Solid TumorsPhase 1NCT07358884
First in Human Study of QLS5316 in Solid Tumors
A Phase 1 study testing QLS5316 in people with Solid Tumors and Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Colorectal Cancer, Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- QLS5316
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 3 months;
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
- Dose escalation and PK expansion stages: Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, who have failed SOC or SOC is not available
- Cohort expansion stage: Patients with histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, including CRC, GC/GEJ, HNSCC (mouth, oropharynx, hypopharynx or larynx), EGFR-sensitive mutant NSCLC and EGFR wild-type NSCLC or other advanced malignant solid tumors who have failed SOC or SOC is not available.
Who cannot join
- Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and/or c-MET targeted ADCs
- Untreated or active brain metastasis
- Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy
- Patients with a history of interstitial lung disease (ILD)/non-infectious pneumonia, or patients whose suspected ILD/non-infectious pneumonia cannot be ruled out by imaging examination at screening; patients with radiation pneumonitis who do not require steroid treatment are allowed to be enrolled;
- Patients with a history of active tuberculosis, active autoimmune diseases or autoimmune diseases that may recur
- Patients with a history of severe cardiovascular and cardiovascular diseases
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- Clinically uncontrollable third space effusion
- Presence of persistent uncontrolled systemic bacterial, fungal or viral infections or severe infections within 4 weeks before the first dose in the study, or active infections requiring systematic antibiotic treatment within 1 week before the first dose in the study;
- Known hypersensitivity reactions or delayed-type sensitization to some components or analogues of the investigational drug
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5316 Monotherapy in Patients With Advanced Solid Tumors
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy.
- Conditions
- Solid Tumors, Colorectal Cancer, Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer
- Being tested
- QLS5316
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5316Drug
Varying doses of QLS5316
| Study group | Role | What they receive |
|---|---|---|
| QLS5316 | Experimental | patients with advanced solid tumors were administrated with varying doses of QLS5316 specified in protocol Receives: Drug: QLS5316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
To evaluate the safety and tolerability of QLS5316
Measured: From time of Informed Consent to 30 days post last dose of QLS5316
Number of Participants With Clinical Laboratory Test Abnormalities
Clinical laboratory test included Hematology, Blood and serum chemistry, Coagulation function, and Fecal occult blood.
Measured: From time of Informed Consent to 30 days post last dose of QLS5316
12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval)
Assessment of abnormal electrocardiogram parameters before and after treatment
Measured: From time of Informed Consent to 30 days post last dose of QLS5316
Number of participants with physical examination abnormalities
Including general conditions, skin and mucosa, systemic superficial lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system, and other examinations.
Measured: From time of Informed Consent to 30 days post last dose of QLS5316
Number of participants with vital signs abnormalities
Including body temperature, respiratory rate, pulse, blood pressure, and oxygen saturation
Measured: From time of Informed Consent to 30 days post last dose of QLS5316
DLT
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Protocol
Measured: From time of first dose of QLS5316 to end of DLT period (21 days)
MTD
the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLS5316 monotherapy
Measured: 1 year
RP2D
the recommended phase II dose of QLS5316 monotherapy
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358884
- Sponsor's protocol ID
- QLS5316-101
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5316 Monotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07358884
- Acronym / sponsor ID
- QLS5316-101
- Conditions
- Solid Tumors, Colorectal Cancer, Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (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 a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS5316 | Experimental | Drug: QLS5316patients with advanced solid tumors were administrated with varying doses of QLS5316 specified in protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 3 months;
- Measurable disease per RECIST v1.1
- Adequate organ and marrow function as defined in the protocol
Key exclusion criteria (9 listed)
- Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and/or c-MET targeted ADCs
- Untreated or active brain metastasis
- Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy
- Patients with a history of interstitial lung disease (ILD)/non-infectious pneumonia, or patients whose suspected ILD/non-infectious pneumonia cannot be ruled out by imaging examination at screening; patients with radiation pneumonitis who do not require steroid treatment are allowed to be enrolled;
- Patients with a history of active tuberculosis, active autoimmune diseases or autoimmune diseases that may recur
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 |
|---|---|---|
| QLS5316Varying doses of QLS5316 | Drug | QLS5316 |
Primary outcome
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
Time frame: From time of Informed Consent to 30 days post last dose of QLS5316
To evaluate the safety and tolerability of QLS5316
Number of Participants With Clinical Laboratory Test Abnormalities
Time frame: From time of Informed Consent to 30 days post last dose of QLS5316
Clinical laboratory test included Hematology, Blood and serum chemistry, Coagulation function, and Fecal occult blood.
12-lead ECG(Including heart rate, QT interval, QTc interval, and P-R interval)
Time frame: From time of Informed Consent to 30 days post last dose of QLS5316
Assessment of abnormal electrocardiogram parameters before and after treatment
Number of participants with physical examination abnormalities
Time frame: From time of Informed Consent to 30 days post last dose of QLS5316
Including general conditions, skin and mucosa, systemic superficial lymph nodes, head and neck, chest, abdomen, spine and extremities, nervous system, and other examinations.
Number of participants with vital signs abnormalities
Time frame: From time of Informed Consent to 30 days post last dose of QLS5316
Including body temperature, respiratory rate, pulse, blood pressure, and oxygen saturation
DLT
Time frame: From time of first dose of QLS5316 to end of DLT period (21 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Protocol
MTD
Time frame: 1 year
the maximum tolerated dose (MTD) or maximum administered dose (MAD, if MTD fails to be determined) of QLS5316 monotherapy
RP2D
Time frame: 2 year
the recommended phase II dose of QLS5316 monotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS5316 in people with Solid Tumors and Colorectal Cancer, run by Qilu Pharmaceutical Co., Ltd..
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengxiang Ren, MD (021-65115006-3051, harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by NCI-CTCAE v5.0 (time frame: From time of Informed Consent to 30 days post last dose of QLS5316). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.