Advanced Malignant TumorPhase 1NCT04296994
A Study of QL1706 in Subjects With Advanced Malignant Tumor
A Phase 1 study testing QL1706 in people with Advanced Malignant Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumor
- What is being tested?
- QL1706
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2020to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of ≥3 months.
- The functional level of important organs must meet the requirements before the first dose of study drug.
- 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.
- Patients with pathological diagnosis of advanced/metastatic malignant tumor have progressed disease on standard therapy or for which no effective therapy is avalizble.
Who cannot join
- 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.
- Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.
- Known symptomatic brain metastases, leptomeningeal disease or spinal cord compression.
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment on decision of investigator. .
- 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.
- 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.
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- Major surgery within 28 days before the first dose of study drug and not recovered fully from any complications from surgery.
- Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
- Subjects with the history of organ transplant or allogeneic hematopoietic stem cells transpalnt.
- Positive for Human immunodeficiency virus（HIV）or Hepatitis B ,active Hepatitis C.
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The study was divided into screening/baseline, treatment and follow-up periods. Safety monitoring will be conducted throughout the study period. DLT will be determined 21 days (1 cycle) after the first administration of QL1706 based on the occurrence of AE during the treatment period.
- Conditions
- Advanced Malignant Tumor
- Being tested
- QL1706
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Biological
Also called PSB205
QL1706（PSB205） is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Open-label Dose Escalation and Expansion Study of QL1706 | Experimental | 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. Receives: Biological: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
Measured: 1 Cycles (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start31 Mar 2020
- Primary completion31 Dec 2021
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced Malignant TumorStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Doctor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296994
- Sponsor's protocol ID
- QL1706-101
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2020
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma Y, Lin S, Chen Q, Xue J, Yang Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Li W, Li Q, Zhu C, Huang Z, Kang X, Xue S, Li H, Wang C, Luo F, Huang Y, Zhang L, Zhao H. Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study. Cell Rep Med. 2025 Oct 21;6(10):102396. doi: 10.1016/j.xcrm.2025.102396. Epub 2025 Oct 3.
PubMed 41045933Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.
PubMed 37158938
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04296994
- Acronym / sponsor ID
- QL1706-101
- Conditions
- Advanced Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was divided into screening/baseline, treatment and follow-up periods. Safety monitoring will be conducted throughout the study period. DLT will be determined 21 days (1 cycle) after the first administration of QL1706 based on the occurrence of AE during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label Dose Escalation and Expansion Study of QL1706 | Experimental | Biological: QL1706Part 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy of ≥3 months.
- The functional level of important organs must meet the requirements before the first dose of study drug.
- 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.
Key exclusion criteria (11 listed)
- 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.
- Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.
- Known symptomatic brain metastases, leptomeningeal disease or spinal cord compression.
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment on decision of investigator. .
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1706Also: PSB205QL1706（PSB205） is a bi-functional product that has been engineered to contain two unique monoclonal antibodies. | Biological | Open-label Dose Escalation and Expansion Study of QL1706 |
Primary outcome
Safety and tolerability
Time frame: 1 Cycles (21 days)
Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 41045933Ma Y, Lin S, Chen Q, Xue J, Yang Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Li W, Li Q, Zhu C, Huang Z, Kang X, Xue S, Li H, Wang C, Luo F, Huang Y, Zhang L, Zhao H. Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study. Cell Rep Med. 2025 Oct 21;6(10):102396. doi: 10.1016/j.xcrm.2025.102396. Epub 2025 Oct 3.
- Derived from this study: PubMed 37158938Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, Doctor principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL1706 in people with Advanced Malignant Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 1 Cycles (21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04296994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.