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Advanced Solid TumorPhase 2NCT06446388

Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

A Phase 2 study testing QLS31905, Oxaliplatin and Capecitabine in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
QLS31905, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteChina
Study dates
30 Jun 2024to 1 Dec 2027
Phase
Phase 2
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 to 75 years
  • 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 be positive for Claudin18.2 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. Contact the study team or a site near you to ask about taking part.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, M.D, 010-881965671, linshenpku@163.com

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

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.

  • OxaliplatinDrug

    130 mg/m2, intravenous infusion, D1, up to 8 cycles.

  • CapecitabineDrug

    1000 mg/m2, oral, bid, D1-D14

  • GemcitabineDrug

    1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.

  • CisplatinDrug

    25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.

  • QL1706Drug

    5 mg/kg, intravenous infusion,D1

  • Chemotherapy drugDrug

    Standard chemotherapy recommended by guidelines.

Study groups in NCT06446388
Study groupRoleWhat they receive
QLS31905 + oxaliplatin + capecitabineExperimentalGastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
Receives: Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine
QL1706 + oxaliplatin + capecitabineExperimentalGastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: QL1706
QLS31905 + oxaliplatin + capecitabine + QL1706ExperimentalGastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
Receives: Drug: QLS31905; Drug: Oxaliplatin; Drug: Capecitabine; Drug: QL1706
QLS31905 + gemcitabine+cisplatinExperimentalBiliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
Receives: Drug: QLS31905; Drug: Gemcitabine; Drug: Cisplatin
QL1706 + gemcitabine+cisplatinExperimentalBiliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: QL1706
QLS31905 + gemcitabine+cisplatin+ QL1706ExperimentalBiliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
Receives: Drug: QLS31905; Drug: Gemcitabine; Drug: Cisplatin; Drug: QL1706
QLS31905 + standard chemotherapyExperimentalOther solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.
Receives: Drug: QLS31905; Drug: Chemotherapy drug
QL1706 + standard chemotherapyExperimentalOther solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.
Receives: Drug: QL1706; Drug: Chemotherapy drug
QLS31905 + standard chemotherapy + QL1706ExperimentalOther solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
Receives: Drug: QLS31905; Drug: QL1706; Drug: Chemotherapy drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)

    Measured: Approximately 24 months

Secondary outcomes (12)

  1. 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 24 months

  2. 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 24 months

  3. Number of participants with laboratory value abnormalities

    Number of participants with potentially clinically significant laboratory values.

    Measured: Approximately 24 months

  4. Duration of Response (DOR)

    DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first).

    Measured: Approximately 24 months

  5. 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 radiological progressive disease or death due to any cause (whichever occurs first).

    Measured: Approximately 24 months

  6. 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 24 months

  7. Maximum concentration (Cmax)

    Cmax will be derived from the PK serum samples collected.

    Measured: Approximately 24 months

  8. Time of the maximum concentration (Tmax)

    Tmax will be derived from the PK serum samples collected.

    Measured: Approximately 24 months

  9. Terminal elimination half-life (T1/2)

    T1/2 will be derived from the PK serum samples collected.

    Measured: Approximately 24 months

  10. Clearance (CL)

    CL will be derived from the PK serum samples collected.

    Measured: Approximately 24 months

  11. Apparent volume of distribution during the terminal phase (Vz)

    Vz will be derived from the PK serum samples collected.

    Measured: Approximately 24 months

  12. Number of anti-drug antibody (ADA) Positive Participants

    Immunogenicity will be measured by the number of participants that are ADA positive.

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start30 Jun 2024 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446388
Sponsor's protocol ID
QLS31905-202
Status last verified
May 2024
First submitted
1 Jun 2024
Last updated
6 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QLS31905, Oxaliplatin and Capecitabine in people with Advanced 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 5 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 6 Jun 2024. 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 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Approximately 24 months). 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 NCT06446388.

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 6 Jun 2024.

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