A Study of QL1706 in Subjects With Advanced Malignant Tumor

• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04296994
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 10.1
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

This is an open-label, multicenter, Phase 1, ascending dose escalation study of QL1706 in subjects with advanced malignant tumor. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of QL1706. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of QL1706 in subjects with advanced malignant tumor. Part 2 of the study will further characterize the PK parameters for QL1706 in subjects with advanced malignant tumor.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignant Tumor	Biological: QL1706	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of QL1706 in Patients With Advanced Malignant Tumor
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Jan 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Open-label Dose Escalation and Expansion Study of QL1706 Part 1 (Dose escalation): QL1706 will be administered in sequential cohorts each receiving 1 of 4 doses of QL1706 on day 1 of every 21-day cycle (3 weeks) via IV infusion. Dose escalation will continue until an MTD is reached. Part 2 (Dose Expansion): The PK parameters of QL1706 will be tested at 2-3 doses determined during the dose-escalation phase in subjects with advanced malignant tumor cohorts.

Biological: QL1706; QL1706（PSB205） is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.; Other Names: PSB205

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [1 Cycles (21 days)]

   Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female subjects aged 18 years or older.

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

3. Life expectancy of ≥3 months.

4. The functional level of important organs must meet the requirements before the first dose of study drug.

5. Male and female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose.Female subjects who are not pregnant or breastfeeding.

6. Patients with pathological diagnosis of advanced/metastatic malignant tumor have progressed disease on standard therapy or for which no effective therapy is avalizble.

Exclusion Criteria:

1. Active or prior documented autoimmune disease. Subjects who have stable hypothyroidism with hormone replacement ,childhood atopy or asthma, vitiligo, alopecia, , or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.

2. Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.

3. Known symptomatic brain metastases, leptomeningeal disease or spinal cord compression.

4. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment on decision of investigator. .

5. Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.

6. Systemic anti-cancer treatment. This includes radiotherapy ,small molecule targeted therapy<2 weeks before the first dose of study drug, ≤4 weeks for chemotherapy，monoclonal antibody;≤8 weeks for cell-based therapy or anti-tumor vaccine.

7. Major surgery within 28 days before the first dose of study drug and not recovered fully from any complications from surgery.

8. Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.

9. Subjects with the history of organ transplant or allogeneic hematopoietic stem cells transpalnt.

10. Positive for Human immunodeficiency virus（HIV）or Hepatitis B ,active Hepatitis C.

11. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen Univeisity Cancer Center	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04296994
• Other Study ID Numbers: QL1706-101
• First Posted: Mar 5, 2020
• Last Update Posted: Mar 5, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 5, 2020