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Advanced Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2/3NCT04435652

A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.

A Phase 2/3 study testing QL1604, Nab-paclitaxel and Paclitaxel in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
QL1604, Nab-paclitaxel and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
492 participants
Where
1 siteChina
Study dates
1 Jul 2020to 30 Nov 2022
Phase
Phase 2/3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
  • Age ≥ 18 years and ≤ 80 years when ICF is signed;
  • Have histologically or cytologically confirmed diagnosis of locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma(G/GEJC).
  • Eastern Cooperative Oncology Group performance status of 0 or 1;
  • Life expectancy of at least 12 weeks;
  • Have measurable disease as defined by RECIST 1.1 as determined by the investigator;
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  • Be willing to provide newly-obtained or paraffin-embedded tissue for PD-L1 and other biomarker analysis;
  • HER-2/neu negative；
  • Female subjects of childbearing potential should have a negative serum human chorionic gonadotropin(HCG) test within 7 days prior to receiving the first dose of study medication and are not breastfeeding;
  • Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose.

Who cannot join

  • Has non-G/GEJC such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated gastric cancer;
  • Known allergy or hypersensitivity to QL1604/nab-paclitaxel/paclitaxel or any components used in the preparation;
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease disease-relieving drugs, corticosteroids or immunosuppressant）;
  • Has a diagnosis of immunodeficiency or received systemic steroid therapy （>10mg daily of prednisone or equivalent drug）or any other form of immunosuppressive therapy within 14 days prior to the planned start of study therapy；
  • Subjects who have received radiotherapy, chemotherapy, monoclonal antibodies,targeted therapy, other anti-tumor treatments,or participating in other clinical studies is less than 4 weeks before the first dose of trial treatment;
  • Has a known additional malignancy that is progressing or requires active treatment in past 3 years;
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  • Subjects with known central nervous system (CNS) metastasis;
  • Has a history of pneumonitis that required steroids in past 3 years;
  • Has an active infection requiring systemic therapy；
  • Subjects with the history of Human Immunodeficiency Virus (HIV)、acquired, congenital immunodeficiency diseases、organ transplant;
  • Has hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive and HBV deoxyribonucleic acid (HBV DNA) >1000 copies/mL, or hepatitis C virus antibody positive;
  • Has received a live vaccine within 30 days of the planned start of study therapy；
  • Has received prior immune checkpoint inhibitors;
  • Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
  • Subjects with uncontrollable cardiac diseases;
  • Has accompanying diseases that seriously endanger the subject's safety or affect the study by the investigator;
  • Has any condition that increases the risk, interferes with the study results by the investigator, or investigators/sponsor consider the subjects are not suitable for this trial;

Trial locations and contacts

1 site in 1 country.

Shunjiang Yu, CMO contact

0531-83129659

shunjiang.yu@qilu-pharma.com

Weijian Guo, Professor contact

021-64175590

China1 site

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 2000 32

Other trials in China

About this study

Official title: A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel for Participants With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.

Being tested
QL1604, Nab-paclitaxel, Paclitaxel

What participants receive

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

  • QL1604Drug

    3mg/kg, D1,8,15,Q4w, IV infusion

  • Nab-paclitaxelDrug

    100mg/m2, D1,8,15,Q4w, IV infusion

  • PaclitaxelDrug

    80mg/m2, D1,8,15,Q4w, IV infusion

Study groups in NCT04435652
Study groupRoleWhat they receive
Experimental: Cohort AExperimentalParticipants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.
Receives: Drug: QL1604; Drug: Nab-paclitaxel
Experimental: Cohort B-arm1ExperimentalParticipants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years.
Receives: Drug: QL1604; Drug: Nab-paclitaxel
Experimental: Cohort B-arm2ExperimentalParticipants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
Receives: Drug: Paclitaxel

What is being measured

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

  1. The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0

    Safety and tolerability (stage 1)

    Measured: Up to 90 days from last dose

  2. The percentages of participants discontinuing or suspending the study drug due to an AE.

    Safety and tolerability (stage 1)

    Measured: Up to 90 days from last dose

  3. Overall survival（OS）（stage 2）

    Overall survival is defined as time from randomization to death due to any cause.

    Measured: from the date of first dose until the date of death from any cause,assessed up to 2 years

Secondary outcomes (10)

  1. Objective response rate（ORR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）

    Objective response rate（ORR）assessed by the investigators according to RECIST 1.1.

    Measured: up to 2 years

  2. Disease control rate（DCR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）

    Disease control rate（DCR）assessed by the investigators according to RECIST 1.1.

    Measured: up to 2 years

  3. Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1（stage 1 and 2）

    Progression-free survival（PFS）assessed by the investigators according to RECIST 1.1.

    Measured: up to 2 years

  4. Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1（stage 1 and 2）

    Tumor response rate（TRR）assessed by the investigators according to RECIST 1.1.

    Measured: up to 2 years

  5. Overall survival(stage 1)

    Overall survival is defined as time from randomization to death due to any cause.

    Measured: from the date of first dose until the date of death from any cause,assessed up to 2 years

  6. Area under the concentration-time curve (AUC ) following single dose administration of PD-1（stage 1 ）

    Area under the concentration-time curve (AUC ) following single dose administration of PD-1

    Measured: through study completion, an average of 2 years

  7. Peak plasma concentration (Cmax) following single dose administration of PD-1（stage 1 ）

    Peak plasma concentration (Cmax) following single dose administration of PD-1

    Measured: through study completion, an average of 2 years

  8. Steady-state trough serum concentration of multiple Dose Administration of PD-1（stage 2）

    Steady-state trough serum concentrationof multiple Dose Administration of PD-1

    Measured: through study completion, an average of 2 years

  9. Steady-state peak serum concentration of multiple Dose Administration of PD-1（stage 2）

    Steady-state peak serum concentration of multiple Dose Administration of PD-1

    Measured: through study completion, an average of 2 years

  10. Immunogenicity（stage 1 and 2）

    The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab).

    Measured: through study completion, an average of 2 years

Timeline

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

  1. First posted17 Jun 2020
  2. Study start1 Jul 2020 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Nov 2022 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.
Masking
None (open label)
Enrolment
492 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435652
Sponsor's protocol ID
QL1604-302
Status last verified
Jun 2020
First submitted
10 Jun 2020
Last updated
17 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing QL1604, Nab-paclitaxel and Paclitaxel in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, 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 10 inclusion and 17 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 17 Jun 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Shunjiang Yu, CMO (0531-83129659, shunjiang.yu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0 (time frame: Up to 90 days from last 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 NCT04435652.

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 17 Jun 2020.

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