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New treatment option for CRC (Colorectal Cancer)
Official title A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07376707
What this study is testing
What is TGI-5?
TGI-5 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crc (colorectal cancer).
Also referred to as Nivolumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Male or female subject age ≥18 years at the time of informed consent. 2. Phase 1a and dose escalation part of Phase 1b: people with...
- Cohort 1: people with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic CRC.
- Cohort 2: people with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic melanoma.
- Cohort 3: people with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic NSCLC.
- Cohort 4: people with other histologically or cytologically diagnosed unresectable locally advanced/metastatic solid tumors. 3\. people should have...
You likely can't join if
- 1\. Subject with known active central nervous system (CNS) primary tumor or metastases. Note: Subject with previously treated CNS primary...
- people with active hepatitis B, defined as: if hepatitis B virus surface antigen (HbsAg) positive, hepatitis B virus (HBV) deoxyribonucleic acid...
- people with active hepatitis C, defined as: if hepatitis C virus (HCV) antibody positive, HCV ribonucleic acid (RNA) assay should be performed, and...
- Known history of acquired immune deficient syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
- people with HIV infection may be eligible if CD4+ T cell counts ≥350 cells/µL and without a history of AIDS-defining opportunistic infections.
- Other severe chronic within 4 weeks prior to the first dose of TGI-5, including but not limited to hospitalization for complications of infection...
See the full eligibility criteria
Who can join
- 1\. Male or female subject age ≥18 years at the time of informed consent. 2. Phase 1a and dose escalation part of Phase 1b: people with histologically or cytologically diagnosed unresectable locally advanced/metastatic...
- Cohort 1: people with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic CRC.
- Cohort 2: people with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic melanoma.
- Cohort 3: people with histologically or cytologically diagnosed unresectable locally advanced and/or metastatic NSCLC.
- Cohort 4: people with other histologically or cytologically diagnosed unresectable locally advanced/metastatic solid tumors. 3\. people should have documented progression of disease despite all standard therapy or are...
- Cohort 1: people with unresectable locally advanced and/or metastatic CRC o At least 2 prior standard chemotherapy/therapy regimens are required with documented progression or intolerability to the treatment.
- Standard chemotherapy regimens include all the following ones (if eligible and no contraindication): Fluoropyrimidine-containing regimen, and/or oxaliplatin-containing regimen, and/or irinotecan-containing regimen...
- With or without an anti-VEGF therapy (e.g., bevacizumab).
- At least one of the anti-EGFR monoclonal antibodies (cetuximab or panitumumab) for KRAS wild-type people if clinically indicated.
- For people with a known microsatellite instability high (MSI-H):
- Prior treatment with an at least 2 doses of approved or investigational immune checkpoint inhibitor is required with documented progression or intolerability to the treatment.
- Demonstrated disease progression after immune checkpoint inhibitor treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix 5). The initial evidence of disease progression is to be...
- Progressive disease that has been documented within 12 weeks from the last dose of immune checkpoint inhibitor. Note: a line of therapy is generally considered \>2 cycles of exposure to the same regimen followed by...
- people must have progressed while receiving or after of the last administration of their last line of standard therapy or be unable to tolerate any of these standard treatments.
- people who progressed on/within 3 months of adjuvant therapy with anti-PD-1 antibody will be allowed; people who received adjuvant chemotherapy and had recurrence/progression with development of unresectable or...
- Cohort 2: people with anti-PD-(L)1 antibody PD-1 relapsed/refractory melanoma
- PD-1 refractory disease as defined as progression on treatment with anti-PD-1 antibody administered either as monotherapy or in combination with other checkpoint inhibitors (anti-CTLA4 antibody or anti-LAG-3 antibody)...
- people who progressed on/within 3 months of adjuvant therapy with anti-PD-1 antibody will be allowed; an adjuvant therapy will count as 1 prior line of therapy if received within the prior 6 months.
- For patients with BRAF V600 mutations, treatment with BRAF and MEK inhibitors prior to initiation on trial is required, unless patients are intolerant of BRAF targeted therapy.
- Treatment must have been discontinued for disease progression or intolerance to therapy.
- Cohort 3: people with anti-PD-(L)1 antibody relapsed/refractory NSCLC o Anti-PD-(L)1 antibody refractory disease as defined as progression on treatment with anti-PD-(L)1 inhibitor administered either as monotherapy or...
- Has received at least 2 doses of an approved or investigational anti-PD-(L)1 inhibitor with documented progression or intolerability to the treatment.
- Has demonstrated disease progression after anti-PD-(L)1 inhibitor as defined by RECIST v1.1 (Appendix 5). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from...
- Progressive disease has been documented within 12 weeks from the last dose of anti-PD-(L)1 inhibitor. o people who progressed on/within 3 months of adjuvant therapy with anti PD (L)1 inhibitor will be allowed; an...
- Patients with NSCLC with known oncogenic driver (including but not limited to EGFR, ALK, ROS, MET alterations) must have received and progressed past driver-specific therapy.
- Treatment must have been discontinued for disease progression or intolerance to therapy.
- Cohort 4: people with other histologically or cytologically diagnosed unresectable locally advanced/metastatic solid tumors All subject in Phase 1b must meet PD-L1 expression ≥1%. 4. people must have at least one...
- Hematological (without need for hematopoietic growth factor or transfusion support within 2 weeks prior to enrollment): 1) ANC ≥1.5×109/L. 2) Hemoglobin (HGB) ≥90 g/L. 3) Platelet (PLT) ≥75×109/L.
- Hepatic: 1) AST and ALT ≤2.5×ULN (≤5×ULN for people with liver metastases). 2) Total bilirubin (TBil) ≤1.5×ULN, or TBil ≤3.0×ULN for people with liver cancer or liver metastases. people with Gilbert's syndrome may...
- Renal: 1) Creatinine apparent clearance (CL) \>50 mL/min according to modification Cockcroft-Gault equation (140-age [year])×body weight [kg]×1.23×(0.85 if female)/serum creatinine [μmol/L]).
- Coagulation: 1) International normalized ratio (INR) ≤1.5. 2) Activated partial thromboplastin time (APTT) ≤1.5×ULN. 8. Woman of child-bearing potential must have a negative serum pregnancy test within 7 days prior to...
What rules you out
- 1\. Subject with known active central nervous system (CNS) primary tumor or metastases. Note: Subject with previously treated CNS primary tumor/metastases can participate provided they are clinically stable for at least...
- people with active hepatitis B, defined as: if hepatitis B virus surface antigen (HbsAg) positive, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) assay should be performed, and HBV DNA is above the limit...
- people with active hepatitis C, defined as: if hepatitis C virus (HCV) antibody positive, HCV ribonucleic acid (RNA) assay should be performed, and HCV RNA is positive.
- Known history of acquired immune deficient syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
- people with HIV infection may be eligible if CD4+ T cell counts ≥350 cells/µL and without a history of AIDS-defining opportunistic infections.
- Other severe chronic within 4 weeks prior to the first dose of TGI-5, including but not limited to hospitalization for complications of infection, bacteremia, severe pneumonia, or active tuberculosis. Or uncontrolled...
- New York Heart Association (NYHA) class III or IV congestive heart failure.
- Left ventricular ejection fraction (LVEF) \<50% assessed by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO).
- Mean ECG QT interval corrected by Fridericia's formula (QTcF) \>480 milliseconds (ms) obtained from triplicate 12-lead ECGs, or congenital long QT syndrome.
- Any of the following within 6 months prior to screening: Grade \>2 ventricular arrhythmia, myocardial infarction, severe/unstable angina (even if controlled with medication), coronary artery bypass graft, congestive...
- Presence of uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg). people with a history of hypertension are allowed if blood pressure is controlled to within these limits...
- Symptomatic pulmonary embolism within 6 months prior to initiation of study treatment. 7\. Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation. 8\. Has a known additional...
- Primary immunodeficiency state such as severe combined immunodeficiency disease (SCID).
- Concurrent opportunistic infection. 10. Presence of uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (monthly or more frequently). 11\. Previously treated with the...
- 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.
- Anti-PD-1/PD-L1 antibody therapy within 6 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.