Metastatic Solid TumorPhase 1/2TACTIC-3NCT05862324
TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)
A Phase 1/2 study testing TAC01-CLDN18.2 in people with Metastatic Solid Tumor, run by Triumvira Immunologics, Inc. at 9 sites in 2 countries.
Trial summary
TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2. TAC directs T-cells to the targeted antigen (CLDN 18.2), and once engaged with the target, activates them via the endogenous T cell receptor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- TAC01-CLDN18.2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 23 Aug 2023to 1 Aug 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed, written informed consent obtained before any study procedures are conducted.
- Age ≥ 18 years at the time of informed consent.
- Tumor tissue samples positive for CLDN18.2 as assessed by central laboratory.
- Histologically confirmed advanced, metastatic, unresectable CLDN18.2+ solid tumors after at least 2 lines of prior therapy (Phase 1) and after at least 2 and no more than 4 prior lines of therapy (Phase 2). Subjects with PDAC may have been treated with 1 line of prior therapy.
- Subjects with incurable Claudin 18.2 expressing malignancies for which no standard-of-care targeted therapy exists may be enrolled regardless of the number of prior treatment lines.
- Specific Phase 1 tumor types include gastric, GEJ, esophageal adenocarcinoma, PDAC, colorectal cancer, cholangiocarcinoma, ovarian mucinous cancer, gallbladder cancer and NSCLC.
Show all 19Show fewer
- Specific Phase 2 tumor types include gastric and esophageal adenocarcinoma (Group A), PDAC (Group B), and ovarian or NSCLC (Group C). Other tumor types are not eligible.
- Subjects with solid tumors with genetic alterations and mutations (e.g., BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies, or refused such approved targeted therapy for their cancers, prior to enrollment, or in the opinion of the Investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies.
- Measurable disease per RECIST 1.1 at time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
- Life expectancy of at least 12 weeks.
- Adequate organ and bone marrow reserve function prior to leukapheresis as outlined in protocol.
- Recovery to Grade ≤ 1 or baseline for any toxicities due to previous therapy, except alopecia, anemia, thrombocytopenia, neutropenia, and neuropathy.
- If a subject received major surgery, they must have recovered from the procedure and/or any complications from the procedure prior to starting TAC01-CLDN18.2 therapy.
- Toxicity that has not recovered to Grade ≤ 1 is allowed if it meets the inclusion requirements for laboratory parameters.
- Adequate vascular access for leukapheresis as per institutional standards
- For women physiologically capable of becoming pregnant, agreement to use highly effective methods of contraception starting 28 days prior to study treatment and continue for 1 year after the last TAC01-CLDN18.2 infusion. For men who have partners physiologically capable of becoming pregnant, agreement to use an effective barrier contraceptive method and refrain from donating sperm during study treatment and for 1 year after the last TAC01-CLDN18.2 infusion.
- Subjects who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment. Note: Subjects should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
- Subjects with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening. Note: Subjects must have completed curative antiviral therapy at least 4 weeks prior to enrollment.
Who cannot join
- Intolerant to any component of TAC01-CLDN18.2
- Prior treatment with any of the following:
- Adoptive cell transfer of any kind, including CAR T cells.
- Gene therapy
- Prior treatment with a CLDN18.2 targeted agent (Phase 2 only)
- Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter.
Show all 30Show fewer
- Participation in or has participated in a study using an investigational device within 4 weeks prior to the first dose of study treatment.
- Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study Intervention. Administration of killed vaccines are allowed.
- Radiation within 28 days prior to leukapheresis. Palliative radiation is allowed up to 14 days prior to leukapheresis if additional non-irradiated lesions are present.
- Chemotherapy or targeted small molecule therapy within 14 days prior to leukapheresis, or within 7 days prior to leukapheresis for erlotinib, gefitinib, afatinib, or crizotinib in NSCLC subjects.
- Colony stimulating factors, including granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, and other hematopoietic cytokines, within 14 days prior to leukapheresis.
- Immunosuppressive medication within 14 days or corticosteroid treatment < 72 hours prior to leukapheresis, except for physiological replacement doses (< 12 mg/m2/24 hours of hydrocortisone or equivalent) and topical or inhaled steroids.
- History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study Screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis).
- Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic disease modifying agents in the past 2 years. Hormone replacement therapy (e.g., thyroxine, insulin), or physiologic corticosteroid replacement therapy (for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Active or uncontrolled hepatitis B or C (HCV ribonucleic acid [RNA] positive) infection or any history of or active human immunodeficiency virus (HIV) infection.
- Uncontrolled, acute, or life-threatening bacterial, viral, or fungal infection. Subjects with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible if there is no evidence of active infection (includes COVID positive subjects).
- Class III or IV heart failure (as defined by the New York Heart Association [NYHA]), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease within 6 months prior to Screening.
- Cardiac arrhythmia not controlled by medical management.
- Clinically significant thrombotic events within 3 months prior to leukapheresis and/or inability to stop anticoagulation for at least 2 weeks prior to TAC01-CLDN18.2 infusion without compromising a subject's health (except in subjects with PDAC).
- Prior radiation therapy to the lung > 30 Gy within 6 months of the first dose of study treatment.
- History of Grade ≥ 3 drug-induced pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Ongoing unstable or active gastrointestinal ulcers and gastrointestinal bleeding.
- Complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
- History of organ transplantation or awaiting organ transplantation.
- Known additional malignancy that is progressing or requires active treatment or has been an incurable malignant tumor over the last 5 years. Exceptions include basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Pregnancy or lactation. Females physiologically capable of becoming pregnant must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test result at Screening and within 48 hours prior to the first dose of LDC.
- As determined by the Investigator, any uncontrolled medical, psychological, familial, sociological, or geographical condition(s) that do(es) not permit compliance with the protocol.
- Has a known psychiatric or any disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Cincinnati Cancer Center
Cincinnati, Ohio, 45267
MD Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California San Diego
San Diego, California, 92037
Canada2 sites
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2C1
About this study
Official title: A Phase 1/2 Study Investigating the Safety and Efficacy of Autologous TAC T Cells in Subjects With Unresectable, Locally Advanced or Metastatic Claudin 18.2+ Solid Tumors
TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2. TAC directs T-cells to the targeted antigen (CLDN 18.2), and once engaged with the target, activates them via the endogenous T cell receptor.
This is an open-label, multicenter Phase ½ study that aims to establish safety, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-CLDN18.2.
Read the detailed description
The TAC technology is a novel approach to modifying T cells, herein referred to as TAC T cells, and using them in the treatment of solid tumors. TAC T cells are produced through genetic engineering, incorporating TAC receptors into a patient's own T cells. This redirects these enhanced T cells to specific cancer antigens, and upon recognition, activates them through the natural signaling pathways of the endogenous TCR.
In the TAC01-CLDN18.2 engineered T cell product; TAC T cells recognize the CLDN18.2, a tight junction protein present on the surface of tumor cells, where the protein expression is no longer limited to tight junctions and are visible to T cells to eradicate them. Consequently, it is hypothesized TAC01-CLDN18.2 will be potentially safe and active in treating patients with CLDN18.2+ solid tumors and provide a clinically meaningful therapeutic benefit in patient populations with high unmet medical need.
This is a first-in-human study investigating TAC01-CLDN18.2 to evaluate the safety, MTD or RP2D, PK, and efficacy in subjects with CLDN18.2+ solid tumors who have been treated with at least 2 lines of prior therapy in Phase 1 and after at least 2 lines and no more than 4 lines of prior therapy in Phase 2 (Note: in each phase, subjects with PDAC may have been treated with 1 line of prior antineoplastic therapy. In addition, subjects who are being treated with current lines of therapy, but not deriving benefit or not tolerating therapy, and have not progressed maybe also eligible as long as they have measurable disease at baseline as a starting reference point). In Phase 1, escalating doses of TAC01-CLDN18.2 will be evaluated to identify the RP2D using the classic 3+3 dose escalation study design.
In Phase 2, dose expansion groups will further evaluate the efficacy, safety, and PK of the MTD or RP2D for TAC01-CLDN18.2 in subjects with gastric and esophageal AC (Group A), PDAC (Group B), and mucinous ovarian and NSCLC cancers (Group C). In Phase 2, definitions of eligible CLDN18.2+ IHC expression levels will be based on analysis of data from Phase 1 for signals of clinical activity since there are no formal CAP/ASCO guidelines for CLDN18.2+ expression levels. In Phase 2, a Simon 2-stage design will be used to enroll up to 57 subjects in Group A and 22 subjects in Group C. Group B (PDAC) will enroll up to 10 subjects as an exploratory cohort due to the historically low ORRs observed in PDAC. The 10 treated subjects in Group B are designed to seek evidence of potential clinical activity in this difficult to treat CLDN18.2+ subpopulation of PDAC.
- Conditions
- Metastatic Solid Tumor
- Being tested
- TAC01-CLDN18.2
- Keywords
- Claudin 18.2, Claudin+, Claudin Positive
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAC01-CLDN18.2Biological
TAC01-CLDN18.2 preceded by lymphodepletion with fludarabine or clofarabine, cyclophosphamide, and nab-paclitaxel.
| Study group | Role | What they receive |
|---|---|---|
| TAC01-CLDN18.2 | Experimental | Lymphodepletion followed by TAC01-CLDN18.2 as a single IV infusion. Receives: Biological: TAC01-CLDN18.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Document incidence of DLTs; Type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Measured: 24 Months
Phase 2: Evaluate Overall Response Rate (ORR)
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: 24 Months
Phase 2: Evaluate Duration of Response (DoR)
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death.
Measured: 24 Months
Phase 2: Evaluate Overall survival (OS)
Defined as time from infusion to death from any cause.
Measured: 24 Months
Phase 2: Evaluate Disease control rate (DCR)
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: 24 Months
Phase 2: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Defined as time from infusion to disease progression or death from any cause.
Measured: 24 Months
Secondary outcomes (7)
Phase 1: Determine MTD or RP2D for TAC01-CLDN 18.2
Document incidence of Dose-Limiting Toxicities.
Measured: Up to 29 Days Post TAC01-CLDN18.2 infusion
Phase 1: Evaluate Overall Response Rate (ORR)
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: 24 months
Phase 1: Evaluate Duration of Response (DoR)
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death.
Measured: 24 Months
Phase 1: Evaluate Overall survival (OS)
Defined as time from infusion to death from any cause. Duration of persistence of TAC T cells
Measured: 24 Months
Phase 1: Evaluate Disease control rate (DCR)
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Measured: 24 Months
Phase 1: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Defined as time from infusion to disease progression or death from any cause.
Measured: 24 Months
Phase 2: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Document type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start23 Aug 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In Phase 1, escalating doses of TAC01-CLDN18.2 will be evaluated to identify the RP2D using the classic 3+3 dose escalation study design. In Phase 2, dose expansion groups will further evaluate the safety, efficacy, and PK of the MTD or RP2D for TAC01-CLDN18.2 in subjects with gastric and esophageal AC (Group A), PDAC (Group B), and ovarian and NSCLC cancers (Group C). In Phase 2, definitions of eligible CLDN18.2+ IHC expression levels will be based on retrospective analysis of data from Phase 1 in association with clinical efficacy because there are no formal CAP/ASCO definitions for CLDN18.2+ IHC expression levels. In Phase 2, a Simon 2-stage design will be used to enroll up to 57 subjects in Group A and 22 subjects in Group C. Group B will enroll up to 10 subjects without a Simon 2-stage design due to its historically low ORRs. The 10 treated subjects in Group B are designed to seek evidence of potential efficacy in this difficult to treat CLDN18.2+ subpopulation of PDAC.
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Triumvira Immunologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862324
- Sponsor's protocol ID
- TAC01-CLDN18.2-04
- Acronym
- TACTIC-3
- Status last verified
- Feb 2025
- First submitted
- 8 May 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Investigating the Safety and Efficacy of Autologous TAC T Cells in Subjects With Unresectable, Locally Advanced or Metastatic Claudin 18.2+ Solid Tumors
- ClinicalTrials.gov ID
- NCT05862324
- Acronym / sponsor ID
- TACTIC-3 / TAC01-CLDN18.2-04
- Conditions
- Metastatic Solid Tumor
- Keywords
- Claudin 18.2, Claudin+, Claudin Positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Triumvira Immunologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 17 May 2023 (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.
TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2. TAC directs T-cells to the targeted antigen (CLDN 18.2), and once engaged with the target, activates them via the endogenous T cell receptor.
This is an open-label, multicenter Phase ½ study that aims to establish safety, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-CLDN18.2.
Detailed description
The TAC technology is a novel approach to modifying T cells, herein referred to as TAC T cells, and using them in the treatment of solid tumors. TAC T cells are produced through genetic engineering, incorporating TAC receptors into a patient's own T cells. This redirects these enhanced T cells to specific cancer antigens, and upon recognition, activates them through the natural signaling pathways of the endogenous TCR.
In the TAC01-CLDN18.2 engineered T cell product; TAC T cells recognize the CLDN18.2, a tight junction protein present on the surface of tumor cells, where the protein expression is no longer limited to tight junctions and are visible to T cells to eradicate them. Consequently, it is hypothesized TAC01-CLDN18.2 will be potentially safe and active in treating patients with CLDN18.2+ solid tumors and provide a clinically meaningful therapeutic benefit in patient populations with high unmet medical need.
This is a first-in-human study investigating TAC01-CLDN18.2 to evaluate the safety, MTD or RP2D, PK, and efficacy in subjects with CLDN18.2+ solid tumors who have been treated with at least 2 lines of prior therapy in Phase 1 and after at least 2 lines and no more than 4 lines of prior therapy in Phase 2 (Note: in each phase, subjects with PDAC may have been treated with 1 line of prior antineoplastic therapy. In addition, subjects who are being treated with current lines of therapy, but not deriving benefit or not tolerating therapy, and have not progressed maybe also eligible as long as they have measurable disease at baseline as a starting reference point). In Phase 1, escalating doses of TAC01-CLDN18.2 will be evaluated to identify the RP2D using the classic 3+3 dose escalation study design.
In Phase 2, dose expansion groups will further evaluate the efficacy, safety, and PK of the MTD or RP2D for TAC01-CLDN18.2 in subjects with gastric and esophageal AC (Group A), PDAC (Group B), and mucinous ovarian and NSCLC cancers (Group C). In Phase 2, definitions of eligible CLDN18.2+ IHC expression levels will be based on analysis of data from Phase 1 for signals of clinical activity since there are no formal CAP/ASCO guidelines for CLDN18.2+ expression levels. In Phase 2, a Simon 2-stage design will be used to enroll up to 57 subjects in Group A and 22 subjects in Group C. Group B (PDAC) will enroll up to 10 subjects as an exploratory cohort due to the historically low ORRs observed in PDAC. The 10 treated subjects in Group B are designed to seek evidence of potential clinical activity in this difficult to treat CLDN18.2+ subpopulation of PDAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In Phase 1, escalating doses of TAC01-CLDN18.2 will be evaluated to identify the RP2D using the classic 3+3 dose escalation study design. In Phase 2, dose expansion groups will further evaluate the safety, efficacy, and PK of the MTD or RP2D for TAC01-CLDN18.2 in subjects with gastric and esophageal AC (Group A), PDAC (Group B), and ovarian and NSCLC cancers (Group C). In Phase 2, definitions of eligible CLDN18.2+ IHC expression levels will be based on retrospective analysis of data from Phase 1 in association with clinical efficacy because there are no formal CAP/ASCO definitions for CLDN18.2+ IHC expression levels. In Phase 2, a Simon 2-stage design will be used to enroll up to 57 subjects in Group A and 22 subjects in Group C. Group B will enroll up to 10 subjects without a Simon 2-stage design due to its historically low ORRs. The 10 treated subjects in Group B are designed to seek evidence of potential efficacy in this difficult to treat CLDN18.2+ subpopulation of PDAC.
| Arm | Type | Receives |
|---|---|---|
| TAC01-CLDN18.2 | Experimental | Biological: TAC01-CLDN18.2Lymphodepletion followed by TAC01-CLDN18.2 as a single IV infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed, written informed consent obtained before any study procedures are conducted.
- Age ≥ 18 years at the time of informed consent.
- Tumor tissue samples positive for CLDN18.2 as assessed by central laboratory.
- Histologically confirmed advanced, metastatic, unresectable CLDN18.2+ solid tumors after at least 2 lines of prior therapy (Phase 1) and after at least 2 and no more than 4 prior lines of therapy (Phase 2). Subjects with PDAC may have been treated with 1 line of prior therapy.
- Subjects with solid tumors with genetic alterations and mutations (e.g., BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies, or refused such approved targeted therapy for their cancers, prior to enrollment, or in the opinion of the Investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies.
Key exclusion criteria (30 listed)
- Intolerant to any component of TAC01-CLDN18.2
- Prior treatment with any of the following:
- Prior treatment with a CLDN18.2 targeted agent (Phase 2 only)
- Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter.
- Participation in or has participated in a study using an investigational device within 4 weeks prior to the first dose of study treatment.
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 |
|---|---|---|
| TAC01-CLDN18.2TAC01-CLDN18.2 preceded by lymphodepletion with fludarabine or clofarabine, cyclophosphamide, and nab-paclitaxel. | Biological | TAC01-CLDN18.2 |
Primary outcome
Phase 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 24 Months
Document incidence of DLTs; Type, frequency, and severity of AEs (including clinically significant laboratory abnormalities).
Phase 2: Evaluate Overall Response Rate (ORR)
Time frame: 24 Months
Defined as the percentage of treated subjects with a complete or partial response (CR or PR) as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Phase 2: Evaluate Duration of Response (DoR)
Time frame: 24 Months
Defined as time from first response to disease progression, end of study, start of another anticancer therapy, or death.
Phase 2: Evaluate Overall survival (OS)
Time frame: 24 Months
Defined as time from infusion to death from any cause.
Phase 2: Evaluate Disease control rate (DCR)
Time frame: 24 Months
Defined as the percentage of treated subjects with stable disease (SD), PR, and CR as assessed by imaging using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Phase 2: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Time frame: 24 Months
Defined as time from infusion to disease progression or death from any cause.
7 secondary outcomes
Phase 1: Determine MTD or RP2D for TAC01-CLDN 18.2
Time frame: Up to 29 Days Post TAC01-CLDN18.2 infusion
Phase 1: Evaluate Overall Response Rate (ORR)
Time frame: 24 months
Phase 1: Evaluate Duration of Response (DoR)
Time frame: 24 Months
Phase 1: Evaluate Overall survival (OS)
Time frame: 24 Months
Phase 1: Evaluate Disease control rate (DCR)
Time frame: 24 Months
Phase 1: Evaluate Progression-Free survival (PFS) or Time to progression (TTP)
Time frame: 24 Months
Phase 2: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability).
Time frame: 24 Months
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 14 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAC01-CLDN18.2 in people with Metastatic Solid Tumor, run by Triumvira Immunologics, Inc. at 9 sites in 2 countries.
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 19 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 24 Months). The study lists 6 primary outcomes in all. 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 14 Feb 2025.