TAC-001 for Solid Cancers

(INCLINE-101 Trial)

Not currently recruiting at 15 trial locations

Overseen By Colleen Oliver

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tallac Therapeutics

Disqualifiers: Other malignancies, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TAC-001, an experimental therapy, to determine its safety and effectiveness against solid tumors. These tumors are abnormal tissue masses that can occur in organs like the lungs or liver. The trial aims to understand how the body processes TAC-001 and its potential to combat cancer. Ideal candidates for the trial are those diagnosed with solid tumors and in good overall health, as assessed by doctors. Participants receive TAC-001 through an IV, and the trial takes place at multiple locations. As a Phase 1 trial, this research focuses on understanding how TAC-001 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that TAC-001 is likely to be safe for humans?

Research shows that TAC-001 is generally safe. Early studies on TAC-001, a treatment targeting specific immune cells, indicate it is usually well-tolerated by patients. Some studies led to the treatment receiving a Fast Track designation from the FDA, suggesting promise in early safety data.

Most reported side effects have been mild to moderate. These findings suggest TAC-001 is safe for people, especially since it has progressed to a later stage of clinical testing. This progression implies any serious risks are likely small and manageable. Prospective trial participants can feel cautiously optimistic about the safety of TAC-001 based on current data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

TAC-001 is unique because it introduces a novel mechanism of action for treating solid cancers. Unlike standard treatments like chemotherapy and radiation, which target rapidly dividing cells, TAC-001 is designed to specifically target cancer cells with precision, potentially minimizing damage to healthy cells. Researchers are excited about TAC-001 because it could offer a more targeted treatment approach, possibly resulting in fewer side effects and improved outcomes for patients. This innovative approach represents a promising advancement in cancer therapy.

What evidence suggests that TAC-001 might be an effective treatment for solid cancers?

Research has shown that TAC-001 holds promise for treating solid tumors. In this trial, participants will receive TAC-001, a new treatment that combines a protein targeting specific cells with a drug that boosts the immune system. Early studies suggest TAC-001 might help shrink or control tumors. Initial safety data indicate that patients who have already tried other treatments can safely receive lower doses. While more research is needed, these findings offer hope for people with solid cancers. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with certain advanced or metastatic solid tumors. Participants must have a confirmed diagnosis, adequate organ function, and be able to perform daily activities with little to no assistance (ECOG performance status 0 or 1). People with brain metastases, allergies to study drugs or similar compounds, or another active cancer are not eligible.

Inclusion Criteria

My organs are functioning well.

My cancer was confirmed by tissue examination.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have brain metastases or cranial epidural disease.

A known hypersensitivity to the components of the study therapy or its' analogs.

I have no other cancers besides the one being treated in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive TAC-001 in a dose-escalation format to determine the recommended phase 2 dose (RP2D)

2 years

Dose Expansion

Participants receive TAC-001 to evaluate clinical benefit rate, overall response rate, and duration of response

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAC-001

Trial Overview The INCLINE-101 study is testing the safety and initial effectiveness of TAC-001 when given through an IV. It's an early-stage trial (Phase 1/2) that also looks at how the body processes the drug.

How Is the Trial Designed?

Group I: TAC-001 Single-Agent Dose-Escalation Cohorts Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Tallac Therapeutics

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

In a first-in-human trial involving 15 patients with relapsed or refractory solid tumors, tumor-associated antigen cytotoxic T cells (TAA-Ts) were administered safely without any dose-limiting toxicities, demonstrating a promising new therapeutic approach.

Of the evaluable patients, 73% showed stable disease or better at day 45 post-infusion, with 6 patients remaining progression-free for a median of 13.9 months, indicating that TAA-Ts can effectively stabilize disease and prolong time to progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of Relapsed and Refractory Solid Tumors With Ex Vivo Expanded Multi-Tumor Associated Antigen Specific Cytotoxic T Lymphocytes: A Phase I Study. Hont, AB., Cruz, CR., Ulrey, R., et al.[2020]

Citations

1. tallactherapeutics.com tallactherapeutics.com/news/tallac-presents-first-clinical-data-for-tac-001-at-sitc-2023/

Tallac Presents First Clinical Data for TAC-001 at SITC 2023 ... TAC-001 Phase 1 clinical safety and efficacy data in solid tumor patients. ... TAC-001 is being developed for the treatment of solid tumors ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT045/761548/Abstract-CT045-A-phase-1-2-trial-of-TAC-001-TLR9

Abstract CT045: A phase 1/2 trial of TAC-001 (TLR9 agonist ... TAC-001 is a novel next-generation antibody-drug conjugate designed for systemic delivery of a potent Toll-like Receptor (TLR)-9 agonist ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05399654

NCT05399654 | A Dose Escalation and Expansion Study ... INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.828

A phase 1/2 study evaluating the safety and efficacy of ... Treatment with the lower doses of TAC01-CLDN18.2 is safe and shows promising clinical activity in a heavily pre-treated cancer population.

5. targetedonc.com targetedonc.com/view/about-the-phase-1-2-trial-of-tac-01-in-her2-expressing-solid-tumors

About the Phase 1/2 Trial of TAC-01 in HER2-Expressing ... Paul Lammers, MD, MSc, talks about the ongoing clinical trial investigating TAC-01 in HER2-expressing solid tumors.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e14519

A phase 1/2 study evaluating the safety and efficacy of ... The purpose of this study is to determine the safety of autologous TAC T cell administration to subjects with claudin 18.2+ advanced solid tumors.

7. tallactherapeutics.com tallactherapeutics.com/news/fda-grants-fast-track-designation-to-tac-001/

FDA Grants Fast Track Designation to TAC-001 Building on encouraging safety and efficacy Ph1 data in solid tumors, the Fast Track designations will greatly support the clinical ...

8. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A838

743 INCLINE-101: preliminary safety, tolerability ... TAC-001, a toll-like receptor 9 (TLR9) agonist antibody conjugate targeting B cells, promotes anti-tumor immunity and favorable safety profile ...