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Gastric AdenocarcinomaPhase 2NCT06942767

Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

A Phase 2 study testing QLS31905 for Injection, QL2107 Injection and Oxaliplatin Injection in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Qilu Pharmaceutical Co., Ltd..

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
Search all trials

Trial summary

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
QLS31905 for Injection, QL2107 Injection and Oxaliplatin Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Jun 2025to Mar 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological or cytological examination;
  • Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
  • No prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Who cannot join

  • Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
  • Subjects had other second primary malignancies within 5 years prior to the first dose;
  • Subjects with clinically significant hemorrhage within 3 months before the first dose

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lin Shen, PHD contact

010-881965671

linshenpku@163.com

About this study

Official title: An Open-label, Multicenter Phase II Clinical Study of QLS31905 for Injection Combined With QL2107 Injection and XELOX Regimen in the First-line Treatment of CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Read the detailed description

QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.

QL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Being tested
QLS31905 for Injection, QL2107 Injection, Oxaliplatin Injection, Capecitabine Tablets
Keywords
CLDN18.2, gastric or gastroesophageal junction (GEJ) adenocarcinoma
Medical subject headings
Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QLS31905 for InjectionDrug

    QLS31905 for Injection

  • QL2107 InjectionDrug

    QL2107 Injection

  • Oxaliplatin InjectionDrug

    Oxaliplatin Injection

  • Capecitabine TabletsDrug

    Capecitabine Tablets

Study groups in NCT06942767
Study groupRoleWhat they receive
QLS31905+QL2107+ XELOXExperimentalQLS31905+QL2107+ oxaliplatin + capecitabine
Receives: Drug: QLS31905 for Injection; Drug: QL2107 Injection; Drug: Oxaliplatin Injection; Drug: Capecitabine Tablets

What is being measured

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

  1. DLT

    Dose Limiting Toxicity，for Dose Escalation Stage

    Measured: up to 42 days following first dose

  2. MTD

    Maximum Tolerated Dose，for Dose Escalation Stage.

    Measured: up to 42 days following first dose

  3. ORR (Objective Response Rate)

    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 per RECIST 1.1

    Measured: Approximately 24 months

Secondary outcomes (7)

  1. AE (adverse events)

    AEs are any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Approximately 24 months

  2. 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

  3. DOR (Duration of Response)

    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

  4. PFS (Progression Free Survival)

    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

  5. OS (Overall Survival)

    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

  6. Maximum concentration (Cmax)

    Cmax will be derived from the PK serum samples collected.

    Measured: Approximately 24 months

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

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

    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 posted24 Apr 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942767
Sponsor's protocol ID
QLS31905-203
Status last verified
Apr 2025
First submitted
17 Apr 2025
Last updated
27 Apr 2025
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 for Injection, QL2107 Injection and Oxaliplatin Injection in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, 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 3 inclusion and 3 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 27 Apr 2025. 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 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?

Contact Lin Shen, PHD (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?

DLT (time frame: up to 42 days following first dose). 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?

On the ClinicalTrials.gov record for NCT06942767.

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 27 Apr 2025.

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