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Colorectal CancerEarly Phase 1NCT06645301

BGT007 Treatment for Recurrent/refractory Gastrointestinal Malignancies

A Early Phase 1 study testing Group A and Group B in people with Colorectal Cancer and Pancreatic Cancer, run by BioSyngen Pte 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
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Trial summary

This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 ^ 8 3 cases, Group B: 6.0X10 ^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an… Read more about this study

Who is it for?
Ages 17 to 75 years
Conditions the study is for
Colorectal Cancer, Pancreatic Cancer
What is being tested?
Group A and Group B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
30 Nov 2024to 31 Aug 2027
Phase
Early Phase 1
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 17 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1: Voluntarily sign a written informed consent form;
  • 2: Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;
  • 3: Expected survival period ≥ 3 months;
  • 4: The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
  • 5: Biopsy specimens or pathological paraffin sections (within 3 years prior to signing the informed consent form): target tests are both positive;
  • 6: According to the RECIST v1.1 solid tumor evaluation criteria, there must be at least one measurable lesion, and the longest diameter evaluated by CT or MRI imaging in the baseline period must be ≥ 10 mm (excluding lymph nodes, whose short diameter must be ≥ 15 mm);
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  • 7: Advanced pancreatic cancer or colorectal cancer confirmed by histology or cytology, which has progressed through second-line or above standard treatment, or is intolerant of standard treatment, or has no standard treatment; Definition of intolerance: According to CTCAE V5.0, during the treatment process, there is a hematological toxicity of ≥ Grade IV, non hematological toxicity of ≥ Grade III, or damage to major organs such as the heart, liver, and kidneys of ≥ Grade II; The definition of treatment failure: disease progression (PD) during the treatment process or recurrence after treatment (including postoperative recurrence);
  • 8: Can establish a single or intravenous blood collection pathway, and there are no other contraindications for blood cell isolation;
  • 9: Having sufficient organ and bone marrow functions
  • 10: Medical contraceptive measures. Female subjects of childbearing age must undergo a pregnancy test within 72 hours before the first administration, and the result must be negative.

Who cannot join

  • 1: Active central nervous system metastases (excluding those that have been treated and stabilized);
  • 2: HIV positive, HBsAg positive with HBV DNA copy number positive (greater than the detection limit), HCV antibody positive and HCV RNA positive, syphilis non-specific antibody (RPR or TRUST) positive;
  • 3: Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;
  • 4: Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
  • 5: Within the 14 days prior to enrollment, there were active or uncontrollable infections that required systemic treatment;
  • 6: Any unstable systemic disease (including but not limited to): active infection (excluding local infection); Unstable angina pectoris; Cerebrovascular ischemia or cerebrovascular accident (within 6 months prior to screening); Myocardial infarction (within 6 months prior to screening); Congestive heart failure (NYHA classification ≥ III); Severe arrhythmia requiring medication treatment; Heart disease requiring treatment or uncontrolled hypertension after treatment (blood pressure>160mmHg/100 mmHg);
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  • 7: Functional impairment of important organs such as lungs, brain, and kidneys;
  • 8: The subjects have undergone major surgery or severe trauma within 4 weeks prior to receiving treatment with the investigational product, or are expected to undergo major surgery during the study period;
  • 9: Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 2 weeks prior to single collection or within 5 half lives (whichever is shorter);
  • 10: Received treatment with chimeric antigen receptor modified T cells (including CAR-T and TCR-T) within six months;
  • 11: Severe allergies or a history of allergies;
  • 12: Subjects requiring anticoagulant therapy;
  • 13: Pregnant or lactating women, or those with a pregnancy plan within six months (for both men and women)
  • 14: Researchers believe that there are other reasons why treatment providers cannot be included.

Trial locations and contacts

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

Yuqing Li, PhD contact

15018487211

liyu2t@163.com

About this study

Official title: Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrent/refractory Gastrointestinal Malignancies

This study is an exploratory research on single arm, open, and improved "3+3" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 ^ 8 3 cases, Group B: 6.0X10 ^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.

Read the detailed description

Main research objectives:

Evaluate the safety and tolerability of BGT007 in treating patients with recurrent/refractory multiple gastrointestinal malignancies;

Secondary research objective:

  1. Evaluate the pharmacokinetic (PK) characteristics of BGT007;
  2. Evaluate the preliminary effectiveness of BGT007 product.
Being tested
Group A, Group B
Medical subject headings
Colorectal Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • Group ABiological

    BGT007 3.0×10^8cells,Intravenous infusion，3 subject is planned to be enrolled

  • Group BBiological

    BGT007 6.0×10^8cells,Intravenous infusion，6 subject is planned to be enrolled

Study groups in NCT06645301
Study groupRoleWhat they receive
BGT007ExperimentalIntravenous infusion
Receives: Biological: Group A; Biological: Group B

What is being measured

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

  1. Dose-Limiting Toxicity (DLT)

    DLT is defined as the following adverse events related to the investigational drug(definitely related, likely related,possibly related) that occur within 28 days after administration of BGT007 (using CTCAE 5.0 or CRS grading criteria): (1) hematological toxicity; (2) Grade 3 non hematological toxicity lasting for more than 7 days, or ≥ Grade 4 non hematological toxicity, regardless of duration, but excluding the following situations; (3)Cytokine Release Syndrome(CRS)

    Measured: From the infusion (Day 0) to Day 28

  2. Maximum Tolerated Dose(MTD)

    The highest dose of DLT observed in subjects with less than 2/6 (at least 6 subjects in this experimental group received BGT007 administration and completed DLT observation)

    Measured: From the infusion (Day 0) to Day 28

Timeline

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

  1. First posted16 Oct 2024
  2. Study start30 Nov 2024 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06645301
Sponsor's protocol ID
BR-BGT007-001
Status last verified
Oct 2024
First submitted
15 Oct 2024
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Group A and Group B in people with Colorectal Cancer and Pancreatic Cancer, run by BioSyngen Pte 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 10 inclusion and 14 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 16 Oct 2024. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Yuqing Li, PhD (15018487211, liyu2t@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: From the infusion (Day 0) to Day 28). The study lists 2 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 NCT06645301.

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 16 Oct 2024.

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