CLDN18.2-positive Advanced Biliary Tract CancerPhase 2NCT07151872
Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
A Phase 2 study testing QLS31905 for Injection, Gemcitabine Hydrochloride for Injection and Cisplatin for Injection in people with CLDN18.2-positive Advanced Biliary Tract Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CLDN18.2-positive Advanced Biliary Tract Cancer
- What is being tested?
- QLS31905 for Injection, Gemcitabine Hydrochloride for Injection and Cisplatin for Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2026
- 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 with unresectable locally advanced or metastatic Biliary Tract Cancer 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 Biliary Tract Cancer.
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 Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, 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.
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer
- Being tested
- QLS31905 for Injection, Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, QL2107 Injection, Oxaliplatin Injection
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
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine Hydrochloride for Injection
Cisplatin for InjectionDrug
Cisplatin for Injection
QL2107 InjectionDrug
QL2107 Injection
Oxaliplatin InjectionDrug
Oxaliplatin Injection
Capecitabine TabletsDrug
Capecitabine Tablets
| Study group | Role | What they receive |
|---|---|---|
| QLS31905 +GP | Experimental | Not described Receives: Drug: QLS31905 for Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for Injection |
| QLS31905 +GP+QL2107 | Experimental | Not described Receives: Drug: QLS31905 for Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for Injection; Drug: QL2107 Injection |
| QLS31905 +XELOX | Experimental | Not described Receives: Drug: QLS31905 for Injection; Drug: Oxaliplatin Injection; Drug: Capecitabine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLDN18.2-positive Advanced Biliary Tract CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT07151872
- Sponsor's protocol ID
- QLS31905-205
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07151872
- Acronym / sponsor ID
- QLS31905-205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Sep 2025 (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 II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QLS31905 +GP | Experimental | Drug: QLS31905 for Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Cisplatin for Injection |
| QLS31905 +GP+QL2107 | Experimental | Drug: QLS31905 for Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Cisplatin for Injection, Drug: QL2107 Injection |
| QLS31905 +XELOX | Experimental | Drug: QLS31905 for Injection, Drug: Oxaliplatin Injection, Drug: Capecitabine Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer 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 Biliary Tract Cancer.
Key exclusion criteria (3 listed)
- 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 Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, 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;
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 |
|---|---|---|
| QLS31905 for InjectionQLS31905 for Injection | Drug | QLS31905 +GP, QLS31905 +GP+QL2107, QLS31905 +XELOX |
| Gemcitabine Hydrochloride for InjectionGemcitabine Hydrochloride for Injection | Drug | QLS31905 +GP, QLS31905 +GP+QL2107 |
| Cisplatin for InjectionCisplatin for Injection | Drug | QLS31905 +GP, QLS31905 +GP+QL2107 |
| QL2107 InjectionQL2107 Injection | Drug | QLS31905 +GP+QL2107 |
| Oxaliplatin InjectionOxaliplatin Injection | Drug | QLS31905 +XELOX |
| Capecitabine TabletsCapecitabine Tablets | Drug | QLS31905 +XELOX |
Primary outcome
ORR (Objective Response Rate)
Time frame: Approximately 24 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 per RECIST 1.1
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 3 Sep 2025.
Related trials for CLDN18.2-positive Advanced Biliary Tract Cancer
Active, not recruitingPhase 1/2
Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody
Biliary Tract Cancer, Candonilimab
RecruitingPhase 2
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
Biliary Tract Cancer
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 2 study testing QLS31905 for Injection, Gemcitabine Hydrochloride for Injection and Cisplatin for Injection in people with CLDN18.2-positive Advanced Biliary Tract 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 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 3 Sep 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 Tongsen Zheng, PHD (15134569619, zhengtongsen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (Objective Response Rate) (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?
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 3 Sep 2025.