Solid TumorPhase 1/2NCT06041035
A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors
A Phase 1/2 study testing QLS31905, Nab paclitaxel and Gemcitabine in people with Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- QLS31905, Nab paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- Oct 2023to Oct 2025
- Phase
- Phase 1/2
- 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
- Subjects voluntarily participate in the study and sign the informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival time ≥ 3 months;
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
- No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
- Tumor tissue samples determined to have moderate-to-high Claudin18.2 expression by immunohistochemistry (IHC);
- At least one measurable lesion per RECIST v1.1;
- Patients with adequate cardiac, liver, renal function, etc.
Who cannot join
- History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- Known central nervous system metastases;
- Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
- Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
- Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors
This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- QLS31905, Nab paclitaxel, Gemcitabine, Oxaliplatin, Capecitabine
- Keywords
- CLDN18.2, QLS31905
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS31905Drug
Administered as an intravenous infusion.
Nab paclitaxelDrug
125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
GemcitabineDrug
1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
OxaliplatinDrug
85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
CapecitabineDrug
1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
CisplatinDrug
25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) | Experimental | Pancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine. Receives: Drug: QLS31905; Drug: Nab paclitaxel; Drug: Gemcitabine |
| QLS31905 + oxaliplatin + capecitabine (Part B) | Experimental | In part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine. Receives: Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine |
| QLS31905 + gemcitabine+cisplatin(Part B) | Experimental | In part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer. Receives: Drug: QLS31905; Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) (Part A)
As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.
Measured: Approximately 12 months
Phase 2 Recommended Dose（RP2D)(Part A)
Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.
Measured: Approximately 12 months
Objective response rate (ORR)(Part B)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Measured: Approximately 12 months
Secondary outcomes (12)
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: Approximately 12 months
Safety assessed by incidence of serious adverse events (SAE)
Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.
Measured: Approximately 12 months
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
Measured: Approximately 12 months
Progression Free Survival(PFS)
PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Measured: Approximately 12 months
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
Measured: Approximately 12 months
Overall Survival (OS)
OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.
Measured: Approximately 12 months
Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax)
Cmax will be derived from the PK serum samples collected.
Measured: Approximately 12 months
PK of QLS31905: Time of the maximum concentration (Tmax)
Tmax will be derived from the PK serum samples collected.
Measured: Approximately 12 months
PK of QLS31905: Terminal elimination half-life (T1/2)
T1/2 will be derived from the PK serum samples collected.
Measured: Approximately 12 months
PK of QLS31905: Clearance (CL)
CL will be derived from the PK serum samples collected.
Measured: Approximately 12 months
PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz)
Vz will be derived from the PK serum samples collected.
Measured: Approximately 12 months
Number of anti-drug antibody (ADA) Positive Participants
Immunogenicity will be measured by the number of participants that are ADA positive.
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 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
- NCT06041035
- Sponsor's protocol ID
- QLS31905-201
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06041035
- Acronym / sponsor ID
- QLS31905-201
- Conditions
- Solid Tumor
- Keywords
- CLDN18.2, QLS31905
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Sep 2023 (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 study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) | Experimental | Drug: QLS31905, Drug: Nab paclitaxel, Drug: GemcitabinePancreatic cancer participants will be treated with QLS31905 in combination with nab-paclitaxel and gemcitabine for part A of the study to establish the recommended dose of QLS31905 for part B. In part B, the participants will be treated with QLS31905 at a dose determined by the part A of the study in combination with nab-paclitaxel and gemcitabine. |
| QLS31905 + oxaliplatin + capecitabine (Part B) | Experimental | Drug: QLS31905, Drug: Oxaliplatin, Drug: CapecitabineIn part B, gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at dose determined by part A of the study in combination with oxaliplatin and capecitabine. |
| QLS31905 + gemcitabine+cisplatin(Part B) | Experimental | Drug: QLS31905, Drug: Gemcitabine, Drug: CisplatinIn part B, other solid tumor participants including but not limited to biliary tract cancer will be treated with QLS31905 at dose determined by part A in combination with standard chemotherapy recommended by guidelines.QLS31905 plus gemcitabine+ cisplatin as the first-line treatment of advanced biliary tract cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in the study and sign the informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival time ≥ 3 months;
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
- No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
Key exclusion criteria (6 listed)
- History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- Known central nervous system metastases;
- Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
- Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
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 |
|---|---|---|
| QLS31905Administered as an intravenous infusion. | Drug | QLS31905 + gemcitabine+cisplatin(Part B), QLS31905 + nab-paclitaxel + gemcitabine (Part A/B), QLS31905 + oxaliplatin + capecitabine (Part B) |
| Nab paclitaxel125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle. | Drug | QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) |
| Gemcitabine1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle. | Drug | QLS31905 + gemcitabine+cisplatin(Part B), QLS31905 + nab-paclitaxel + gemcitabine (Part A/B) |
| Oxaliplatin85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles. | Drug | QLS31905 + oxaliplatin + capecitabine (Part B) |
| Capecitabine1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles. | Drug | QLS31905 + oxaliplatin + capecitabine (Part B) |
| Cisplatin25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles. | Drug | QLS31905 + gemcitabine+cisplatin(Part B) |
Primary outcome
Maximum Tolerated Dose (MTD) (Part A)
Time frame: Approximately 12 months
As measured by number of participants experiencing dose related toxicity (DLT) in each escalating cohort.
Phase 2 Recommended Dose（RP2D)(Part A)
Time frame: Approximately 12 months
Monitor for MTD, and minimal efficacious dose by monitoring responses at different dose levels.
Objective response rate (ORR)(Part B)
Time frame: Approximately 12 months
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
12 secondary outcomes
Safety assessed by Adverse Events (AEs)
Time frame: Approximately 12 months
Safety assessed by incidence of serious adverse events (SAE)
Time frame: Approximately 12 months
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: Approximately 12 months
Progression Free Survival(PFS)
Time frame: Approximately 12 months
Duration Of Response (DOR)
Time frame: Approximately 12 months
Overall Survival (OS)
Time frame: Approximately 12 months
Pharmacokinetics(PK) of QLS31905: Maximum concentration (Cmax)
Time frame: Approximately 12 months
PK of QLS31905: Time of the maximum concentration (Tmax)
Time frame: Approximately 12 months
PK of QLS31905: Terminal elimination half-life (T1/2)
Time frame: Approximately 12 months
PK of QLS31905: Clearance (CL)
Time frame: Approximately 12 months
PK of QLS31905: Apparent volume of distribution during the terminal phase (Vz)
Time frame: Approximately 12 months
Number of anti-drug antibody (ADA) Positive Participants
Time frame: Approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QLS31905, Nab paclitaxel and Gemcitabine in people with Solid 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 8 inclusion and 6 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 18 Sep 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lin Shen, M.D (010-881965671, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (Part A) (time frame: Approximately 12 months). The study lists 3 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 18 Sep 2023.