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Advanced or Metastatic Solid TumorsPhase 1NCT06374173

A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors

A Phase 1 study testing TGI-6 Injection in people with Advanced or Metastatic Solid Tumors, run by Hefei TG ImmunoPharma Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
TGI-6 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteChina
Study dates
3 Jan 2024to Dec 2027
Phase
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects age ≥18 years at the time of informed consent.
  • Phase 1a: Subjects with histologically or cytologically diagnosed unresectable locally advanced/metastatic CRC. Or subjects with confirmed B7-H6-positive unresectable locally advanced/metastatic solid tumors, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.
  • Phase 1b Cohort 1: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and/or metastatic CRC.
  • Phase 1b Cohort 2: Subjects must have pathologically documented, definitively diagnosed unresectable locally advanced and/or metastatic solid tumors with B7-H6-positive, mainly but not limited to TNBC, HCC, HNSCC, SCLC, OC, GC, pancreatic cancer, and melanoma.
  • Phase 1a or Phase1b Cohort 2: Subjects should have progressed despite all standard therapy or be intolerant of all standard therapy, or for whom no standard therapy exists. (Standard therapies are defined as treatments recommended by local guidelines, including, but not limited to, chemotherapy, radiation, target therapies based on mutation status, immunotherapy, and surgery in general).
  • All subjects except subjects with CRC must agree to the collection of tumor samples for confirmation of B7-H6 expression status in a central lab.
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  • Subjects in Phase 1a must have at least one evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Subjects in Phase 1b must have least one measurable lesion as defined per RECIST v1.1 which has not received radiotherapy (or progressive disease after radiotherapy).
  • ECOG PS (Appendix 5) of 0~2.
  • Life expectancy ≥3 months.
  • Subjects have sufficient baseline organ function and laboratory data .
  • Woman of childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment.
  • Female subjects of childbearing potential or male subjects with a partner of childbearing potential must agree to use effective contraception at the time of informed consent and continuing through the study until 6 months after the last dose of TGI-6.

Who cannot join

  • Subject with known active central nervous system (CNS) primary tumor or metastases.
  • History of intercurrent severe chronic or active infections.
  • Has a history of active autoimmune diseases .
  • Has a history of symptomatic interstitial lung disease.
  • Toxicities of prior therapies have not been resolved to Grade ≤1 or baseline as per NCI-CTCAE v5.0, except for alopecia, skin hyperpigmentation, Grade 2 neuropathy and Grade 2 endocrinopathy that is well controlled by replacement therapy.
  • Subjects with severe or uncontrolled cardiovascular disorder requiring treatment.
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  • Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years .
  • Evidence of clinically significant immunosuppression .
  • Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures .
  • Previously treated with the following anti-tumor therapy (prior to the first dose of TGI-6):
  • 1) Previous treated with any B7-H6-targeting therapy. 2) Chemotherapy, target therapy, immunotherapy, or other anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment, except:
  • Washout period for nitrosoureas or mitomycin is ≤6 weeks.
  • ≤5 half-lives or 2 weeks (whichever is longer) for fluoropyrimidines or small-molecule targeted agents.
  • Washout period for herbal therapy with anticancer indications is ≤2 weeks. 3) Prior radiotherapy ≤4 weeks prior to the first dose of study treatment, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.
  • 4) Subject participated in any other clinical study and has received an investigational product within 28 days prior to the first dose of TGI-6.
  • 12. Has received systematic immunomodulatory drugs within 14 days before the first dose of study drug, such as thymosin, IL-2, and interferon (IFN).
  • 13. Has received a live vaccine within 4 weeks prior to the first dose of study drug.
  • 14. Has a recent major surgery within 4 weeks prior to the first dose of study drug or is expected to undergo major surgery during the study.
  • 15. Subject requiring anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the Investigator.
  • 16. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
  • 17. Pregnancy or lactation. 18. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  • 19. Pre-existing other serious medical conditions, familial or endemic disease that, in the opinion of the investigator, will interfere with planned staging, treatment, and follow-up, subject compliance, or will place the subject at high risk for treatment-related complications.
  • 20. Subjects who are unwilling or unable to comply with study procedures and study restrictions, or in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaohu Zheng, Doctorate contact

+86 0551-62861151

xiaohu.zheng@tgimmunopharma.com

Hang Zhou, Bachelor contact

+86 0551-62861151

hang.zhou@tgimmunopharma.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing

    Hang Zhou, hang.zhou@tgimmunopharma.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Antitumor Activity of TGI-6 as Monotherapy in Subjects With Locally Advanced/Metastatic Solid Tumors

A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors

Read the detailed description

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of TGI-6 as monotherapy in subjects with unresectable locally advanced/metastatic CRC, or subjects with confirmed B7-H6-positive locally advanced/metastatic solid tumors.

The study consists of two parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period including safety and survival follow-up.

Being tested
TGI-6 Injection
Keywords
TGI6, Colorectal Cancer, solid tumors
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • TGI-6 InjectionDrug

    TGI-6 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

Study groups in NCT06374173
Study groupRoleWhat they receive
TGI-6 InjectionExperimentalTGI-6 monotherapy dose escalation(Phase 1a) . TGI-6 monotherapy dose expansion(Phase 1b) .
Receives: Drug: TGI-6 Injection

What is being measured

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

  1. Dose-limiting Toxicity (DLT)

    The incidence of DLTs during the DLT assessment period.

    Measured: First 21 days of treatment.

  2. Dose-Finding

    Determination of the MTD or maximum tested dose, and the RP2D.

    Measured: Approximately 3 years.

  3. Frequency and Severity of Adverse Events (AE)

    The incidences and percentages of patients experiencing AEs summarized by NCI CTCAE version 5.0 grade and by causality.

    Measured: Screening to 30 days from last dose

Secondary outcomes (8)

  1. Pharmacokinetics of TGI-6

    Maximum Plasma Concentration (Cmax)

    Measured: Day 1 of dosing through 7 days post last dose

  2. Pharmacokinetics of TGI-6

    Area Under the Curve (AUC)

    Measured: Day 1 of dosing through 7 days post last dose

  3. Number of subjects with Anti-TGI-6 antibody positive

    Immunogenicity of TGI-6 monotherapy

    Measured: Day 1 of dosing through 7 days post last dose

  4. Objective Response Rate (ORR)

    ORR according to RECIST v1.1

    Measured: Approximately 3 years.

  5. Duration of Response (DoR)

    Time from the date measurement criteria are first met for PR or CR to the date measurement criteria are first met for progressive disease.

    Measured: Approximately 3 years

  6. Disease Control Rate (DCR)

    The proportion of subjects who have best overall response of CR or PR, or stable disease (SD).

    Measured: Approximately 3 years.

  7. Progression Free Survival (PFS)

    Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.

    Measured: Approximately 3 years.

  8. Overall Survival (OS)

    Time from the date of initiation of study therapy to the date of death from any cause.

    Measured: Approximately 3 years.

Timeline

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

  1. First posted18 Apr 2024
  2. Study start3 Jan 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06374173
Sponsor's protocol ID
TGI6-T1-01
Status last verified
Apr 2024
First submitted
16 Apr 2024
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TGI-6 Injection in people with Advanced or Metastatic Solid Tumors, run by Hefei TG ImmunoPharma 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 12 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 18 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Xiaohu Zheng, Doctorate (+86 0551-62861151, xiaohu.zheng@tgimmunopharma.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: First 21 days of treatment.). 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 NCT06374173.

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 18 Apr 2024.

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