:

• Patients that have previously received cancer therapy within 4 weeks prior to the first dose of the investigational drug.
• Patient has received other investigational drug or other clinical trial treatment within 4 weeks prior to the first dose of the investigational drug.
• Active autoimmune disease that has required systemic treatment within 2 years prior to this study.
• A live vaccine or live attenuated vaccine was administered within 30 days prior to the first dose of the investigational drug.
• Patients with Adverse Events(AEs) from previous treatment that have not recovered to ≤1(CTCAE 5.0）; or are unstable status.
• Severe concomitant medical condition for bowel obstruction, or implanted colon stent during screening period.
• Patients with a history of HIV positive or other immunodeficiency. Or patients with the history of organ transplant or allogeneic bone marrow (excluding corneal transplantation).
• Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or alcohol abuse, may impact patient completion of the study.
• Patients may interfere with the interpretation of study results as determined by the investigator, or are unable to participate in the whole study, or deemed unsuitable by the investigator.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Study Officials

• Xu Jianming, M.D

  Chinese People's Liberation Army (PLA) General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Jianming, M.D

CONTACT

13910866712; Jianmingxu2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 31, 2023
• Study Start: August 16, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CN (1)