QLS5212 for Participants With Advanced Solid Tumors

NCT07467629 | Recruiting Phase 1

• 1 other identifier: QLS5212-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.

Conditions

Solid Tumor Cancer

Outcome Measures

Primary Outcomes (4)

• Maximum tolerated dose (MTD)

  From First Patient Dosed to end of Escalation (up to 14 months).

• Dose-limiting Toxicity (DLT)

  From enrollment to 21 days of treatment.

• Recommended Phase 2 dose (RP2D)

  From First Patient Dosed to end of Escalation (up to 14 months).

• Incidence of Treatment-Emergent Adverse Events

  From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later).

Secondary Outcomes (3)

• Maximum Plasma Concentration of QLS5212

  From Day 1 of dosing through 7 days after last dose.

• Area Under the Curve (AUC) of QLS5212

  From Day 1 of dosing to 7 days after last dose.

• Circulating anti-drug antibodies (ADA) of QLS5212

  From Day 1 of dosing to 7 days after last dose.

Study Arms (1)

QLS5212 Dose Escalation

EXPERIMENTAL

Drug: QLS5212

Interventions

QLS5212 DRUG

An anti-trophoblast glycoprotein antibody-drug conjugate

QLS5212 Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
• Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
• Age ≥ 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
• Life expectancy ≥ 3 months.
• Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and/or MRI.
• \. Acceptable laboratory parameters:
• Absolute neutrophil count ≥ 1,500/μL.
• Platelet count ≥ 100 × 1000/μL
• Hemoglobin ≥ 9.0 g/dL.
• Albumin ≥ 3 g/dL.
• ALT/AST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）
• Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.
• a calculated or measured creatinine clearance ≥60 mL/minute.

You may not qualify if:

• History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;
• Untreated or active brain metastases, including leptomeningeal carcinomatosis;
• Prior systemic anti-cancer therapy within specified windows;
• Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;
• Clinically significant cardiovascular disease;
• Uncontrolled systemic infection or active tuberculosis;
• Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;
• Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanxi Provincial Cancer Hospital (China Medical Sciences Academy Cancer Hospital Shanxi Hospital)

Taiyuan, China

RECRUITING

Central Study Contacts

Jie Wang, Doctor

CONTACT

0351-4881611; zlhuxi@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: March 8, 2026
• First Posted: March 12, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): November 5, 2027
• Study Completion (Estimated): April 5, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (1)